WorldWideScience

Sample records for research verification trials

  1. Research Areas - Clinical Trials

    Science.gov (United States)

    Information about NCI programs and initiatives that sponsor, conduct, develop, or support clinical trials, including NCI’s Clinical Trial Network (NCTN) and NCI Community Oncology Research Program (NCORP) initiatives.

  2. Neutron spectrometric methods for core inventory verification in research reactors

    International Nuclear Information System (INIS)

    Ellinger, A.; Filges, U.; Hansen, W.; Knorr, J.; Schneider, R.

    2002-01-01

    In consequence of the Non-Proliferation Treaty safeguards, inspections are periodically made in nuclear facilities by the IAEA and the EURATOM Safeguards Directorate. The inspection methods are permanently improved. Therefore, the Core Inventory Verification method is being developed as an indirect method for the verification of the core inventory and to check the declared operation of research reactors

  3. Hybrid approaches to clinical trial monitoring: Practical alternatives to 100% source data verification

    Directory of Open Access Journals (Sweden)

    Sourabh De

    2011-01-01

    Full Text Available For years, a vast majority of clinical trial industry has followed the tenet of 100% source data verification (SDV. This has been driven partly by the overcautious approach to linking quality of data to the extent of monitoring and SDV and partly by being on the safer side of regulations. The regulations however, do not state any upper or lower limits of SDV. What it expects from researchers and the sponsors is methodologies which ensure data quality. How the industry does it is open to innovation and application of statistical methods, targeted and remote monitoring, real time reporting, adaptive monitoring schedules, etc. In short, hybrid approaches to monitoring. Coupled with concepts of optimum monitoring and SDV at site and off-site monitoring techniques, it should be possible to save time required to conduct SDV leading to more available time for other productive activities. Organizations stand to gain directly or indirectly from such savings, whether by diverting the funds back to the R&D pipeline; investing more in technology infrastructure to support large trials; or simply increasing sample size of trials. Whether it also affects the work-life balance of monitors who may then need to travel with a less hectic schedule for the same level of quality and productivity can be predicted only when there is more evidence from field.

  4. Hybrid approaches to clinical trial monitoring: Practical alternatives to 100% source data verification.

    Science.gov (United States)

    De, Sourabh

    2011-07-01

    For years, a vast majority of clinical trial industry has followed the tenet of 100% source data verification (SDV). This has been driven partly by the overcautious approach to linking quality of data to the extent of monitoring and SDV and partly by being on the safer side of regulations. The regulations however, do not state any upper or lower limits of SDV. What it expects from researchers and the sponsors is methodologies which ensure data quality. How the industry does it is open to innovation and application of statistical methods, targeted and remote monitoring, real time reporting, adaptive monitoring schedules, etc. In short, hybrid approaches to monitoring. Coupled with concepts of optimum monitoring and SDV at site and off-site monitoring techniques, it should be possible to save time required to conduct SDV leading to more available time for other productive activities. Organizations stand to gain directly or indirectly from such savings, whether by diverting the funds back to the R&D pipeline; investing more in technology infrastructure to support large trials; or simply increasing sample size of trials. Whether it also affects the work-life balance of monitors who may then need to travel with a less hectic schedule for the same level of quality and productivity can be predicted only when there is more evidence from field.

  5. Current Research on Containment Technologies for Verification Activities: Advanced Tools for Maintaining Continuity of Knowledge

    International Nuclear Information System (INIS)

    Smartt, H.; Kuhn, M.; Krementz, D.

    2015-01-01

    The U.S. National Nuclear Security Administration (NNSA) Office of Non-proliferation and Verification Research and Development currently funds research on advanced containment technologies to support Continuity of Knowledge (CoK) objectives for verification regimes. One effort in this area is the Advanced Tools for Maintaining Continuity of Knowledge (ATCK) project. Recognizing that CoK assurances must withstand potential threats from sophisticated adversaries, and that containment options must therefore keep pace with technology advances, the NNSA research and development on advanced containment tools is an important investment. The two ATCK efforts underway at present address the technical containment requirements for securing access points (loop seals) and protecting defined volumes. Multiple U.S. national laboratories are supporting this project: Sandia National Laboratories (SNL), Savannah River National Laboratory (SRNL), and Oak Ridge National Laboratory (ORNL). SNL and SRNL are developing the ''Ceramic Seal,'' an active loop seal that integrates multiple advanced security capabilities and improved efficiency housed within a small-volume ceramic body. The development includes an associated handheld reader and interface software. Currently at the prototype stage, the Ceramic Seal will undergo a series of tests to determine operational readiness. It will be field tested in a representative verification trial in 2016. ORNL is developing the Whole Volume Containment Seal (WCS), a flexible conductive fabric capable of enclosing various sizes and shapes of monitored items. The WCS includes a distributed impedance measurement system for imaging the fabric surface area and passive tamper-indicating features such as permanent-staining conductive ink. With the expected technology advances from the Ceramic Seal and WCS, the ATCK project takes significant steps in advancing containment technologies to help maintain CoK for various verification

  6. Measuring Data Quality Through a Source Data Verification Audit in a Clinical Research Setting.

    Science.gov (United States)

    Houston, Lauren; Probst, Yasmine; Humphries, Allison

    2015-01-01

    Health data has long been scrutinised in relation to data quality and integrity problems. Currently, no internationally accepted or "gold standard" method exists measuring data quality and error rates within datasets. We conducted a source data verification (SDV) audit on a prospective clinical trial dataset. An audit plan was applied to conduct 100% manual verification checks on a 10% random sample of participant files. A quality assurance rule was developed, whereby if >5% of data variables were incorrect a second 10% random sample would be extracted from the trial data set. Error was coded: correct, incorrect (valid or invalid), not recorded or not entered. Audit-1 had a total error of 33% and audit-2 36%. The physiological section was the only audit section to have <5% error. Data not recorded to case report forms had the greatest impact on error calculations. A significant association (p=0.00) was found between audit-1 and audit-2 and whether or not data was deemed correct or incorrect. Our study developed a straightforward method to perform a SDV audit. An audit rule was identified and error coding was implemented. Findings demonstrate that monitoring data quality by a SDV audit can identify data quality and integrity issues within clinical research settings allowing quality improvement to be made. The authors suggest this approach be implemented for future research.

  7. An unattended verification station for UF6 cylinders: Field trial findings

    Science.gov (United States)

    Smith, L. E.; Miller, K. A.; McDonald, B. S.; Webster, J. B.; Zalavadia, M. A.; Garner, J. R.; Stewart, S. L.; Branney, S. J.; Todd, L. C.; Deshmukh, N. S.; Nordquist, H. A.; Kulisek, J. A.; Swinhoe, M. T.

    2017-12-01

    In recent years, the International Atomic Energy Agency (IAEA) has pursued innovative techniques and an integrated suite of safeguards measures to address the verification challenges posed by the front end of the nuclear fuel cycle. Among the unattended instruments currently being explored by the IAEA is an Unattended Cylinder Verification Station (UCVS), which could provide automated, independent verification of the declared relative enrichment, 235U mass, total uranium mass, and identification for all declared uranium hexafluoride cylinders in a facility (e.g., uranium enrichment plants and fuel fabrication plants). Under the auspices of the United States and European Commission Support Programs to the IAEA, a project was undertaken to assess the technical and practical viability of the UCVS concept. The first phase of the UCVS viability study was centered on a long-term field trial of a prototype UCVS system at a fuel fabrication facility. A key outcome of the study was a quantitative performance evaluation of two nondestructive assay (NDA) methods being considered for inclusion in a UCVS: Hybrid Enrichment Verification Array (HEVA), and Passive Neutron Enrichment Meter (PNEM). This paper provides a description of the UCVS prototype design and an overview of the long-term field trial. Analysis results and interpretation are presented with a focus on the performance of PNEM and HEVA for the assay of over 200 "typical" Type 30B cylinders, and the viability of an "NDA Fingerprint" concept as a high-fidelity means to periodically verify that material diversion has not occurred.

  8. Participant verification: Prevention of co‑enrolment in clinical trials in ...

    African Journals Online (AJOL)

    Methods. The Medical Research Council (MRC) HIV Prevention Research ... which uses fingerprint-based biometric technology to identify participants. ... and clinical trial sites, with new participant information loaded at first visit to a trial site.

  9. Assessing data quality and the variability of source data verification auditing methods in clinical research settings.

    Science.gov (United States)

    Houston, Lauren; Probst, Yasmine; Martin, Allison

    2018-05-18

    Data audits within clinical settings are extensively used as a major strategy to identify errors, monitor study operations and ensure high-quality data. However, clinical trial guidelines are non-specific in regards to recommended frequency, timing and nature of data audits. The absence of a well-defined data quality definition and method to measure error undermines the reliability of data quality assessment. This review aimed to assess the variability of source data verification (SDV) auditing methods to monitor data quality in a clinical research setting. The scientific databases MEDLINE, Scopus and Science Direct were searched for English language publications, with no date limits applied. Studies were considered if they included data from a clinical trial or clinical research setting and measured and/or reported data quality using a SDV auditing method. In total 15 publications were included. The nature and extent of SDV audit methods in the articles varied widely, depending upon the complexity of the source document, type of study, variables measured (primary or secondary), data audit proportion (3-100%) and collection frequency (6-24 months). Methods for coding, classifying and calculating error were also inconsistent. Transcription errors and inexperienced personnel were the main source of reported error. Repeated SDV audits using the same dataset demonstrated ∼40% improvement in data accuracy and completeness over time. No description was given in regards to what determines poor data quality in clinical trials. A wide range of SDV auditing methods are reported in the published literature though no uniform SDV auditing method could be determined for "best practice" in clinical trials. Published audit methodology articles are warranted for the development of a standardised SDV auditing method to monitor data quality in clinical research settings. Copyright © 2018. Published by Elsevier Inc.

  10. The verification of neutron activation analysis support system (cooperative research)

    Energy Technology Data Exchange (ETDEWEB)

    Sasajima, Fumio; Ichimura, Shigeju; Ohtomo, Akitoshi; Takayanagi, Masaji [Japan Atomic Energy Research Inst., Tokai, Ibaraki (Japan). Tokai Research Establishment; Sawahata, Hiroyuki; Ito, Yasuo [Tokyo Univ. (Japan). Research Center for Nuclear Science and Technology; Onizawa, Kouji [Radiation Application Development Association, Tokai, Ibaraki (Japan)

    2000-12-01

    Neutron activation analysis support system is the system in which even the user who has not much experience in the neutron activation analysis can conveniently and accurately carry out the multi-element analysis of the sample. In this verification test, subjects such functions, usability, precision and accuracy of the analysis and etc. of the neutron activation analysis support system were confirmed. As a method of the verification test, it was carried out using irradiation device, measuring device, automatic sample changer and analyzer equipped in the JRR-3M PN-3 facility, and analysis software KAYZERO/SOLCOI based on the k{sub 0} method. With these equipments, calibration of the germanium detector, measurement of the parameter of the irradiation field and analysis of three kinds of environmental standard sample were carried out. The k{sub 0} method adopted in this system is primarily utilized in Europe recently, and it is the analysis method, which can conveniently and accurately carried out the multi-element analysis of the sample without requiring individual comparison standard sample. By this system, total 28 elements were determined quantitatively, and 16 elements with the value guaranteed as analytical data of the NIST (National Institute of Standards and Technology) environment standard sample were analyzed in the accuracy within 15%. This report describes content and verification result of neutron activation support system. (author)

  11. Participant verification: prevention of co-enrolment in clinical trials in South Africa.

    Science.gov (United States)

    Harichund, C; Haripersad, K; Ramjee, R

    2013-05-15

    As KwaZulu-Natal Province is the epicentre of the HIV epidemic in both South Africa (SA) and globally, it is an ideal location to conduct HIV prevention and therapeutic trials. Numerous prevention trials are currently being conducted here; the potential for participant co-enrolment may compromise the validity of these studies and is therefore of great concern. To report the development and feasibility of a digital, fingerprint-based participant identification method to prevent co-enrolment at multiple clinical trial sites. The Medical Research Council (MRC) HIV Prevention Research Unit (HPRU) developed the Biometric Co-enrolment Prevention System (BCEPS), which uses fingerprint-based biometric technology to identify participants. A trial website was used to determine the robustness and usability of the system. After successful testing, the BCEPS was piloted in July 2010 across 7 HPRU clinical research sites. The BCEPS was pre-loaded with study names and clinical trial sites, with new participant information loaded at first visit to a trial site. We successfully implemented the BCEPS at the 7 HPRU sites. Using the BCEPS, we performed real-time 'flagging' of women who were already enrolled in another study as they entered a trial at an HPRU site and, where necessary, excluded them from participation on site. This system has promise in reducing co-enrolment in clinical trials and represents a valuable tool for future implementation by all groups conducting trials. The MRC is currently co-ordinating this effort with clinical trial sites nationally.

  12. Sustaining a verification regime in a nuclear weapon-free world. VERTIC research report no. 4

    International Nuclear Information System (INIS)

    Moyland, S. van

    1999-01-01

    Sustaining high levels of commitment to and enthusiasm for the verification regime in a nuclear weapon-free world (NWFW) would be a considerable challenge, but the price of failure would be high. No verification system for a complete ban on a whole of weapon of mass destruction (WMD) has been in existence long enough to provide a precedent or the requisite experience. Nevertheless, lessons from the International Atomic Energy Agency's (IAEA) nuclear safeguards system are instructive. A potential problem over the long haul is the gradual erosion of the deterrent effect of verification that may result from the continual overlooking of minor instances of non-compliance. Flaws in the verification system must be identified and dealt with early lest they also corrode the system. To achieve this the verification organisation's inspectors and analytical staff will need sustained support, encouragement, resources and training. In drawing attention to weaknesses, they must be supported by management and at the political level. The leaking of sensitive information, either industrial or military, by staff of the verification regime is a potential problem. 'Managed access' techniques should be constantly examined and improved. The verification organisation and states parties will need to sustain close co-operation with the nuclear and related industries. Frequent review mechanisms must be established. States must invest time and effort to make them effective. Another potential problem is the withering of resources for sustained verification. Verification organisations tend to be pressured by states to cut or last least cap costs, even if the verification workload increases. The verification system must be effective as knowledge and experience allows. The organisation will need continuously to update its scientific methods and technology. This requires in-house resources plus external research and development (R and D). Universities, laboratories and industry need incentives to

  13. NIH Clinical Research Trials and You

    Science.gov (United States)

    ... Info Lines Health Services Locator HealthCare.gov NIH Clinical Research Trials and You Talking to Your Doctor Science ... Labs & Clinics Training Opportunities Library Resources Research Resources Clinical Research Resources Safety, Regulation and Guidance More » Quick Links ...

  14. Determining the Accuracy of Crowdsourced Tweet Verification for Auroral Research

    Directory of Open Access Journals (Sweden)

    Nathan A. Case

    2016-12-01

    Full Text Available The Aurorasaurus project harnesses volunteer crowdsourcing to identify sightings of an aurora (the “northern/southern lights” posted by citizen scientists on Twitter. Previous studies have demonstrated that aurora sightings can be mined from Twitter with the caveat that there is a large background level of non-sighting tweets, especially during periods of low auroral activity. Aurorasaurus attempts to mitigate this, and thus increase the quality of its Twitter sighting data, by using volunteers to sift through a pre-filtered list of geolocated tweets to verify real-time aurora sightings. In this study, the current implementation of this crowdsourced verification system, including the process of geolocating tweets, is described and its accuracy (which, overall, is found to be 68.4% is determined. The findings suggest that citizen science volunteers are able to accurately filter out unrelated, spam-like, Twitter data but struggle when filtering out somewhat related, yet undesired, data. The citizen scientists particularly struggle with determining the real-time nature of the sightings, so care must be taken when relying on crowdsourced identification.

  15. VAMOS: The verification and monitoring options study: Current research options for in-situ monitoring and verification of contaminant remediation and containment within the vadose zone

    International Nuclear Information System (INIS)

    Betsill, J.D.; Gruebel, R.D.

    1995-09-01

    The Verification and Monitoring Options Study Project (VAMOS) was established to identify high-priority options for future vadose-zone environmental research in the areas of in-situ remediation monitoring, post-closure monitoring, and containment emplacement and verification monitoring. VAMOS examined projected needs not currently being met with applied technology in order to develop viable monitoring and verification research options. The study emphasized a compatible systems approach to reinforce the need for utilizing compatible components to provide user friendly site monitoring systems. To identify the needs and research options related to vadose-zone environmental monitoring and verification, a literature search and expert panel forums were conducted. The search included present drivers for environmental monitoring technology, technology applications, and research efforts. The forums included scientific, academic, industry, and regulatory environmental professionals as well as end users of environmental technology. The experts evaluated current and future monitoring and verification needs, methods for meeting these needs, and viable research options and directions. A variety of high-priority technology development, user facility, and technology guidance research options were developed and presented as an outcome of the literature search and expert panel forums

  16. Clinical verification of genetic results returned to research participants: findings from a Colon Cancer Family Registry.

    Science.gov (United States)

    Laurino, Mercy Y; Truitt, Anjali R; Tenney, Lederle; Fisher, Douglass; Lindor, Noralane M; Veenstra, David; Jarvik, Gail P; Newcomb, Polly A; Fullerton, Stephanie M

    2017-11-01

    The extent to which participants act to clinically verify research results is largely unknown. This study examined whether participants who received Lynch syndrome (LS)-related findings pursued researchers' recommendation to clinically verify results with testing performed by a CLIA-certified laboratory. The Fred Hutchinson Cancer Research Center site of the multinational Colon Cancer Family Registry offered non-CLIA individual genetic research results to select registry participants (cases and their enrolled relatives) from 2011 to 2013. Participants who elected to receive results were counseled on the importance of verifying results at a CLIA-certified laboratory. Twenty-six (76.5%) of the 34 participants who received genetic results completed 2- and 12-month postdisclosure surveys; 42.3% of these (11/26) participated in a semistructured follow-up interview. Within 12 months of result disclosure, only 4 (15.4%) of 26 participants reported having verified their results in a CLIA-certified laboratory; of these four cases, all research and clinical results were concordant. Reasons for pursuing clinical verification included acting on the recommendation of the research team and informing future clinical care. Those who did not verify results cited lack of insurance coverage and limited perceived personal benefit of clinical verification as reasons for inaction. These findings suggest researchers will need to address barriers to seeking clinical verification in order to ensure that the intended benefits of returning genetic research results are realized. © 2017 The Authors. Molecular Genetics & Genomic Medicine published by Wiley Periodicals, Inc.

  17. Seismic monitoring: a unified system for research and verifications

    International Nuclear Information System (INIS)

    Thigpen, L.

    1979-01-01

    A system for characterizing either a seismic source or geologic media from observational data was developed. This resulted from an examination of the forward and inverse problems of seismology. The system integrates many seismic monitoring research efforts into a single computational capability. Its main advantage is that it unifies computational and research efforts in seismic monitoring. 173 references, 9 figures, 3 tables

  18. Research on the experimental verification of dosimetry calculations. Progress report

    International Nuclear Information System (INIS)

    Poston, J.W.

    1984-06-01

    Research has been focused on the development of a technique to section PATE organ dosimeters and the application of the technique to dosimetry of the extremities. In addition, a realistic model for the head and neck region has been designed and a model for the circulating blood has been proposed

  19. Clinical trials: bringing research to the bedside.

    Science.gov (United States)

    Arvay, C A

    1991-02-01

    Over the years, clinical trials with their structured treatment plans and multicenter involvement have been instrumental in developing new treatments and establishing standard of care therapy. While clinical trials strive to advance medical knowledge, they provide scientifically sound, state of the art care and their use should be increased. The Brain Tumor Cooperative Group, one such NCI-sponsored cooperative group, has been the primary group for the treatment of malignant gliomas. As the field of neuro-oncology expands, the neuroscience nurse needs to develop an understanding of clinical trials and their operation. The nurse is in an optimal position to support medical research and the research participant.

  20. Research on Elemental Technology of Advanced Nuclear Fuel Performance Verification

    International Nuclear Information System (INIS)

    Kim, Yong Soo; Lee, Dong Uk; Jean, Sang Hwan; Koo, Min

    2003-04-01

    Most of current properties models and fuel performance models used in the performance evaluation codes are based on the in-pile data up to 33,000 MWd/MtU. Therefore, international experts are investigating the properties changes and developing advanced prediction models for high burn-up application. Current research is to develop high burn-up fission gas release model for the code and to support the code development activities by collecting data and models, reviewing/assessing the data and models together, and benchmarking the selected models against the appropriate in-pile data. For high burn-up applications, two stage two step fission gas release model is developed based on the real two diffusion process in the grain lattice and grain boundaries of the fission gases and the observation of accelerated release rate in the high burn-up. It is found that the prediction of this model is in excellent agreement with the in-pile measurement results, not only in the low burn-up but also in the high burn-up. This research is found that the importance of thermal conductivity of oxide fuel, especially in the high burn-up, is focused again. It is found that even the temperature dependent models differ from one to another and most of them overestimate the conductivity in the high burn-up. An in-pile data benchmarking of high LHGR fuel rod shows that the difference can reach 30%∼40%, which predicts 400 .deg. C lower than the real fuel centerline temperature. Recent models on the thermal expansion and heat capacity of oxide fuel are found to be well-defined. Irradiation swelling of the oxide fuel are now well-understood that in most cases in LWRs solid fission product swelling is dominant. Thus, the accumulation of in-pile data can enhance the accuracy of the model prediction, rather than theoretical modeling works. Thermo-physical properties of Zircaloy cladding are also well-defined and well-understood except the thermal expansion. However, it turns out that even the

  1. Clinical Research and Clinical Trials

    Science.gov (United States)

    ... Research Information Find a Study Resources and Publications HIV/AIDS Condition Information NICHD Research Information Find a ... Videos Get to Know NICHD Podcasts and Audio Social Media Join ... aims to advance medical knowledge by studying people, either through direct interaction or through the collection and analysis of blood, ...

  2. 76 FR 81991 - National Spectrum Sharing Research Experimentation, Validation, Verification, Demonstration and...

    Science.gov (United States)

    2011-12-29

    ... NATIONAL SCIENCE FOUNDATION National Spectrum Sharing Research Experimentation, Validation... requirements of national level spectrum research, development, demonstration, and field trial facilities... to determine the optimal way to manage and use the radio spectrum. During Workshop I held at Boulder...

  3. Employing 3D Virtual Reality and the Unity Game Engine to Support Nuclear Verification Research

    International Nuclear Information System (INIS)

    Patton, T.

    2015-01-01

    This project centres on the development of a virtual nuclear facility environment to assist non-proliferation and nuclear arms control practitioners - including researchers, negotiators, or inspectors - in developing and refining a verification system and secure chain of custody of material or equipment. The platform for creating the virtual facility environment is the Unity 3D game engine. This advanced platform offers both the robust capability and flexibility necessary to support the design goals of the facility. The project also employs Trimble SketchUp and Blender 3D for constructing the model components. The development goal of this phase of the project was to generate a virtual environment that includes basic physics in which avatars can interact with their environment through actions such as picking up objects, operating vehicles, dismantling a warhead through a spherical representation system, opening/closing doors through a custom security access system, and conducting CCTV surveillance. Initial testing of virtual radiation simulation techniques was also explored in preparation for the next phase of development. Some of the eventual utilities and applications for this platform include: 1. conducting live multi-person exercises of verification activities within a single, shared virtual environment, 2. refining procedures, individual roles, and equipment placement in the contexts of non-proliferation or arms control negotiations 3. hands on training for inspectors, and 4. a portable tool/reference for inspectors to use while carrying out inspections. This project was developed under the Multilateral Verification Project, led by the Verification Research, Training and Information Centre (VERTIC) in the United Kingdom, and financed by the Norwegian Ministry of Foreign Affairs. The environment was constructed at the Vienna Center for Disarmament and Non-Proliferation (VCDNP). (author)

  4. Public information about clinical trials and research.

    Science.gov (United States)

    Plétan, Yannick; Zannad, Faïez; Jaillon, Patrice

    2003-01-01

    Be it to restore the confused image of clinical research in relation to the lay public, or to develop new ways of accruing healthy volunteers or patients for clinical trials, there is a need to draft some guidance on how best to provide information on research. Although the French legal and regulatory armamentarium in this area is essentially liberal, there is currently little-justified reluctance among study sponsors to advertise publicly. A group of academic and pharmaceutical industry researchers, assembled for a workshop, together with regulators, journalists, representatives from ethics committees, social security, patient and health consumer groups and other French institutional bodies, has suggested the following series of recommendations: there is no need for additional legal or regulatory constraints; sponsors should be aware of and make use of direct public information on trials; a 'good practice charter' on public communication about clinical trials should be developed; all professionals should be involved in this communication platform; communication in the patient's immediate vicinity should be preferred (primary-care physician, local press); clinical databases and websites accessible to professionals, but also to patients and non-professionals, should be developed; genuine instruction on clinical trials for physicians and health professionals unfamiliar with such trials should be developed and disseminated; media groups should receive at least some training in the fundamentals of clinical research.

  5. Remote source document verification in two national clinical trials networks: a pilot study.

    Directory of Open Access Journals (Sweden)

    Meredith Mealer

    Full Text Available OBJECTIVE: Barriers to executing large-scale randomized controlled trials include costs, complexity, and regulatory requirements. We hypothesized that source document verification (SDV via remote electronic monitoring is feasible. METHODS: Five hospitals from two NIH sponsored networks provided remote electronic access to study monitors. We evaluated pre-visit remote SDV compared to traditional on-site SDV using a randomized convenience sample of all study subjects due for a monitoring visit. The number of data values verified and the time to perform remote and on-site SDV was collected. RESULTS: Thirty-two study subjects were randomized to either remote SDV (N=16 or traditional on-site SDV (N=16. Technical capabilities, remote access policies and regulatory requirements varied widely across sites. In the adult network, only 14 of 2965 data values (0.47% could not be located remotely. In the traditional on-site SDV arm, 3 of 2608 data values (0.12% required coordinator help. In the pediatric network, all 198 data values in the remote SDV arm and all 183 data values in the on-site SDV arm were located. Although not statistically significant there was a consistent trend for more time consumed per data value (minutes +/- SD: Adult 0.50 +/- 0.17 min vs. 0.39 +/- 0.10 min (two-tailed t-test p=0.11; Pediatric 0.99 +/- 1.07 min vs. 0.56 +/- 0.61 min (p=0.37 and time per case report form: Adult: 4.60 +/- 1.42 min vs. 3.60 +/- 0.96 min (p=0.10; Pediatric: 11.64 +/- 7.54 min vs. 6.07 +/- 3.18 min (p=0.10 using remote SDV. CONCLUSIONS: Because each site had different policies, requirements, and technologies, a common approach to assimilating monitors into the access management system could not be implemented. Despite substantial technology differences, more than 99% of data values were successfully monitored remotely. This pilot study demonstrates the feasibility of remote monitoring and the need to develop consistent access policies for remote study

  6. Preliminary Research on the Verification Task of North Korea's Plutonium Declaration

    International Nuclear Information System (INIS)

    Kim, Hyun Chul; Park, Il Jin

    2009-01-01

    The denuclearization of North Korea seems challenging. North Korea has recognized itself as a nuclear weapon state by carrying out two nuclear tests while many other nations including South Korea have opposed North Korea's nuclear proliferation. As a result of longstanding negotiations, North Korea provided nearly 19,000 pages of operation history of three Yongbyon nuclear facilities on May 8, 2008 and a 60-page declaration of its nuclear activities and programs on June 26, 2008. However, one should notice that declaration documents are by themselves meaningless without their verification. To completely dismantle North Korea's nuclear programs, the verification task based on its declaration documents should be performed very thoroughly, considering the possibility of the presence of the undeclared nuclear materials and facilities. The verification task of North Korea's nuclear declaration consists of many broad themes to deal with, such as the review of declaration documents, the interview with facility operators, the sampling in the field, the laboratory analysis of the sample, data interpretation, and so on. One of the important themes is to verify North Korea's declared plutonium stockpile by comparing the declaration documents with measurement data which can be obtained from the sampling in the field and laboratory analysis. To prepare for the possible future verification of the declared plutonium stockpile, it is meaningful to give a thought on what data can be compared and what samples need to be taken and analyzed. In this study, we focus on the data to be compared and samples to be taken and analyzed for the plutonium accounting, as a preliminary research. To give a quantitative example, the nuclear material of the most recent North Korea's spent fuel rods discharged from the 5 MWe reactor is analyzed. On June 13, 2009, North Korea declared that more than one-third of the spent fuel rods had been reprocessed

  7. Randomised controlled trials in Scandinavian educational research

    DEFF Research Database (Denmark)

    Pontoppidan, Maiken; Keilow, Maria; Dietrichson, Jens

    2018-01-01

    of this paper is to examine the history of randomised controlled trials in Scandinavian compulsory schools (grades 0–10; pupil ages 6-15). Specifically, we investigate drivers and barriers for randomised controlled trials in educational research and the differences between the three Scandinavian countries...... crucial for the implementation of RCTs and are likely more important in smaller countries such as the Scandinavian ones. Supporting institutions have now been established in all three countries, and we believe that the use of RCTs in Scandinavian educational research is likely to continue....... or more interventions were randomly assigned to groups of students and carried out in a school setting with the primary aim of improving the academic performance of children aged 6-15 in grades 0–10 in Denmark, Norway, or Sweden. We included both conducted and ongoing trials. Publications that seemed...

  8. Efficient design of clinical trials and epidemiological research: is it possible?

    Science.gov (United States)

    Lauer, Michael S; Gordon, David; Wei, Gina; Pearson, Gail

    2017-08-01

    Randomized clinical trials and large-scale, cohort studies continue to have a critical role in generating evidence in cardiovascular medicine; however, the increasing concern is that ballooning costs threaten the clinical trial enterprise. In this Perspectives article, we discuss the changing landscape of clinical research, and clinical trials in particular, focusing on reasons for the increasing costs and inefficiencies. These reasons include excessively complex design, overly restrictive inclusion and exclusion criteria, burdensome regulations, excessive source-data verification, and concerns about the effect of clinical research conduct on workflow. Thought leaders have called on the clinical research community to consider alternative, transformative business models, including those models that focus on simplicity and leveraging of digital resources. We present some examples of innovative approaches by which some investigators have successfully conducted large-scale, clinical trials at relatively low cost. These examples include randomized registry trials, cluster-randomized trials, adaptive trials, and trials that are fully embedded within digital clinical care or administrative platforms.

  9. Initial verification and validation of RAZORBACK - A research reactor transient analysis code

    Energy Technology Data Exchange (ETDEWEB)

    Talley, Darren G. [Sandia National Laboratories (SNL-NM), Albuquerque, NM (United States)

    2015-09-01

    This report describes the work and results of the initial verification and validation (V&V) of the beta release of the Razorback code. Razorback is a computer code designed to simulate the operation of a research reactor (such as the Annular Core Research Reactor (ACRR)) by a coupled numerical solution of the point reactor kinetics equations, the energy conservation equation for fuel element heat transfer, and the mass, momentum, and energy conservation equations for the water cooling of the fuel elements. This initial V&V effort was intended to confirm that the code work to-date shows good agreement between simulation and actual ACRR operations, indicating that the subsequent V&V effort for the official release of the code will be successful.

  10. Maximising the value of combining qualitative research and randomised controlled trials in health research: the QUAlitative Research in Trials (QUART) study--a mixed methods study.

    Science.gov (United States)

    O'Cathain, Alicia; Thomas, Kate J; Drabble, Sarah J; Rudolph, Anne; Goode, Jackie; Hewison, Jenny

    2014-06-01

    Researchers sometimes undertake qualitative research with randomised controlled trials (RCTs) of health interventions. To systematically explore how qualitative research is being used with trials and identify ways of maximising its value to the trial aim of providing evidence of effectiveness of health interventions. A sequential mixed methods study with four components. (1) Database search of peer-reviewed journals between January 2008 and September 2010 for articles reporting the qualitative research undertaken with specific trials, (2) systematic search of database of registered trials to identify studies combining qualitative research and trials, (3) survey of 200 lead investigators of trials with no apparent qualitative research and (4) semistructured telephone interviews with 18 researchers purposively sampled from the first three methods. Qualitative research was undertaken with at least 12% of trials. A large number of articles reporting qualitative research undertaken with trials (n=296) were published between 2008 and 2010. A total of 28% (82/296) of articles reported qualitative research undertaken at the pre-trial stage and around one-quarter concerned drugs or devices. The articles focused on 22 aspects of the trial within five broad categories. Some focused on more than one aspect of the trial, totalling 356 examples. The qualitative research focused on the intervention being trialled (71%, 254/356), the design and conduct of the trial (15%, 54/356), the outcomes of the trial (1%, 5/356), the measures used in the trial (3%, 10/356), and the health condition in the trial (9%, 33/356). The potential value of the qualitative research to the trial endeavour included improving the external validity of trials and facilitating interpretation of trial findings. This value could be maximised by using qualitative research more at the pre-trial stage and reporting findings with explicit attention to the implications for the trial endeavour. During interviews

  11. Development and verification of remote research environment based on 'Fusion research grid'

    International Nuclear Information System (INIS)

    Iba, Katsuyuki; Ozeki, Takahisa; Totsuka, Toshiyuki; Suzuki, Yoshio; Oshima, Takayuki; Sakata, Shinya; Sato, Minoru; Suzuki, Mitsuhiro; Hamamatsu, Kiyotaka; Kiyono, Kimihiro

    2008-01-01

    'Fusion research grid' is a concept that unites scientists and let them collaborate effectively against their difference in time zone and location in a nuclear fusion research. Fundamental technologies of 'Fusion research grid' have been developed at JAEA in the VizGrid project under the e-Japan project at the Ministry of Education, Culture, Sports, Science and Technology (MEXT). We are conscious of needs to create new systems that assist researchers with their research activities because remote collaborations have been increasing in international projects. Therefore we have developed prototype remote research environments for experiments, diagnostics, analyses and communications based on 'Fusion research grid'. All users can access these environments from anywhere because 'Fusion research grid' does not require a closed network like Super SINET to maintain security. The prototype systems were verified in experiments at JT-60U and their availability was confirmed

  12. Research on key technology of the verification system of steel rule based on vision measurement

    Science.gov (United States)

    Jia, Siyuan; Wang, Zhong; Liu, Changjie; Fu, Luhua; Li, Yiming; Lu, Ruijun

    2018-01-01

    The steel rule plays an important role in quantity transmission. However, the traditional verification method of steel rule based on manual operation and reading brings about low precision and low efficiency. A machine vison based verification system of steel rule is designed referring to JJG1-1999-Verificaiton Regulation of Steel Rule [1]. What differentiates this system is that it uses a new calibration method of pixel equivalent and decontaminates the surface of steel rule. Experiments show that these two methods fully meet the requirements of the verification system. Measuring results strongly prove that these methods not only meet the precision of verification regulation, but also improve the reliability and efficiency of the verification system.

  13. The research for the design verification of nuclear power plant based on VR dynamic plant

    International Nuclear Information System (INIS)

    Wang Yong; Yu Xiao

    2015-01-01

    This paper studies a new method of design verification through the VR plant, in order to perform verification and validation the design of plant conform to the requirements of accident emergency. The VR dynamic plant is established by 3D design model and digital maps that composed of GIS system and indoor maps, and driven by the analyze data of design analyzer. The VR plant could present the operation conditions and accident conditions of power plant. This paper simulates the execution of accident procedures, the development of accidents, the evacuation planning of people and so on, based on VR dynamic plant, and ensure that the plant design will not cause bad effect. Besides design verification, simulated result also can be used for optimization of the accident emergency plan, the training of accident plan and emergency accident treatment. (author)

  14. Verification of effect of sleep health education program in workplace: a quasi-randomized controlled trial.

    Science.gov (United States)

    Nakada, Yukari; Sugimoto, Aya; Kadotani, Hiroshi; Yamada, Naoto

    2018-02-07

    Short sleep duration is a serious problem that not only enhances the risk of various mental and physical disorders, but also affects the productivity in the workplace. However, in terms of studies focused on workers, there are few reports that evaluated sleeping conditions in an objective way. The purpose of this study is to implement sleep health education in the workplace in terms of primary prevention of mental health disorder and then to investigate the subjective and objective effectiveness of the education using self-administered questionnaires (sleep duration, ESS, AIS, PHQ-9, SF-8) and an activity monitor (MTN-210). Study design is a quasi-randomized controlled trial. Sleep health education was provided through three 50-min lectures (total 150 min) as a single cycle for five months in the Intervention group. We obtained baseline data and then six months later. The study analyzed 70 subjects (36 Intervention group, 34 Control group). The weekday sleep duration for the Control group decreased by 12.9 min, whereas that of the Intervention group increased by 14.3 min (difference of 27.2 min), resulting in a significantly increase in score for the Intervention group. The present study suggests that sleep health education may be beneficial for good sleep habits in workers.

  15. Clinical Trials: A Crucial Key to Human Health Research

    Science.gov (United States)

    ... Past Issues Clinical Trials: A Crucial Key to Human Health Research Past Issues / Summer 2006 Table of Contents ... Javascript on. Photo: PhotoDisc At the forefront of human health research today are clinical trials—studies that use ...

  16. Qualitative research within trials: developing a standard operating procedure for a clinical trials unit

    Science.gov (United States)

    2013-01-01

    Background Qualitative research methods are increasingly used within clinical trials to address broader research questions than can be addressed by quantitative methods alone. These methods enable health professionals, service users, and other stakeholders to contribute their views and experiences to evaluation of healthcare treatments, interventions, or policies, and influence the design of trials. Qualitative data often contribute information that is better able to reform policy or influence design. Methods Health services researchers, including trialists, clinicians, and qualitative researchers, worked collaboratively to develop a comprehensive portfolio of standard operating procedures (SOPs) for the West Wales Organisation for Rigorous Trials in Health (WWORTH), a clinical trials unit (CTU) at Swansea University, which has recently achieved registration with the UK Clinical Research Collaboration (UKCRC). Although the UKCRC requires a total of 25 SOPs from registered CTUs, WWORTH chose to add an additional qualitative-methods SOP (QM-SOP). Results The qualitative methods SOP (QM-SOP) defines good practice in designing and implementing qualitative components of trials, while allowing flexibility of approach and method. Its basic principles are that: qualitative researchers should be contributors from the start of trials with qualitative potential; the qualitative component should have clear aims; and the main study publication should report on the qualitative component. Conclusions We recommend that CTUs consider developing a QM-SOP to enhance the conduct of quantitative trials by adding qualitative data and analysis. We judge that this improves the value of quantitative trials, and contributes to the future development of multi-method trials. PMID:23433341

  17. Authentication scheme for routine verification of genetically similar laboratory colonies: a trial with Anopheles gambiae

    Directory of Open Access Journals (Sweden)

    Sutcliffe Alice C

    2009-10-01

    Full Text Available Abstract Background When rearing morphologically indistinguishable laboratory strains concurrently, the threat of unintentional genetic contamination is constant. Avoidance of accidental mixing of strains is difficult due to the use of common equipment, technician error, or the possibility of self relocation by adult mosquitoes ("free fliers". In many cases, laboratory strains are difficult to distinguish because of morphological and genetic similarity, especially when laboratory colonies are isolates of certain traits from the same parental strain, such as eye color mutants, individuals with certain chromosomal arrangements or high levels of insecticide resistance. Thus, proving genetic integrity could seem incredibly time-consuming or impossible. On the other hand, lacking proof of genetically isolated laboratory strains could question the validity of research results. Results We present a method for establishing authentication matrices to routinely distinguish and confirm that laboratory strains have not become physically or genetically mixed through contamination events in the laboratory. We show a specific example with application to Anopheles gambiae sensu stricto strains at the Malaria Research and Reference Reagent Resource Center. This authentication matrix is essentially a series of tests yielding a strain-specific combination of results. Conclusion These matrix-based methodologies are useful for several mosquito and insect populations but must be specifically tailored and altered for each laboratory based on the potential contaminants available at any given time. The desired resulting authentication plan would utilize the least amount of routine effort possible while ensuring the integrity of the strains.

  18. Conducting qualitative research within Clinical Trials Units: avoiding potential pitfalls.

    Science.gov (United States)

    Cooper, Cindy; O'Cathain, Alicia; Hind, Danny; Adamson, Joy; Lawton, Julia; Baird, Wendy

    2014-07-01

    The value of using qualitative research within or alongside randomised controlled trials (RCTs) is becoming more widely accepted. Qualitative research may be conducted concurrently with pilot or full RCTs to understand the feasibility and acceptability of the interventions being tested, or to improve trial conduct. Clinical Trials Units (CTUs) in the United Kingdom (UK) manage large numbers of RCTs and, increasingly, manage the qualitative research or collaborate with qualitative researchers external to the CTU. CTUs are beginning to explicitly manage the process, for example, through the use of standard operating procedures for designing and implementing qualitative research with trials. We reviewed the experiences of two UK Clinical Research Collaboration (UKCRC) registered CTUs of conducting qualitative research concurrently with RCTs. Drawing on experiences gained from 15 studies, we identify the potential for the qualitative research to undermine the successful completion or scientific integrity of RCTs. We show that potential problems can arise from feedback of interim or final qualitative findings to members of the trial team or beyond, in particular reporting qualitative findings whilst the trial is on-going. The problems include: We make recommendations for improving the management of qualitative research within CTUs. Copyright © 2014. Published by Elsevier Inc.

  19. Research on verification and validation strategy of detonation fluid dynamics code of LAD2D

    Science.gov (United States)

    Wang, R. L.; Liang, X.; Liu, X. Z.

    2017-07-01

    The verification and validation (V&V) is an important approach in the software quality assurance of code in complex engineering application. Reasonable and efficient V&V strategy can achieve twice the result with half the effort. This article introduces the software-Lagrangian adaptive hydrodynamics code in 2D space (LAD2D), which is self-developed software in detonation CFD with plastic-elastic structure. The V&V strategy of this detonation CFD code is presented based on the foundation of V&V methodology for scientific software. The basic framework of the module verification and the function validation is proposed, composing the detonation fluid dynamics model V&V strategy of LAD2D.

  20. Qualitative research within trials: developing a standard operating procedure for a clinical trials unit

    OpenAIRE

    Rapport, Frances; Clement, Clare

    2013-01-01

    BackgroundQualitative research methods are increasingly used within trials to address broader research questions than quantitative methods can address alone. Qualitative methods enable health professionals, service users and other stakeholders to contribute their views and experiences when evaluating health care treatments, interventions or policies. They can influence trial design, allowing for a fuller engagement with research questions, aims and objectives and clarify the complexities of p...

  1. Research on Linux Trusted Boot Method Based on Reverse Integrity Verification

    Directory of Open Access Journals (Sweden)

    Chenlin Huang

    2016-01-01

    Full Text Available Trusted computing aims to build a trusted computing environment for information systems with the help of secure hardware TPM, which has been proved to be an effective way against network security threats. However, the TPM chips are not yet widely deployed in most computing devices so far, thus limiting the applied scope of trusted computing technology. To solve the problem of lacking trusted hardware in existing computing platform, an alternative security hardware USBKey is introduced in this paper to simulate the basic functions of TPM and a new reverse USBKey-based integrity verification model is proposed to implement the reverse integrity verification of the operating system boot process, which can achieve the effect of trusted boot of the operating system in end systems without TPMs. A Linux operating system booting method based on reverse integrity verification is designed and implemented in this paper, with which the integrity of data and executable files in the operating system are verified and protected during the trusted boot process phase by phase. It implements the trusted boot of operation system without TPM and supports remote attestation of the platform. Enhanced by our method, the flexibility of the trusted computing technology is greatly improved and it is possible for trusted computing to be applied in large-scale computing environment.

  2. Can emergency medicine research benefit from adaptive design clinical trials?

    Science.gov (United States)

    Flight, Laura; Julious, Steven A; Goodacre, Steve

    2017-04-01

    Adaptive design clinical trials use preplanned interim analyses to determine whether studies should be stopped or modified before recruitment is complete. Emergency medicine trials are well suited to these designs as many have a short time to primary outcome relative to the length of recruitment. We hypothesised that the majority of published emergency medicine trials have the potential to use a simple adaptive trial design. We reviewed clinical trials published in three emergency medicine journals between January 2003 and December 2013. We determined the proportion that used an adaptive design as well as the proportion that could have used a simple adaptive design based on the time to primary outcome and length of recruitment. Only 19 of 188 trials included in the review were considered to have used an adaptive trial design. A total of 154/165 trials that were fixed in design had the potential to use an adaptive design. Currently, there seems to be limited uptake in the use of adaptive trial designs in emergency medicine despite their potential benefits to save time and resources. Failing to take advantage of adaptive designs could be costly to patients and research. It is recommended that where practical and logistical considerations allow, adaptive designs should be used for all emergency medicine clinical trials. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  3. Construction of ethics in clinical research: clinical trials registration

    OpenAIRE

    C. A. Caramori

    2007-01-01

    Scientific development that has been achieved through decades finds in clinical research a great possibility of translating findings to human health application. Evidence given by clinical trials allows everyone to have access to the best health services. However, the millionaire world of pharmaceutical industries has stained clinical research with doubt and improbability. Study results (fruits of controlled clinical trials) and scientific publications (selective, manipulated and with wrong c...

  4. Construction of ethics in clinical research: clinical trials registration

    Directory of Open Access Journals (Sweden)

    C. A. Caramori

    2007-01-01

    Full Text Available Scientific development that has been achieved through decades finds in clinical research a great possibility of translating findings to human health application. Evidence given by clinical trials allows everyone to have access to the best health services. However, the millionaire world of pharmaceutical industries has stained clinical research with doubt and improbability. Study results (fruits of controlled clinical trials and scientific publications (selective, manipulated and with wrong conclusions led to an inappropriate clinical practice, favoring the involved economic aspect. In 2005, the International Committee of Medical Journal Editors (ICMJE, supported by the World Association of Medical Editors, started demanding as a requisite for publication that all clinical trials be registered at the database ClinicalTrials.gov. In 2006, the World Health Organization (WHO created the International Clinical Trial Registry Platform (ICTRP, which gathers several registry centers from all over the world, and required that all researchers and pharmaceutical industries register clinical trials. Such obligatory registration has progressed and will extend to all scientific journals indexed in all worldwide databases. Registration of clinical trials means another step of clinical research towards transparency, ethics and impartiality, resulting in real evidence to the forthcoming changes in clinical practice as well as in the health situation.

  5. Application verification research of cloud computing technology in the field of real time aerospace experiment

    Science.gov (United States)

    Wan, Junwei; Chen, Hongyan; Zhao, Jing

    2017-08-01

    According to the requirements of real-time, reliability and safety for aerospace experiment, the single center cloud computing technology application verification platform is constructed. At the IAAS level, the feasibility of the cloud computing technology be applied to the field of aerospace experiment is tested and verified. Based on the analysis of the test results, a preliminary conclusion is obtained: Cloud computing platform can be applied to the aerospace experiment computing intensive business. For I/O intensive business, it is recommended to use the traditional physical machine.

  6. Research on database realization technology of seismic information system in CTBT verification

    International Nuclear Information System (INIS)

    Zheng Xuefeng; Shen Junyi; Zhang Huimin; Jing Ping; Sun Peng; Zheng Jiangling

    2005-01-01

    Developing CTBT verification technology has become the most important method that makes sure CTBT to be fulfilled conscientiously. The seismic analysis based on seismic information system (SIS) is playing an important rule in this field. Based on GIS, the SIS will be very sufficient and powerful in spatial analysis, topologic analysis and visualization. However, the critical issue to implement the whole system function depends on the performance of SIS DB. Based on the ArcSDE Geodatabase data model, not only have the spatial data and attribute data seamless integrated management been realized with RDBMS ORACLE really, but also the most functions of ORACLE have been reserved. (authors)

  7. ENVIRONMENTAL TECHNOLOGY VERIFICATION REPORT, ENVIRONMENTAL DECISION SUPPORT SOFTWARE, UNIVERSITY OF TENNESSEE RESEARCH CORPORATION, SPATIAL ANALYSIS AND DECISION ASSISTANCE (SADA)

    Science.gov (United States)

    The U.S. Environmental Protection Agency (EPA) has created the Environmental Technology Verification Program (ETV) to facilitate the deployment of innovative or improved environmental technologies through performance verification and dissemination of information. The goal of the...

  8. DEPSCOR: Research on ARL's Intelligent Control Architecture: Hierarchical Hybrid-Model Based Design, Verification, Simulation, and Synthesis of Mission Control for Autonomous Underwater Vehicles

    National Research Council Canada - National Science Library

    Kumar, Ratnesh; Holloway, Lawrence E

    2007-01-01

    ... modeling, verification, simulation and automated synthesis of coordinators has lead to research in this area. We have worked and are working on these issues with Applied Research Laboratory (ARL) at Pennsylvania State University (PSU) who have designed autonomous underwater vehicles for over 50 years primarily under the support of the U.S. Navy through the Office of Naval Research (ONR).

  9. Working Group 2: Future Directions for Safeguards and Verification, Technology, Research and Development

    International Nuclear Information System (INIS)

    Zykov, S.; Blair, D.

    2013-01-01

    For traditional safeguards it was recognized that the hardware presently available is, in general, addressing adequately fundamental IAEA needs, and that further developments should therefore focus mainly on improving efficiencies (i.e. increasing cost economies, reliability, maintainability and user-friendliness, keeping abreast of continual advancements in technologies and of the evolution of verification approaches). Specific technology areas that could benefit from further development include: -) Non-destructive measurement systems (NDA), in particular, gamma-spectroscopy and neutron counting techniques; -) Containment and surveillance tools, such as tamper indicating seals, video-surveillance, surface identification methods, etc.; -) Geophysical methods for design information verification (DIV) and safeguarding of geological repositories; and -) New tools and methods for real-time monitoring. Furthermore, the Working Group acknowledged that a 'building block' (or modular) approach should be adopted towards technology development, enabling equipment to be upgraded efficiently as technologies advance. Concerning non-traditional safeguards, in the area of satellite-based sensors, increased spatial resolution and broadened spectral range were identified as priorities. In the area of wide area surveillance, the development of LIDAR-like tools for atmospheric sensing was discussed from the perspective of both potential benefits and certain limitations. Recognizing the limitations imposed by the human brain in terms of information assessment and analysis, technologies are needed that will enable the more effective utilization of all information, regardless of its format and origin. The paper is followed by the slides of the presentation. (A.C.)

  10. Randomised controlled trials in educational research

    African Journals Online (AJOL)

    2016-05-02

    May 2, 2016 ... Evidence-based practice (EBP) is positioned as an inherent good in the medical and clinical literature, and not without reason. It relies on the integration of research evidence, clinical expertise and patient preferences,[1] and has become a foundation on which health systems are built and improved.

  11. Consumer input into research: the Australian Cancer Trials website.

    Science.gov (United States)

    Dear, Rachel F; Barratt, Alexandra L; Crossing, Sally; Butow, Phyllis N; Hanson, Susan; Tattersall, Martin Hn

    2011-06-26

    The Australian Cancer Trials website (ACTO) was publicly launched in 2010 to help people search for cancer clinical trials recruiting in Australia, provide information about clinical trials and assist with doctor-patient communication about trials. We describe consumer involvement in the design and development of ACTO and report our preliminary patient evaluation of the website. Consumers, led by Cancer Voices NSW, provided the impetus to develop the website. Consumer representative groups were consulted by the research team during the design and development of ACTO which combines a search engine, trial details, general information about trial participation and question prompt lists. Website use was analysed. A patient evaluation questionnaire was completed at one hospital, one week after exposure to the website. ACTO's main features and content reflect consumer input. In February 2011, it covered 1, 042 cancer trials. Since ACTO's public launch in November 2010, until the end of February 2011, the website has had 2, 549 new visits and generated 17, 833 page views. In a sub-study of 47 patient users, 89% found the website helpful for learning about clinical trials and all respondents thought patients should have access to ACTO. The development of ACTO is an example of consumers working with doctors, researchers and policy makers to improve the information available to people whose lives are affected by cancer and to help them participate in their treatment decisions, including consideration of clinical trial enrolment. Consumer input has ensured that the website is informative, targets consumer priorities and is user-friendly. ACTO serves as a model for other health conditions.

  12. Consumer input into research: the Australian Cancer Trials website

    Directory of Open Access Journals (Sweden)

    Butow Phyllis N

    2011-06-01

    Full Text Available Abstract Background The Australian Cancer Trials website (ACTO was publicly launched in 2010 to help people search for cancer clinical trials recruiting in Australia, provide information about clinical trials and assist with doctor-patient communication about trials. We describe consumer involvement in the design and development of ACTO and report our preliminary patient evaluation of the website. Methods Consumers, led by Cancer Voices NSW, provided the impetus to develop the website. Consumer representative groups were consulted by the research team during the design and development of ACTO which combines a search engine, trial details, general information about trial participation and question prompt lists. Website use was analysed. A patient evaluation questionnaire was completed at one hospital, one week after exposure to the website. Results ACTO's main features and content reflect consumer input. In February 2011, it covered 1, 042 cancer trials. Since ACTO's public launch in November 2010, until the end of February 2011, the website has had 2, 549 new visits and generated 17, 833 page views. In a sub-study of 47 patient users, 89% found the website helpful for learning about clinical trials and all respondents thought patients should have access to ACTO. Conclusions The development of ACTO is an example of consumers working with doctors, researchers and policy makers to improve the information available to people whose lives are affected by cancer and to help them participate in their treatment decisions, including consideration of clinical trial enrolment. Consumer input has ensured that the website is informative, targets consumer priorities and is user-friendly. ACTO serves as a model for other health conditions.

  13. Research on MRV system of iron and steel industry and verification mechanism establishment in China

    Science.gov (United States)

    Guo, Huiting; Chen, Liang; Chen, Jianhua

    2017-12-01

    The national carbon emissions trading market will be launched in 2017 in China. The iron and steel industry will be covered as one of the first industries. Establishing its MRV system is critical to promote the development of the iron and steel industry in the carbon trading market. This paper studies the requirements and procedures of the accounting, monitoring, reporting and verification of the seven iron and steel industry carbon trading pilots. The construction and operating mechanism of the MRV systems are also analyzed. Combining with the emission feature of the iron and steel industry, we study the suitable national MRV system for the whole iron and steel industry to consummate the future national carbon trading framework of iron and steel industry.

  14. RAZORBACK - A Research Reactor Transient Analysis Code Version 1.0 - Volume 3: Verification and Validation Report.

    Energy Technology Data Exchange (ETDEWEB)

    Talley, Darren G.

    2017-04-01

    This report describes the work and results of the verification and validation (V&V) of the version 1.0 release of the Razorback code. Razorback is a computer code designed to simulate the operation of a research reactor (such as the Annular Core Research Reactor (ACRR)) by a coupled numerical solution of the point reactor kinetics equations, the energy conservation equation for fuel element heat transfer, the equation of motion for fuel element thermal expansion, and the mass, momentum, and energy conservation equations for the water cooling of the fuel elements. This V&V effort was intended to confirm that the code shows good agreement between simulation and actual ACRR operations.

  15. SU-F-T-440: The Feasibility Research of Checking Cervical Cancer IMRT Pre- Treatment Dose Verification by Automated Treatment Planning Verification System

    Energy Technology Data Exchange (ETDEWEB)

    Liu, X; Yin, Y; Lin, X [Shandong Cancer Hospital and Institute, China, Jinan, Shandong (China)

    2016-06-15

    Purpose: To assess the preliminary feasibility of automated treatment planning verification system in cervical cancer IMRT pre-treatment dose verification. Methods: The study selected randomly clinical IMRT treatment planning data for twenty patients with cervical cancer, all IMRT plans were divided into 7 fields to meet the dosimetric goals using a commercial treatment planning system(PianncleVersion 9.2and the EclipseVersion 13.5). The plans were exported to the Mobius 3D (M3D)server percentage differences of volume of a region of interest (ROI) and dose calculation of target region and organ at risk were evaluated, in order to validate the accuracy automated treatment planning verification system. Results: The difference of volume for Pinnacle to M3D was less than results for Eclipse to M3D in ROI, the biggest difference was 0.22± 0.69%, 3.5±1.89% for Pinnacle and Eclipse respectively. M3D showed slightly better agreement in dose of target and organ at risk compared with TPS. But after recalculating plans by M3D, dose difference for Pinnacle was less than Eclipse on average, results were within 3%. Conclusion: The method of utilizing the automated treatment planning system to validate the accuracy of plans is convenientbut the scope of differences still need more clinical patient cases to determine. At present, it should be used as a secondary check tool to improve safety in the clinical treatment planning.

  16. Guidance for Researchers Developing and Conducting Clinical Trials in Practice-based Research Networks (PBRNs)

    Science.gov (United States)

    Dolor, Rowena J.; Schmit, Kristine M.; Graham, Deborah G.; Fox, Chester H.; Baldwin, Laura Mae

    2015-01-01

    Background There is increased interest nationally in multicenter clinical trials to answer questions about clinical effectiveness, comparative effectiveness, and safety in real-world community settings. Primary care practice-based research networks (PBRNs), comprising community- and/or academically affiliated practices committed to improving medical care for a range of health problems, offer ideal settings for these trials, especially pragmatic clinical trials. However, many researchers are not familiar with working with PBRNs. Methods Experts in practice-based research identified solutions to challenges that researchers and PBRN personnel experience when collaborating on clinical trials in PBRNs. These were organized as frequently asked questions in a draft document presented at a 2013 Agency for Health care Research and Quality PBRN conference workshop, revised based on participant feedback, then shared with additional experts from the DARTNet Institute, Clinical Translational Science Award PBRN, and North American Primary Care Research Group PBRN workgroups for further input and modification. Results The “Toolkit for Developing and Conducting Multi-site Clinical Trials in Practice-Based Research Networks” offers guidance in the areas of recruiting and engaging practices, budgeting, project management, and communication, as well as templates and examples of tools important in developing and conducting clinical trials. Conclusion Ensuring the successful development and conduct of clinical trials in PBRNs requires a highly collaborative approach between academic research and PBRN teams. PMID:25381071

  17. The Efficacy of Social Media as a Research Tool and Information Source for Safeguards Verification

    International Nuclear Information System (INIS)

    Skoeld, T.; Feldman, Y.

    2015-01-01

    The IAEA Department of Safeguards aims to provide credible assurances to the international community that States are fulfiling their safeguards obligations in that all nuclear material remains in peaceful use. In order to draw a soundly-based safeguards conclusion for a State that has a safeguards agreement in force with the IAEA, the Department establishes a knowledge base of the State's nuclear-related infrastructure and activities against which a State's declarations are evaluated for correctness and completeness. Open source information is one stream of data that is used in the evaluation of nuclear fuel cycle activities in the State. The Department is continuously working to ensure that it has access to the most up-to-date, accurate, relevant and credible open source information available, and has begun to examine the use of social media as a new source of information. The use of social networking sites has increased exponentially in the last decade. In fact, social media has emerged as the key vehicle for delivering and acquiring information in near real-time. Therefore, it has become necessary for the open source analyst to consider social media as an essential element in the broader concept of open source information. Characteristics, such as ''immediacy'', ''recency'', ''interractiveness'', which set social networks apart from the ''traditional media'', are also the same attributes that present a challenge for using social media as an efficient information-delivery platform and a credible source of information. New tools and technologies for social media analytics have begun to emerge to help systematically monitor and mine this large body of data. The paper will survey the social media landscape in an effort to identify platforms that could be of value for safeguards verification purposes. It will explore how a number of social networking sites, such as Twitter

  18. Achievement report on developing superconductor power applied technologies in fiscal 1999 (2). Research and development of superconductor wire materials, research and development of superconductor power generators, research of total systems, research and development of freezing systems, and verification tests; 1999 nendo chodendo denryoku oyo gijutsu kaihatsu seika hokokusho. 2. Chodendo senzai no kenkyu kaihatsu / chodendo hatsudenki no kenkyu kaihatsu / total system no kenkyu / reito system no kenkyu kaihatsu / jissho shiken

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2000-03-01

    With an objective to achieve higher efficiency, higher density, and higher stability in power systems, research and development has been performed on superconductor power generators. This paper summarizes the achievements thereof in fiscal 1999. A verification test was given on the rotor of an ultra high speed responding generator. In a sudden short circuit test using the different phase charging method, no anomalies were found such as quench generation and vibration changes, wherein the healthiness of the generator was verified. In the VVVF actuation test, knowledge was acquired on the actuation method when the ultra high speed responding generator is applied to a combined cycle plant. After the verification test has been completed, the disassembly inspections such as visual check and non-destructive test were performed. With regard to the vacuum leakage found in the rotor under very low temperatures, the causes were presumed and the countermeasures were discussed by observing the weld structures. In the design research, the conception design on the 200-MW pilot generator was reviewed by reflecting the results of the verification tests on the model generator. At the same time, trial design was made on a 600-MW target generator. In summarizing the overall research achievements, the achievements and evaluations were summarized on technological issues that have been allotted to each research member. (NEDO)

  19. The Ethics of Clinical Trials Research in Severe Mood Disorders.

    Science.gov (United States)

    Nugent, Allison C; Miller, Franklin G; Henter, Ioline D; Zarate, Carlos A

    2017-07-01

    Mood disorders, including major depressive disorder (MDD) and bipolar disorder (BD), are highly prevalent, frequently disabling, and sometimes deadly. Additional research and more effective medications are desperately needed, but clinical trials research in mood disorders is fraught with ethical issues. Although many authors have discussed these issues, most do so from a theoretical viewpoint. This manuscript uses available empirical data to inform a discussion of the primary ethical issues raised in mood disorders research. These include issues of consent and decision-making capacity, including patients' motivations for participating in research. We also address drug withdrawals, placebo controls, and the overall safety of research. Finally, we examine the extant literature for studies discussing potential indirect benefits of clinical trials research to participants. Taken together, the evidence suggests that clinical trials research incorporating drug withdrawals and placebo controls can be conducted safely and ethically, even in patients with severe or treatment-resistant mood disorders. In fact, given the dearth of effective treatment options for this population, it is our opinion that a moral imperative exists to extend the offer of research participation to severely ill or treatment-resistant groups. Published 2017. This article is a U.S. Government work and is in the public domain in the USA.

  20. More ethical and more efficient clinical research: multiplex trial design.

    Science.gov (United States)

    Keus, Frederik; van der Horst, Iwan C C; Nijsten, Maarten W

    2014-08-14

    Today's clinical research faces challenges such as a lack of clinical equipoise between treatment arms, reluctance in randomizing for multiple treatments simultaneously, inability to address interactions and increasingly restricted resources. Furthermore, many trials are biased by extensive exclusion criteria, relatively small sample size and less appropriate outcome measures. We propose a 'Multiplex' trial design that preserves clinical equipoise with a continuous and factorial trial design that will also result in more efficient use of resources. This multiplex design accommodates subtrials with appropriate choice of treatment arms within each subtrial. Clinical equipoise should increase consent rates while the factorial design is the best way to identify interactions. The multiplex design may evolve naturally from today's research limitations and challenges, while principal objections seem absent. However this new design poses important infrastructural, organisational and psychological challenges that need in depth consideration.

  1. Maximising the impact of qualitative research in feasibility studies for randomised controlled trials: guidance for researchers

    NARCIS (Netherlands)

    O’Cathain, A.; Hoddinott, P.; Lewin, S.; Thomas, K.J.; Young, B.; Adamson, J.; Jansen, J.F.M.; Mills, N.; Moore, G.; Donovan, J.L.

    2015-01-01

    Feasibility studies are increasingly undertaken in preparation for randomised controlled trials in order to explore uncertainties and enable trialists to optimise the intervention or the conduct of the trial. Qualitative research can be used to examine and address key uncertainties prior to a full

  2. Identifying research priorities for effective retention strategies in clinical trials.

    Science.gov (United States)

    Kearney, Anna; Daykin, Anne; Shaw, Alison R G; Lane, Athene J; Blazeby, Jane M; Clarke, Mike; Williamson, Paula; Gamble, Carrol

    2017-08-31

    The failure to retain patients or collect primary-outcome data is a common challenge for trials and reduces the statistical power and potentially introduces bias into the analysis. Identifying strategies to minimise missing data was the second highest methodological research priority in a Delphi survey of the Directors of UK Clinical Trial Units (CTUs) and is important to minimise waste in research. Our aim was to assess the current retention practices within the UK and priorities for future research to evaluate the effectiveness of strategies to reduce attrition. Seventy-five chief investigators of NIHR Health Technology Assessment (HTA)-funded trials starting between 2009 and 2012 were surveyed to elicit their awareness about causes of missing data within their trial and recommended practices for improving retention. Forty-seven CTUs registered within the UKCRC network were surveyed separately to identify approaches and strategies being used to mitigate missing data across trials. Responses from the current practice surveys were used to inform a subsequent two-round Delphi survey with registered CTUs. A consensus list of retention research strategies was produced and ranked by priority. Fifty out of seventy-five (67%) chief investigators and 33/47 (70%) registered CTUs completed the current practice surveys. Seventy-eight percent of trialists were aware of retention challenges and implemented strategies at trial design. Patient-initiated withdrawal was the most common cause of missing data. Registered CTUs routinely used newsletters, timeline of participant visits, and telephone reminders to mitigate missing data. Whilst 36 out of 59 strategies presented had been formally or informally evaluated, some frequently used strategies, such as site initiation training, have had no research to inform practice. Thirty-five registered CTUs (74%) participated in the Delphi survey. Research into the effectiveness of site initiation training, frequency of patient contact

  3. An Issues-Based Research Project: National Goals on Trial.

    Science.gov (United States)

    DeVille, Priscilla; And Others

    This paper summarizes the results of a research project completed by three doctoral students enrolled in an advanced curriculum development course at the University of Southern Mississippi (Hattiesburg). The students used a mock trial format to consider reasons to support establishment of a national curriculum (concerning the American public's…

  4. Nuclear test ban verification

    International Nuclear Information System (INIS)

    Chun, Kin-Yip

    1991-07-01

    This report describes verification and its rationale, the basic tasks of seismic verification, the physical basis for earthquake/explosion source discrimination and explosion yield determination, the technical problems pertaining to seismic monitoring of underground nuclear tests, the basic problem-solving strategy deployed by the forensic seismology resarch team at the University of Toronto, and the scientific significance of the team's research. The research carried out at the Univeristy of Toronto has two components: teleseismic verification using P wave recordings from the Yellowknife Seismic Array (YKA), and regional (close-in) verification using high-frequency L g and P n recordings from the Eastern Canada Telemetered Network. Major differences have been found in P was attenuation among the propagation paths connecting the YKA listening post with seven active nuclear explosion testing areas in the world. Significant revisions have been made to previously published P wave attenuation results, leading to more interpretable nuclear explosion source functions. (11 refs., 12 figs.)

  5. Reporting of clinical trials: a review of research funders' guidelines

    Directory of Open Access Journals (Sweden)

    Williamson Paula R

    2008-11-01

    Full Text Available Abstract Background Randomised controlled trials (RCTs represent the gold standard methodological design to evaluate the effectiveness of an intervention in humans but they are subject to bias, including study publication bias and outcome reporting bias. National and international organisations and charities give recommendations for good research practice in relation to RCTs but to date no review of these guidelines has been undertaken with respect to reporting bias. Methods National and international organisations and UK based charities listed on the Association for Medical Research Charities website were contacted in 2007; they were considered eligible for this review if they funded RCTs. Guidelines were obtained and assessed in relation to what was written about trial registration, protocol adherence and trial publication. It was also noted whether any monitoring against these guidelines was undertaken. This information was necessary to discover how much guidance researchers are given on the publication of results, in order to prevent study publication bias and outcome reporting bias. Results Seventeen organisations and 56 charities were eligible of 140 surveyed for this review, although there was no response from 12. Trial registration, protocol adherence, trial publication and monitoring against the guidelines were often explicitly discussed or implicitly referred too. However, only eleven of these organisations or charities mentioned the publication of negative as well as positive outcomes and just three of the organisations specifically stated that the statistical analysis plan should be strictly adhered to and all changes should be reported. Conclusion Our review indicates that there is a need to provide more detailed guidance for those conducting and reporting clinical trials to help prevent the selective reporting of results. Statements found in the guidelines generally refer to publication bias rather than outcome reporting bias

  6. Impact of radiation research on clinical trials in radiation oncology

    International Nuclear Information System (INIS)

    Rubin, P.; Van Ess, J.D.

    1989-01-01

    The authors present an outline review of the history of the formation of the cooperative group called International Clinical Trials in Radiation Oncology (ICTRO), and the following areas are briefly discussed together with some projections for the direction of clinical trials in radiation oncology into the 1990s:- radiosensitizers, radioprotectors, and their combination, drug-radiation interactions, dose/time/fractionation, hyperthermia, biological response modifiers and radiolabelled antibodies, high LET, particularly neutron therapy, large field irradiation and interoperative irradiation, research studies on specific sites. (U.K.)

  7. Qualitative Research in Palliative Care: Applications to Clinical Trials Work.

    Science.gov (United States)

    Lim, Christopher T; Tadmor, Avia; Fujisawa, Daisuke; MacDonald, James J; Gallagher, Emily R; Eusebio, Justin; Jackson, Vicki A; Temel, Jennifer S; Greer, Joseph A; Hagan, Teresa; Park, Elyse R

    2017-08-01

    While vast opportunities for using qualitative methods exist within palliative care research, few studies provide practical advice for researchers and clinicians as a roadmap to identify and utilize such opportunities. To provide palliative care clinicians and researchers descriptions of qualitative methodology applied to innovative research questions relative to palliative care research and define basic concepts in qualitative research. Body: We describe three qualitative projects as exemplars to describe major concepts in qualitative analysis of early palliative care: (1) a descriptive analysis of clinician documentation in the electronic health record, (2) a thematic content analysis of palliative care clinician focus groups, and (3) a framework analysis of audio-recorded encounters between patients and clinicians as part of a clinical trial. This study provides a foundation for undertaking qualitative research within palliative care and serves as a framework for use by other palliative care researchers interested in qualitative methodologies.

  8. Potential of adaptive clinical trial designs in pharmacogenetic research, A simulation based on the IPASS trial

    NARCIS (Netherlands)

    Van Der Baan, Frederieke H.; Knol, Mirjam J.|info:eu-repo/dai/nl/304820350; Klungel, Olaf H.|info:eu-repo/dai/nl/181447649; Egberts, Toine C.G.|info:eu-repo/dai/nl/162850050; Grobbee, Diederick E.; Roes, Kit C.B.

    2011-01-01

    Background: An adaptive clinical trial design that allows population enrichment after interim analysis can be advantageous in pharmacogenetic research if previous evidence is not strong enough to exclude part of the patient population beforehand.With this design, underpowered studies or unnecessary

  9. Modifying the Clinical Research Infrastructure at a Dedicated Clinical Trials Unit: Assessment of Trial Development, Activation, and Participant Accrual.

    Science.gov (United States)

    Tang, Chad; Hess, Kenneth R; Sanders, Dwana; Davis, Suzanne E; Buzdar, Aman U; Kurzrock, Razelle; Lee, J Jack; Meric-Bernstam, Funda; Hong, David S

    2017-03-15

    Purpose: Information on processes for trials assessing investigational therapeutics is sparse. We assessed the trial development processes within the Department of Investigational Cancer Therapeutics (ICT) at MD Anderson Cancer Center (Houston, TX) and analyzed their effects on the trial activation timeline and enrolment. Experimental Design: Data were from a prospectively maintained registry that tracks all clinical studies at MD Anderson. From this database, we identified 2,261 activated phase I-III trials; 221 were done at the ICT. ICT trials were matched to trials from other MD Anderson departments by phase, sponsorship, and submission year. Trial performance metrics were compared with paired Wilcoxon signed rank tests. Results: We identified three facets of the ICT research infrastructure: parallel processing of trial approval steps; a physician-led research team; and regular weekly meetings to foster research accountability. Separate analyses were conducted stratified by sponsorship [industry (133 ICT and 133 non-ICT trials) or institutional (68 ICT and 68 non-ICT trials)]. ICT trial development was faster from IRB approval to activation (median difference of 1.1 months for industry-sponsored trials vs. 2.3 months for institutional) and from activation to first enrolment (median difference of 0.3 months for industry vs. 1.2 months for institutional; all matched P infrastructure within a large academic cancer center was associated with efficient trial development and participant accrual. Clin Cancer Res; 23(6); 1407-13. ©2016 AACR . ©2016 American Association for Cancer Research.

  10. SUPERFUND TREATABILITY CLEARINGHOUSE: FULL SCALE ROTARY KILN INCINERATOR FIELD TRIAL: PHASE I, VERIFICATION TRIAL BURN ON DIOXIN/HERBICIDE ORANGE CONTAMINATED SOIL

    Science.gov (United States)

    This treatability study reports on the results of one of a series of field trials using various remedial action technologies that may be capable of restoring Herbicide Orange (HO)XDioxin contaminated sites. A full-scale field trial using a rotary kiln incinerator capable of pro...

  11. On-site verification trials using fly ash for reclamation behind bulkheads; Sekitanbai wo gogan uraumezai ni riyosuru genba jissho chosa

    Energy Technology Data Exchange (ETDEWEB)

    Kozawa, K [Center for Coal Utilization, Japan, Tokyo (Japan); Yoshida, T [Toyo Construction Co. Ltd., Tokyo (Japan); Miyagawa, H; Kobayashi, M

    1996-09-01

    As a method to utilize coal ash generated from coal burning power plants more effectively in bulk, its use has been studied as a reclamation material behind bulkhead structures in harbors and airports. Verification trials for the study results were performed at the Hekinan power plant of the Chubu Electric Power Company. The trials included the following: an experiment to verify horizontal soil pressure and active earth pressure when slurry made of fly ash added with cement and seawater was placed in frameworks installed behind bulkheads of a harbor, a slurry hardening test, environmental impact investigation, and constructibility investigation. As a result, a large number of findings were obtained, including the following matters: earth pressure of slurry which has been placed in a soil tank in about ten minutes would be measured as pressure of liquid, but it shifts to behavior as a soil in a relatively short time; the earth pressure after three hours agreed with static earth pressure calculated under provision of K{sub o} = 0.2; and a hardened body made with cement under a certain mixing ratio was obtained, which stands by itself at a height of 7.5 m at compression strength of 1.77 kgf/cm {sup 2}. 11 figs., 2 tabs.

  12. Digital pathology in nephrology clinical trials, research, and pathology practice.

    Science.gov (United States)

    Barisoni, Laura; Hodgin, Jeffrey B

    2017-11-01

    In this review, we will discuss (i) how the recent advancements in digital technology and computational engineering are currently applied to nephropathology in the setting of clinical research, trials, and practice; (ii) the benefits of the new digital environment; (iii) how recognizing its challenges provides opportunities for transformation; and (iv) nephropathology in the upcoming era of kidney precision and predictive medicine. Recent studies highlighted how new standardized protocols facilitate the harmonization of digital pathology database infrastructure and morphologic, morphometric, and computer-aided quantitative analyses. Digital pathology enables robust protocols for clinical trials and research, with the potential to identify previously underused or unrecognized clinically useful parameters. The integration of digital pathology with molecular signatures is leading the way to establishing clinically relevant morpho-omic taxonomies of renal diseases. The introduction of digital pathology in clinical research and trials, and the progressive implementation of the modern software ecosystem, opens opportunities for the development of new predictive diagnostic paradigms and computer-aided algorithms, transforming the practice of renal disease into a modern computational science.

  13. What Value Can Qualitative Research Add to Quantitative Research Design? An Example From an Adolescent Idiopathic Scoliosis Trial Feasibility Study.

    Science.gov (United States)

    Toye, Francine; Williamson, Esther; Williams, Mark A; Fairbank, Jeremy; Lamb, Sarah E

    2016-08-09

    Using an example of qualitative research embedded in a non-surgical feasibility trial, we explore the benefits of including qualitative research in trial design and reflect on epistemological challenges. We interviewed 18 trial participants and used methods of Interpretive Phenomenological Analysis. Our findings demonstrate that qualitative research can make a valuable contribution by allowing trial stakeholders to see things from alternative perspectives. Specifically, it can help to make specific recommendations for improved trial design, generate questions which contextualize findings, and also explore disease experience beyond the trial. To make the most out of qualitative research embedded in quantitative design it would be useful to (a) agree specific qualitative study aims that underpin research design, (b) understand the impact of differences in epistemological truth claims, (c) provide clear thematic interpretations for trial researchers to utilize, and (d) include qualitative findings that explore experience beyond the trial setting within the impact plan. © The Author(s) 2016.

  14. Multilateral disarmament verification

    International Nuclear Information System (INIS)

    Persbo, A.

    2013-01-01

    Non-governmental organisations, such as VERTIC (Verification Research, Training and Information Centre), can play an important role in the promotion of multilateral verification. Parties involved in negotiating nuclear arms accords are for the most part keen that such agreements include suitable and robust provisions for monitoring and verification. Generally progress in multilateral arms control verification is often painstakingly slow, but from time to time 'windows of opportunity' - that is, moments where ideas, technical feasibility and political interests are aligned at both domestic and international levels - may occur and we have to be ready, so the preparatory work is very important. In the context of nuclear disarmament, verification (whether bilateral or multilateral) entails an array of challenges, hurdles and potential pitfalls relating to national security, health, safety and even non-proliferation, so preparatory work is complex and time-greedy. A UK-Norway Initiative was established in order to investigate the role that a non-nuclear-weapon state such as Norway could potentially play in the field of nuclear arms control verification. (A.C.)

  15. Air Force Research Laboratory Test and Evaluation, Verification and Validation of Autonomous Systems Challenge Exploration

    Science.gov (United States)

    2014-11-13

    and produce the initial draft of the AFRL TEV&V storyboard and supporting research needs. This chapter highlights the key components of the storyboard ...Kris previewed  the  storyboard  that was created to tie the research portfolios to the AFRL Autonomy Strategy goal "Highly effective  Human‐Machine...AFRL may want to develop something like this for T&E, V&V. The  storyboard  can be found in Appendix A4, "Highly effective Human‐Machine Teaming

  16. Verification of Bayesian Clustering in Travel Behaviour Research – First Step to Macroanalysis of Travel Behaviour

    Science.gov (United States)

    Satra, P.; Carsky, J.

    2018-04-01

    Our research is looking at the travel behaviour from a macroscopic view, taking one municipality as a basic unit. The travel behaviour of one municipality as a whole is becoming one piece of a data in the research of travel behaviour of a larger area, perhaps a country. A data pre-processing is used to cluster the municipalities in groups, which show similarities in their travel behaviour. Such groups can be then researched for reasons of their prevailing pattern of travel behaviour without any distortion caused by municipalities with a different pattern. This paper deals with actual settings of the clustering process, which is based on Bayesian statistics, particularly the mixture model. An optimization of the settings parameters based on correlation of pointer model parameters and relative number of data in clusters is helpful, however not fully reliable method. Thus, method for graphic representation of clusters needs to be developed in order to check their quality. A training of the setting parameters in 2D has proven to be a beneficial method, because it allows visual control of the produced clusters. The clustering better be applied on separate groups of municipalities, where competition of only identical transport modes can be found.

  17. Scalable Techniques for Formal Verification

    CERN Document Server

    Ray, Sandip

    2010-01-01

    This book presents state-of-the-art approaches to formal verification techniques to seamlessly integrate different formal verification methods within a single logical foundation. It should benefit researchers and practitioners looking to get a broad overview of the spectrum of formal verification techniques, as well as approaches to combining such techniques within a single framework. Coverage includes a range of case studies showing how such combination is fruitful in developing a scalable verification methodology for industrial designs. This book outlines both theoretical and practical issue

  18. Physician participation in clinical research and trials: issues and approaches

    Directory of Open Access Journals (Sweden)

    Sami F Shaban

    2011-03-01

    research culture’. This article examines the barriers to and benefits of physician participation in clinical research as well as interventions needed to increase their participation, including the specific role of undergraduate medical education. The main challenge is the unwillingness of many physicians and patients to participate in clinical trials. Barriers to participation include lack of time, lack of resources, trial-specific issues, communication difficulties, conflicts between the role of clinician and scientist, inadequate research experience and training for physicians, lack of rewards and recognition for physicians, and sometimes a scientifically uninteresting research question, among others. Strategies to encourage physician participation in clinical research include financial and nonfinancial incentives, adequate training, research questions that are in line with physician interests and have clear potential to improve patient care, and regular feedback. Finally, encouraging research culture and fostering the development of inquiry and research-based learning among medical students is now a high priority in order to develop more and better clinician-researchers.Keywords: physician, clinical research, clinical trial, medical education

  19. Research on Digital Output Verification Technology of Electronic DC Current Transformer

    Science.gov (United States)

    Chen, Yuanjie; Wang, Bin; Hu, Haoliang; Xiong, Qianzhu; Yang, Chunyan

    2017-05-01

    Aiming at the error of calibration system when conducting field calibration by electronic DC current transformer’s digital calibration system, an electronic DC current transformer’s digital calibration system based on protocol conversion is proposed and researched. Data frames outputted from merging unit are collected and converted by the system, the digital synchronization is realized by using the synchronous clock device to trigger the second pulse, and it is verified by the virtual instrument design software. The field calibration is conducted to some converter station digital dc current transformer under the rated current of 500A by using the calibration system. By calibrating and analyzing errors, the error is less than 0.075% when tested current is more than 40% of the rated current. According the standard in literature[1], performance of the calibration system is perfect, measured results perfectly meet the requirements of design, and the calibration system has great practical application value.

  20. Verification of radioactive contamination surveys for practical use in biological research centres

    International Nuclear Information System (INIS)

    Macias, M.T.; Requejo, C.; Ruiz, M.; Pina, R.

    2006-01-01

    Unsealed sources are commonly used in science research laboratories. Their manipulation may imply a radioactive contamination hazard. Therefore, adequate and sensitive survey meters must be available, and must have an effective and accurate response to intensity and type of radiation emitted by the used radionuclides to identify and quantify the possible contamination and then be able to avoid any associated or unwanted consequences that may arise. Periodic surveys are performed to show control, any time, any place radioactive contamination is suspected, and to ensure radioisotopes are being used safely. The immediate work areas must be often checked with portable survey monitors, including the entire lab and particularly bench tops, personnel protective equipment or solely designated equipment for isotope use (micro-fuges, water baths, incubators). These are carried out with portable survey instruments like Geiger-Muller tubes, proportional counters and scintillation detectors that provide direct or indirect measurements capabilities. The Radiation Safety Office (R.S.O.) as well as the radioactive compounds working laboratories at the Instituto de Inv. Biomedicas 'A. Sols' (Madrid-Spain) are provided with an adequate radiation measurement instrument. But, before a portable survey instrument is used, several quality checks should be made (batteries, calibration sticker), and the instrument response should be tested with a check source. This paper aims at determining, with a R.S.O. procedure, these surveys working parameters -detection efficiency, calibration factors and minimum detectable activities-, using reference checking sources ( 14 C, 36 Cl, and 90 Sr/ 90 Y) with known radioactivity covering the energy range of beta emitting isotopes used in biological research. No gamma portable monitors have been tested for the R.S.O. has no gamma checking sources. Therefore, 58 beta monitors were tested, obtaining t he efficiency values, the calibration factors (Bq cm-2 s

  1. Verification and characterization of continuum behavior of fractured rock at AECL Underground Research Laboratory

    International Nuclear Information System (INIS)

    Long, J.C.S.

    1985-02-01

    The purposes of this study are to determine when a fracture system behaves as a porous medium and what the corresponding permeability tensor is. A two-dimensional fracture system model is developed with density, size, orientation, and location of fractures in an impermeable matrix as random variables. Simulated flow tests through the models measure directional permeability, K/sub g/. Polar coordinate plots of 1/√K/sub g/, which are ellipses for equivalent anistropic homogeneous porous media, are graphed and best fit ellipses are calculated. Fracture length and areal density were varied such that fracture frequency was held constant. The examples showed the permeability increased with fracture length. The modeling techniques were applied to data from the Atomic Energy of Canada Ltd.'s Underground Research Laboratory facility in Manitoba, Canada by assuming the fracture pattern at the surface persists at depth. Well test data were used to estimate the aperture distribution by both correlating and not correlating the aperture with fracture length. The permeability of models with uncorrelated length and aperture were smaller than those for correlated models. A Monte Carlo type study showed that analysis of steady state packer tests consistently underestimate the mean aperture. Finally, a three-dimensional model in which fractures are discs randomly located in space, interactions between the fractures are line segments, and the solution of the steady state flow equations is based on image theory was discussed

  2. What can qualitative research do for randomised controlled trials? A systematic mapping review

    Science.gov (United States)

    O'Cathain, A; Thomas, K J; Drabble, S J; Rudolph, A; Hewison, J

    2013-01-01

    Objective To develop an empirically based framework of the aspects of randomised controlled trials addressed by qualitative research. Design Systematic mapping review of qualitative research undertaken with randomised controlled trials and published in peer-reviewed journals. Data sources MEDLINE, PreMEDLINE, EMBASE, the Cochrane Library, Health Technology Assessment, PsycINFO, CINAHL, British Nursing Index, Social Sciences Citation Index and ASSIA. Eligibility criteria Articles reporting qualitative research undertaken with trials published between 2008 and September 2010; health research, reported in English. Results 296 articles met the inclusion criteria. Articles focused on 22 aspects of the trial within five broad categories. Some articles focused on more than one aspect of the trial, totalling 356 examples. The qualitative research focused on the intervention being trialled (71%, 254/356); the design, process and conduct of the trial (15%, 54/356); the outcomes of the trial (1%, 5/356); the measures used in the trial (3%, 10/356); and the target condition for the trial (9%, 33/356). A minority of the qualitative research was undertaken at the pretrial stage (28%, 82/296). The value of the qualitative research to the trial itself was not always made explicit within the articles. The potential value included optimising the intervention and trial conduct, facilitating interpretation of the trial findings, helping trialists to be sensitive to the human beings involved in trials, and saving money by steering researchers towards interventions more likely to be effective in future trials. Conclusions A large amount of qualitative research undertaken with specific trials has been published, addressing a wide range of aspects of trials, with the potential to improve the endeavour of generating evidence of effectiveness of health interventions. Researchers can increase the impact of this work on trials by undertaking more of it at the pretrial stage and being explicit

  3. Research ethics board approval for an international thromboprophylaxis trial.

    Science.gov (United States)

    Lutz, Kristina; Wilton, Kelly; Zytaruk, Nicole; Julien, Lisa; Hall, Richard; Harvey, Johanne; Skrobik, Yoanna; Vlahakis, Nicholas; Meade, Laurie; Matte, Andrea; Meade, Maureen; Burns, Karen; Albert, Martin; Cash, Bronwyn Barlow; Vallance, Shirley; Klinger, James; Heels-Ansdell, Diane; Cook, Deborah

    2012-06-01

    Research ethics board (REB) review of scientific protocols is essential, ensuring participants' dignity, safety, and rights. The objectives of this study were to examine the time from submission to approval, to analyze predictors of approval time, and to describe the scope of conditions from REBs evaluating an international thromboprophylaxis trial. We generated survey items through literature review and investigators' discussions, creating 4 domains: respondent and institutional demographics, the REB application process, and alternate consent models. We conducted a document analysis that involved duplicate assessment of themes from REB critique of the protocol and informed consent forms (ICF). Approval was granted from 65 REB institutions, requiring 58 unique applications. We analyzed 44 (75.9%) of 58 documents and surveys. Survey respondents completing the applications had 8 (5-12) years of experience; 77% completed 4 or more REB applications in previous 5 years. Critical care personnel were represented on 54% of REBs. The time to approval was a median (interquartile range) of 75 (42, 150) days, taking longer for sites with national research consortium membership (89.1 vs 31.0 days, P = .03). Document analysis of the application process and ICF yielded 5 themes: methodology, data management, consent procedures, cataloguing, and miscellaneous. Protocol-specific themes focused on trial implementation, external critiques, and budget. The only theme specific to the ICF was risks and benefits. The most frequent comments on the protocol and ICF were about methodology and miscellaneous issues; ICF comments also addressed study risks and benefits. More studies on methods to enhance efficiency and consistency of the REB approval processes for clinical trials are needed while still maintaining high ethical standards. Copyright © 2012 Elsevier Inc. All rights reserved.

  4. Biased and inadequate citation of prior research in reports of cardiovascular trials is a continuing source of waste in research.

    Science.gov (United States)

    Sawin, Veronica I; Robinson, Karen A

    2016-01-01

    We assessed citation of prior research over time and the association of citation with the agreement of results between the trial being reported and the prior trial. Groups of pharmacologic trials in cardiovascular disease were created using meta-analyses, and we assessed citation within these groups. We calculated the proportion of prior trials cited, the proportion of study participants captured in citations, and agreement of results between citing and cited trials. Analysis included 86 meta-analyses with 580 trials published between 1982 and 2011. Reports of trials cited 25% (median; 95% confidence interval [CI], 23-27%) of prior trials, capturing 31% (95% CI, 25-36%) of trial participants. Neither measure differed by publication of the citing trial before vs. after 2005. Prior trials with results that agreed with the reports of trials (supportive trials) were significantly more likely to be cited than nonsupportive trials (relative risk 1.45; 95% CI, 1.30-1.61, P < 0.001). Selective undercitation of prior research continues; three quarters of existing evidence is ignored. This source of waste may result in unnecessary, unethical, and unscientific studies. Copyright © 2016 Elsevier Inc. All rights reserved.

  5. Prostate Cancer Research Trial Helps John Spencer Treat His Cancer | NIH MedlinePlus the Magazine

    Science.gov (United States)

    ... of this page please turn Javascript on. Feature: Prostate Cancer Prostate Cancer Research Trial Helps John Spencer Treat His Cancer ... because of timely detection and treatment of his prostate cancer. He participated in an NIH-sponsored clinical trial. ...

  6. Getting added value from using qualitative research with randomized controlled trials: a qualitative interview study

    Science.gov (United States)

    2014-01-01

    Background Qualitative research is undertaken with randomized controlled trials of health interventions. Our aim was to explore the perceptions of researchers with experience of this endeavour to understand the added value of qualitative research to the trial in practice. Methods A telephone semi-structured interview study with 18 researchers with experience of undertaking the trial and/or the qualitative research. Results Interviewees described the added value of qualitative research for the trial, explaining how it solved problems at the pretrial stage, explained findings, and helped to increase the utility of the evidence generated by the trial. From the interviews, we identified three models of relationship of the qualitative research to the trial. In ‘the peripheral’ model, the trial was an opportunity to undertake qualitative research, with no intention that it would add value to the trial. In ‘the add-on’ model, the qualitative researcher understood the potential value of the qualitative research but it was viewed as a separate and complementary endeavour by the trial lead investigator and wider team. Interviewees described how this could limit the value of the qualitative research to the trial. Finally ‘the integral’ model played out in two ways. In ‘integral-in-theory’ studies, the lead investigator viewed the qualitative research as essential to the trial. However, in practice the qualitative research was under-resourced relative to the trial, potentially limiting its ability to add value to the trial. In ‘integral-in-practice’ studies, interviewees described how the qualitative research was planned from the beginning of the study, senior qualitative expertise was on the team from beginning to end, and staff and time were dedicated to the qualitative research. In these studies interviewees described the qualitative research adding value to the trial although this value was not necessarily visible beyond the original research team due

  7. Getting added value from using qualitative research with randomized controlled trials: a qualitative interview study.

    Science.gov (United States)

    O'Cathain, Alicia; Goode, Jackie; Drabble, Sarah J; Thomas, Kate J; Rudolph, Anne; Hewison, Jenny

    2014-06-09

    Qualitative research is undertaken with randomized controlled trials of health interventions. Our aim was to explore the perceptions of researchers with experience of this endeavour to understand the added value of qualitative research to the trial in practice. A telephone semi-structured interview study with 18 researchers with experience of undertaking the trial and/or the qualitative research. Interviewees described the added value of qualitative research for the trial, explaining how it solved problems at the pretrial stage, explained findings, and helped to increase the utility of the evidence generated by the trial. From the interviews, we identified three models of relationship of the qualitative research to the trial. In 'the peripheral' model, the trial was an opportunity to undertake qualitative research, with no intention that it would add value to the trial. In 'the add-on' model, the qualitative researcher understood the potential value of the qualitative research but it was viewed as a separate and complementary endeavour by the trial lead investigator and wider team. Interviewees described how this could limit the value of the qualitative research to the trial. Finally 'the integral' model played out in two ways. In 'integral-in-theory' studies, the lead investigator viewed the qualitative research as essential to the trial. However, in practice the qualitative research was under-resourced relative to the trial, potentially limiting its ability to add value to the trial. In 'integral-in-practice' studies, interviewees described how the qualitative research was planned from the beginning of the study, senior qualitative expertise was on the team from beginning to end, and staff and time were dedicated to the qualitative research. In these studies interviewees described the qualitative research adding value to the trial although this value was not necessarily visible beyond the original research team due to the challenges of publishing this research

  8. HDL to verification logic translator

    Science.gov (United States)

    Gambles, J. W.; Windley, P. J.

    1992-01-01

    The increasingly higher number of transistors possible in VLSI circuits compounds the difficulty in insuring correct designs. As the number of possible test cases required to exhaustively simulate a circuit design explodes, a better method is required to confirm the absence of design faults. Formal verification methods provide a way to prove, using logic, that a circuit structure correctly implements its specification. Before verification is accepted by VLSI design engineers, the stand alone verification tools that are in use in the research community must be integrated with the CAD tools used by the designers. One problem facing the acceptance of formal verification into circuit design methodology is that the structural circuit descriptions used by the designers are not appropriate for verification work and those required for verification lack some of the features needed for design. We offer a solution to this dilemma: an automatic translation from the designers' HDL models into definitions for the higher-ordered logic (HOL) verification system. The translated definitions become the low level basis of circuit verification which in turn increases the designer's confidence in the correctness of higher level behavioral models.

  9. Assessing Clinical Trial-Associated Workload in Community-Based Research Programs Using the ASCO Clinical Trial Workload Assessment Tool.

    Science.gov (United States)

    Good, Marjorie J; Hurley, Patricia; Woo, Kaitlin M; Szczepanek, Connie; Stewart, Teresa; Robert, Nicholas; Lyss, Alan; Gönen, Mithat; Lilenbaum, Rogerio

    2016-05-01

    Clinical research program managers are regularly faced with the quandary of determining how much of a workload research staff members can manage while they balance clinical practice and still achieve clinical trial accrual goals, maintain data quality and protocol compliance, and stay within budget. A tool was developed to measure clinical trial-associated workload, to apply objective metrics toward documentation of work, and to provide clearer insight to better meet clinical research program challenges and aid in balancing staff workloads. A project was conducted to assess the feasibility and utility of using this tool in diverse research settings. Community-based research programs were recruited to collect and enter clinical trial-associated monthly workload data into a web-based tool for 6 consecutive months. Descriptive statistics were computed for self-reported program characteristics and workload data, including staff acuity scores and number of patient encounters. Fifty-one research programs that represented 30 states participated. Median staff acuity scores were highest for staff with patients enrolled in studies and receiving treatment, relative to staff with patients in follow-up status. Treatment trials typically resulted in higher median staff acuity, relative to cancer control, observational/registry, and prevention trials. Industry trials exhibited higher median staff acuity scores than trials sponsored by the National Institutes of Health/National Cancer Institute, academic institutions, or others. The results from this project demonstrate that trial-specific acuity measurement is a better measure of workload than simply counting the number of patients. The tool was shown to be feasible and useable in diverse community-based research settings. Copyright © 2016 by American Society of Clinical Oncology.

  10. The End-To-End Safety Verification Process Implemented to Ensure Safe Operations of the Columbus Research Module

    Science.gov (United States)

    Arndt, J.; Kreimer, J.

    2010-09-01

    The European Space Laboratory COLUMBUS was launched in February 2008 with NASA Space Shuttle Atlantis. Since successful docking and activation this manned laboratory forms part of the International Space Station(ISS). Depending on the objectives of the Mission Increments the on-orbit configuration of the COLUMBUS Module varies with each increment. This paper describes the end-to-end verification which has been implemented to ensure safe operations under the condition of a changing on-orbit configuration. That verification process has to cover not only the configuration changes as foreseen by the Mission Increment planning but also those configuration changes on short notice which become necessary due to near real-time requests initiated by crew or Flight Control, and changes - most challenging since unpredictable - due to on-orbit anomalies. Subject of the safety verification is on one hand the on orbit configuration itself including the hardware and software products, on the other hand the related Ground facilities needed for commanding of and communication to the on-orbit System. But also the operational products, e.g. the procedures prepared for crew and ground control in accordance to increment planning, are subject of the overall safety verification. In order to analyse the on-orbit configuration for potential hazards and to verify the implementation of the related Safety required hazard controls, a hierarchical approach is applied. The key element of the analytical safety integration of the whole COLUMBUS Payload Complement including hardware owned by International Partners is the Integrated Experiment Hazard Assessment(IEHA). The IEHA especially identifies those hazardous scenarios which could potentially arise through physical and operational interaction of experiments. A major challenge is the implementation of a Safety process which owns quite some rigidity in order to provide reliable verification of on-board Safety and which likewise provides enough

  11. Who is the research subject in cluster randomized trials in health research?

    Directory of Open Access Journals (Sweden)

    Brehaut Jamie C

    2011-07-01

    Full Text Available Abstract This article is part of a series of papers examining ethical issues in cluster randomized trials (CRTs in health research. In the introductory paper in this series, we set out six areas of inquiry that must be addressed if the CRT is to be set on a firm ethical foundation. This paper addresses the first of the questions posed, namely, who is the research subject in a CRT in health research? The identification of human research subjects is logically prior to the application of protections as set out in research ethics and regulation. Aspects of CRT design, including the fact that in a single study the units of randomization, experimentation, and observation may differ, complicate the identification of human research subjects. But the proper identification of human research subjects is important if they are to be protected from harm and exploitation, and if research ethics committees are to review CRTs efficiently. We examine the research ethics literature and international regulations to identify the core features of human research subjects, and then unify these features under a single, comprehensive definition of human research subject. We define a human research subject as any person whose interests may be compromised as a result of interventions in a research study. Individuals are only human research subjects in CRTs if: (1 they are directly intervened upon by investigators; (2 they interact with investigators; (3 they are deliberately intervened upon via a manipulation of their environment that may compromise their interests; or (4 their identifiable private information is used to generate data. Individuals who are indirectly affected by CRT study interventions, including patients of healthcare providers participating in knowledge translation CRTs, are not human research subjects unless at least one of these conditions is met.

  12. Brain Tumor Trials Collaborative | Center for Cancer Research

    Science.gov (United States)

    Brain Tumor Trials Collaborative In Pursuit of a Cure The mission of the BTTC is to develop and perform state-of-the-art clinical trials in a collaborative and collegial environment, advancing treatments for patients with brain tumors, merging good scientific method with concern for patient well-being and outcome.

  13. Evaluating the design and reporting of pragmatic trials in osteoarthritis research.

    Science.gov (United States)

    Ali, Shabana Amanda; Kloseck, Marita; Lee, Karen; Walsh, Kathleen Ellen; MacDermid, Joy C; Fitzsimmons, Deborah

    2018-01-01

    Among the challenges in health research is translating interventions from controlled experimental settings to clinical and community settings where chronic disease is managed daily. Pragmatic trials offer a method for testing interventions in real-world settings but are seldom used in OA research. The aim of this study was to evaluate the literature on pragmatic trials in OA research up to August 2016 in order to identify strengths and weaknesses in the design and reporting of these trials. We used established guidelines to assess the degree to which 61 OA studies complied with pragmatic trial design and reporting. We assessed design according to the pragmatic-explanatory continuum indicator summary and reporting according to the pragmatic trials extension of the CONsolidated Standards of Reporting Trials guidelines. None of the pragmatic trials met all 11 criteria evaluated and most of the trials met between 5 and 8 of the criteria. Criteria most often unmet pertained to practitioner expertise (by requiring specialists) and criteria most often met pertained to primary outcome analysis (by using intention-to-treat analysis). Our results suggest a lack of highly pragmatic trials in OA research. We identify this as a point of opportunity to improve research translation, since optimizing the design and reporting of pragmatic trials can facilitate implementation of evidence-based interventions for OA care. © The Author 2017. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For Permissions, please email: journals.permissions@oup.com

  14. [An Investigation of the Role Responsibilities of Clinical Research Nurses in Conducting Clinical Trials].

    Science.gov (United States)

    Kao, Chi-Yin; Huang, Guey-Shiun; Dai, Yu-Tzu; Pai, Ya-Ying; Hu, Wen-Yu

    2015-06-01

    Clinical research nurses (CRNs) play an important role in improving the quality of clinical trials. In Taiwan, the increasing number of clinical trials has increased the number of practicing CRNs. Understanding the role responsibilities of CRNs is necessary to promote professionalism in this nursing category. This study investigates the role responsibilities of CRNs in conducting clinical trials / research. A questionnaire survey was conducted in a medical center in Taipei City, Taiwan. Eighty CRNs that were registered to facilitate and conduct clinical trials at this research site completed the survey. "Subject protection" was the CRN role responsibility most recognized by participants, followed by "research coordination and management", "subject clinical care", and "advanced professional nursing". Higher recognition scores were associated with higher importance scores and lower difficulty scores. Participants with trial training had significantly higher difficulty scores for "subject clinical care" and "research coordination and management" than their peers without this training (p research coordination and management" (p clinical practice.

  15. Improved verification methods for safeguards verifications at enrichment plants

    International Nuclear Information System (INIS)

    Lebrun, A.; Kane, S. C.; Bourva, L.; Poirier, S.; Loghin, N. E.; Langlands, D.

    2009-01-01

    The International Atomic Energy Agency (IAEA) has initiated a coordinated research and development programme to improve its verification methods and equipment applicable to enrichment plants. The programme entails several individual projects to meet the objectives of the IAEA Safeguards Model Approach for Gas Centrifuge Enrichment Plants updated in 2006. Upgrades of verification methods to confirm the absence of HEU (highly enriched uranium) production have been initiated and, in particular, the Cascade Header Enrichment Monitor (CHEM) has been redesigned to reduce its weight and incorporate an electrically cooled germanium detector. Such detectors are also introduced to improve the attended verification of UF 6 cylinders for the verification of the material balance. Data sharing of authenticated operator weighing systems such as accountancy scales and process load cells is also investigated as a cost efficient and an effective safeguards measure combined with unannounced inspections, surveillance and non-destructive assay (NDA) measurement. (authors)

  16. Improved verification methods for safeguards verifications at enrichment plants

    Energy Technology Data Exchange (ETDEWEB)

    Lebrun, A.; Kane, S. C.; Bourva, L.; Poirier, S.; Loghin, N. E.; Langlands, D. [Department of Safeguards, International Atomic Energy Agency, Wagramer Strasse 5, A1400 Vienna (Austria)

    2009-07-01

    The International Atomic Energy Agency (IAEA) has initiated a coordinated research and development programme to improve its verification methods and equipment applicable to enrichment plants. The programme entails several individual projects to meet the objectives of the IAEA Safeguards Model Approach for Gas Centrifuge Enrichment Plants updated in 2006. Upgrades of verification methods to confirm the absence of HEU (highly enriched uranium) production have been initiated and, in particular, the Cascade Header Enrichment Monitor (CHEM) has been redesigned to reduce its weight and incorporate an electrically cooled germanium detector. Such detectors are also introduced to improve the attended verification of UF{sub 6} cylinders for the verification of the material balance. Data sharing of authenticated operator weighing systems such as accountancy scales and process load cells is also investigated as a cost efficient and an effective safeguards measure combined with unannounced inspections, surveillance and non-destructive assay (NDA) measurement. (authors)

  17. Asthma: NIH-Sponsored Research and Clinical Trials | NIH MedlinePlus the Magazine

    Science.gov (United States)

    ... of this page please turn Javascript on. Feature: Asthma Asthma: NIH-Sponsored Research and Clinical Trials Past Issues / Fall 2011 Table of Contents NIH-Sponsored Research Asthma in the Inner City: Recognizing that asthma severity ...

  18. Laboratory research at the clinical trials of Veterinary medicinal Products

    OpenAIRE

    ZHYLA M.I.

    2011-01-01

    The article analyses the importance of laboratory test methods, namely pathomorfological at conduct of clinical trials. The article focuses on complex laboratory diagnostics at determination of clinical condition of animals, safety and efficacy of tested medicinal product.

  19. When ethics constrains clinical research: trial design of control arms in "greater than minimal risk" pediatric trials.

    Science.gov (United States)

    de Melo-Martín, Inmaculada; Sondhi, Dolan; Crystal, Ronald G

    2011-09-01

    For more than three decades clinical research in the United States has been explicitly guided by the idea that ethical considerations must be central to research design and practice. In spite of the centrality of this idea, attempting to balance the sometimes conflicting values of advancing scientific knowledge and protecting human subjects continues to pose challenges. Possible conflicts between the standards of scientific research and those of ethics are particularly salient in relation to trial design. Specifically, the choice of a control arm is an aspect of trial design in which ethical and scientific issues are deeply entwined. Although ethical quandaries related to the choice of control arms may arise when conducting any type of clinical trials, they are conspicuous in early phase gene transfer trials that involve highly novel approaches and surgical procedures and have children as the research subjects. Because of children's and their parents' vulnerabilities, in trials that investigate therapies for fatal, rare diseases affecting minors, the scientific and ethical concerns related to choosing appropriate controls are particularly significant. In this paper we use direct gene transfer to the central nervous system to treat late infantile neuronal ceroid lipofuscinosis to illustrate some of these ethical issues and explore possible solutions to real and apparent conflicts between scientific and ethical considerations.

  20. Clinical Trials

    Medline Plus

    Full Text Available ... Clinical Trials About Clinical Trials Clinical trials are research studies that explore whether a medical strategy, treatment, or ... humans. What Are Clinical Trials? Clinical trials are research studies that explore whether a medical strategy, treatment, or ...

  1. Research on non-uniform strain profile reconstruction along fiber Bragg grating via genetic programming algorithm and interrelated experimental verification

    Science.gov (United States)

    Zheng, Shijie; Zhang, Nan; Xia, Yanjun; Wang, Hongtao

    2014-03-01

    A new heuristic strategy for the non-uniform strain profile reconstruction along Fiber Bragg Gratings is proposed in this paper, which is based on the modified transfer matrix and Genetic Programming(GP) algorithm. The present method uses Genetic Programming to determine the applied strain field as a function of position along the fiber length. The structures that undergo adaptation in genetic programming are hierarchical structures which are different from that of conventional genetic algorithm operating on strings. GP regress the strain profile function which matches the 'measured' spectrum best and makes space resolution of strain reconstruction arbitrarily high, or even infinite. This paper also presents an experimental verification of the reconstruction of non-homogeneous strain fields using GP. The results are compared with numerical calculations of finite element method. Both the simulation examples and experimental results demonstrate that Genetic Programming can effectively reconstruct continuous profile expression along the whole FBG, and greatly improves its computational efficiency and accuracy.

  2. Swarm Verification

    Science.gov (United States)

    Holzmann, Gerard J.; Joshi, Rajeev; Groce, Alex

    2008-01-01

    Reportedly, supercomputer designer Seymour Cray once said that he would sooner use two strong oxen to plow a field than a thousand chickens. Although this is undoubtedly wise when it comes to plowing a field, it is not so clear for other types of tasks. Model checking problems are of the proverbial "search the needle in a haystack" type. Such problems can often be parallelized easily. Alas, none of the usual divide and conquer methods can be used to parallelize the working of a model checker. Given that it has become easier than ever to gain access to large numbers of computers to perform even routine tasks it is becoming more and more attractive to find alternate ways to use these resources to speed up model checking tasks. This paper describes one such method, called swarm verification.

  3. A research on the verification of models used in the computational codes and the uncertainty reduction method for the containment integrity evaluation

    Energy Technology Data Exchange (ETDEWEB)

    Kim, Moo Hwan; Seo, Kyoung Woo [POSTECH, Pohang (Korea, Republic of)

    2001-03-15

    In the probability approach, the calculated CCFPs of all the scenarios were zero, which meant that it was expected that for all the accident scenarios the maximum pressure load induced by DCH was lower than the containment failure pressure obtained from the fragility curve. Thus, it can be stated that the KSNP containment is robust to the DCH threat. And uncertainty of computer codes used to be two (deterministic and probabilistic) approaches were reduced by the sensitivity tests and the research with the verification and comparison of the DCH models in each code. So, this research was to evaluate synthetic result of DCH issue and expose accurate methodology to assess containment integrity about operating PWR in Korea.

  4. Practical and conceptual issues of clinical trial registration for Brazilian researchers

    Directory of Open Access Journals (Sweden)

    Carolina Gomes Freitas

    Full Text Available CONTEXT AND OBJECTIVE: Clinical trial registration is a prerequisite for publication in respected scientific journals. Recent Brazilian regulations also require registration of some clinical trials in the Brazilian Clinical Trials Registry (ReBEC but there is little information available about practical issues involved in the registration process. This article discusses the importance of clinical trial registration and the practical issues involved in this process. DESIGN AND SETTING: Descriptive study conducted by researchers within a postgraduate program at a public university in São Paulo, Brazil. METHODS: Information was obtained from clinical trial registry platforms, article reference lists and websites (last search: September 2014 on the following topics: definition of a clinical trial, history, purpose and importance of registry platforms, the information that should be registered and the registration process. RESULTS: Clinical trial registration aims to avoid publication bias and is required by Brazilian journals indexed in LILACS and SciELO and by journals affiliated to the International Committee of Medical Journal Editors (ICMJE. Recent Brazilian regulations require that all clinical trials (phases I to IV involving new drugs to be marketed in this country must be registered in ReBEC. The pros and cons of using different clinical trial registration platforms are discussed. CONCLUSIONS: Clinical trial registration is important and various mechanisms to enforce its implementation now exist. Researchers should take into account national regulations and publication requirements when choosing the platform on which they will register their trial.

  5. Describing qualitative research undertaken with randomised controlled trials in grant proposals: a documentary analysis.

    Science.gov (United States)

    Drabble, Sarah J; O'Cathain, Alicia; Thomas, Kate J; Rudolph, Anne; Hewison, Jenny

    2014-02-18

    There is growing recognition of the value of conducting qualitative research with trials in health research. It is timely to reflect on how this qualitative research is presented in grant proposals to identify lessons for researchers and research commissioners. As part of a larger study focusing on how to maximise the value of undertaking qualitative research with trials, we undertook a documentary analysis of proposals of funded studies. Using the metaRegister of Controlled Trials (mRCT) database we identified trials funded in the United Kingdom, ongoing between 2001 and 2010, and reporting the use of qualitative research. We requested copies of proposals from lead researchers. We extracted data from the proposals using closed and open questions, analysed using descriptive statistics and content analysis respectively. 2% (89/3812) of trials in the mRCT database described the use of qualitative research undertaken with the trial. From these 89 trials, we received copies of 36 full proposals, of which 32 met our inclusion criteria. 25% used less than a single paragraph to describe the qualitative research. The aims of the qualitative research described in these proposals focused mainly on the intervention or trial conduct. Just over half (56%) of the proposals included an explicit rationale for conducting the qualitative research with the trial, the most frequent being to optimise implementation into clinical practice or to interpret trial findings. Key information about methods, expertise and resources was missing in a large minority of proposals, in particular sample size, type of analysis, and non-personnel resources. 28% specifically stated that qualitative researchers would conduct the qualitative research. Our review of proposals of successfully funded studies identified good practice but also identified limited space given to describing the qualitative research, with an associated lack of attention to the rationale for doing the qualitative research and

  6. Describing qualitative research undertaken with randomised controlled trials in grant proposals: a documentary analysis

    Science.gov (United States)

    2014-01-01

    Background There is growing recognition of the value of conducting qualitative research with trials in health research. It is timely to reflect on how this qualitative research is presented in grant proposals to identify lessons for researchers and research commissioners. As part of a larger study focusing on how to maximise the value of undertaking qualitative research with trials, we undertook a documentary analysis of proposals of funded studies. Methods Using the metaRegister of Controlled Trials (mRCT) database we identified trials funded in the United Kingdom, ongoing between 2001 and 2010, and reporting the use of qualitative research. We requested copies of proposals from lead researchers. We extracted data from the proposals using closed and open questions, analysed using descriptive statistics and content analysis respectively. Results 2% (89/3812) of trials in the mRCT database described the use of qualitative research undertaken with the trial. From these 89 trials, we received copies of 36 full proposals, of which 32 met our inclusion criteria. 25% used less than a single paragraph to describe the qualitative research. The aims of the qualitative research described in these proposals focused mainly on the intervention or trial conduct. Just over half (56%) of the proposals included an explicit rationale for conducting the qualitative research with the trial, the most frequent being to optimise implementation into clinical practice or to interpret trial findings. Key information about methods, expertise and resources was missing in a large minority of proposals, in particular sample size, type of analysis, and non-personnel resources. 28% specifically stated that qualitative researchers would conduct the qualitative research. Conclusions Our review of proposals of successfully funded studies identified good practice but also identified limited space given to describing the qualitative research, with an associated lack of attention to the rationale for

  7. Influences on visit retention in clinical trials: insights from qualitative research during the VOICE trial in Johannesburg, South Africa.

    Science.gov (United States)

    Magazi, Busisiwe; Stadler, Jonathan; Delany-Moretlwe, Sinead; Montgomery, Elizabeth; Mathebula, Florence; Hartmann, Miriam; van der Straten, Ariane

    2014-07-28

    Although significant progress has been made in clinical trials of women-controlled methods of HIV prevention such as microbicides and Pre-exposure Prophylaxis (PrEP), low adherence to experimental study products remains a major obstacle to being able to establish their efficacy in preventing HIV infection. One factor that influences adherence is the ability of trial participants to attend regular clinic visits at which trial products are dispensed, adherence counseling is administered, and participant safety is monitored. We conducted a qualitative study of the social contextual factors that influenced adherence in the VOICE (MTN-003) trial in Johannesburg, South Africa, focusing on study participation in general, and study visits in particular. The research used qualitative methodologies, including in-depth interviews (IDI), serial ethnographic interviews (EI), and focus group discussions (FGD) among a random sub-sample of 102 female trial participants, 18 to 40 years of age. A socio-ecological framework that explored those factors that shaped trial participation and adherence to study products, guided the analysis. Key codes were developed to standardize subsequent coding and a node search was used to identify texts relating to obstacles to visit adherence. Our analysis includes coded transcripts from seven FGD (N = 40), 41 IDI, and 64 serial EI (N = 21 women). Women's kinship, social, and economic roles shaped their ability to participate in the clinical trial. Although participants expressed strong commitments to attend study visits, clinic visit schedules and lengthy waiting times interfered with their multiple obligations as care givers, wage earners, housekeepers, and students. The research findings highlight the importance of the social context in shaping participation in HIV prevention trials, beyond focusing solely on individual characteristics. This points to the need to focus interventions to improve visit attendance by promoting a culture of

  8. The UK clinical research network--has it been a success for dermatology clinical trials?

    Science.gov (United States)

    Thomas, Kim S; Koller, Karin; Foster, Katharine; Perdue, Jo; Charlesworth, Lisa; Chalmers, Joanne R

    2011-06-16

    Following the successful introduction of five topic-specific research networks in the UK, the Comprehensive Local Research Network (CLRN) was established in 2008 in order to provide a blanket level of support across the whole country regardless of the clinical discipline. The role of the CLRN was to facilitate recruitment into clinical trials, and to encourage greater engagement in research throughout the National Health Service (NHS). This report evaluates the impact of clinical research networks in supporting clinical trials in the UK, with particular reference to our experiences from two non-commercial dermatology trials. It covers our experience of engaging with the CLRN (and other research networks) using two non-commercial dermatology trials as case studies. We present the circumstances that led to our approach to the research networks for support, and the impact that this support had on the delivery of these trials. In both cases, recruitment was boosted considerably following the provision of additional support, although other factors such as the availability of experienced personnel, and the role of advertising and media coverage in promoting the trials were also important in translating this additional resource into increased recruitment. Recruitment into clinical trials is a complex task that can be influenced by many factors. A world-class clinical research infrastructure is now in place in England (with similar support available in Scotland and Wales), and it is the responsibility of the research community to ensure that this unique resource is used effectively and responsibly.

  9. The EULAR Scleroderma Trials and Research Group (EUSTAR): an international framework for accelerating scleroderma research.

    Science.gov (United States)

    Tyndall, Alan; Ladner, Ulf M; Matucci-Cerinic, Marco

    2008-11-01

    Systemic sclerosis has a complex pathogenesis and a multifaceted clinical spectrum without a specific treatment. Under the auspices of the European League Against Rheumatism, the European League Against Rheumatism Scleroderma Trials And Research group (EUSTAR) has been founded in Europe to foster the study of systemic sclerosis with the aim of achieving equality of assessment and care of systemic sclerosis patients throughout the world according to evidence-based principles. EUSTAR created the minimal essential data set, a simple two-page form with basic demographics and mostly yes/no answers to clinical and laboratory parameters, to track patients throughout Europe. Currently, over 7000 patients are registered from 150 centres in four continents, and several articles have been published with the data generated by the minimal essential data set. A commitment of EUSTAR is also to teaching and educating, and for this reason there are two teaching courses and a third is planned for early in 2009. These courses have built international networks among young investigators improving the quality of multicentre clinical trials. EUSTAR has organized several rounds of 'teach the teachers' to further standardize the skin scoring. EUSTAR activities have extended beyond European borders, and EUSTAR now includes experts from several nations. The growth of data and biomaterial might ensure many further fruitful multicentre studies, but the financial sustainability of EUSTAR remains an issue that may jeopardize the existence of this group as well as that of other organizations in the world.

  10. Research findings are catalyst to nationwide HIV prevention trial in ...

    International Development Research Centre (IDRC) Digital Library (Canada)

    2017-12-20

    Dec 20, 2017 ... ... who are less able to make the right choices to protect themselves — has ... A related project, also supported by IDRC, provided training to boost ... The trial interventions had the most impact among young women in Botswana. ... of the young women in communities who received the intervention package.

  11. Building Capacity for HIV/AIDS Prevention Trials Research and ...

    International Development Research Centre (IDRC) Digital Library (Canada)

    A relatively small number of African sites have the clinical and laboratory capacity to design, manage and carry out HIV/AIDS prevention trials. This project is based on the premise that many of the required skills are already present at additional locations, but need further development. The grant will facilitate interaction ...

  12. Beyond Randomized Controlled Trials in Attempted Suicide Research

    Science.gov (United States)

    Hatcher, Simon; Sharon, Cynthia; Coggan, Carol

    2009-01-01

    There is a lack of evidence about what is the best treatment for people who present to hospital after self harm. Most treatment trials have been small and involved unrepresentative groups of patients which result in inconclusive findings. Here we note some of the characteristics of attempted suicide which make it a difficult subject to study. We…

  13. Verification of analysis methods for predicting the behaviour of seismically isolated nuclear structures. Final report of a co-ordinated research project 1996-1999

    International Nuclear Information System (INIS)

    2002-06-01

    This report is a summary of the work performed under a co-ordinated research project (CRP) entitled Verification of Analysis Methods for Predicting the Behaviour of Seismically isolated Nuclear Structures. The project was organized by the IAEA on the recommendation of the IAEA's Technical Working Group on Fast Reactors (TWGFR) and carried out from 1996 to 1999. One of the primary requirements for nuclear power plants and facilities is to ensure safety and the absence of damage under strong external dynamic loading from, for example, earthquakes. The designs of liquid metal cooled fast reactors (LMFRs) include systems which operate at low pressure and include components which are thin-walled and flexible. These systems and components could be considerably affected by earthquakes in seismic zones. Therefore, the IAEA through its advanced reactor technology development programme supports the activities of Member States to apply seismic isolation technology to LMFRs. The application of this technology to LMFRs and other nuclear plants and related facilities would offer the advantage that standard designs may be safely used in areas with a seismic risk. The technology may also provide a means of seismically upgrading nuclear facilities. Design analyses applied to such critical structures need to be firmly established, and the CRP provided a valuable tool in assessing their reliability. Ten organizations from India, Italy, Japan, the Republic of Korea, the Russian Federation, the United Kingdom, the United States of America and the European Commission co-operated in this CRP. This report documents the CRP activities, provides the main results and recommendations and includes the work carried out by the research groups at the participating institutes within the CRP on verification of their analysis methods for predicting the behaviour of seismically isolated nuclear structures

  14. Non-commercial vs. commercial clinical trials: a retrospective study of the applications submitted to a research ethics committee.

    Science.gov (United States)

    Fuentes Camps, Inmaculada; Rodríguez, Alexis; Agustí, Antonia

    2018-02-15

    There are many difficulties in undertaking independent clinical research without support from the pharmaceutical industry. In this retrospective observational study, some design characteristics, the clinical trial public register and the publication rate of noncommercial clinical trials were compared to those of commercial clinical trials. A total of 809 applications of drug-evaluation clinical trials were submitted from May 2004 to May 2009 to the research ethics committee of a tertiary hospital, and 16.3% of trials were noncommercial. They were mainly phase IV, multicentre national, and unmasked controlled trials, compared to the commercial trials that were mainly phase II or III, multicentre international, and double-blind masked trials. The commercial trials were registered and published more often than noncommercial trials. More funding for noncommercial research is still needed. The results of the research, commercial or noncommercial, should be disseminated in order not to compromise either its scientific or its social value. © 2018 The British Pharmacological Society.

  15. Proceedings of the 22nd Annual DoD/DOE Seismic Research Symposium: Planning for Verification of and Compliance with the Comprehensive Nuclear-Test-Ban Treaty (CTBT)

    Energy Technology Data Exchange (ETDEWEB)

    Nichols, James W., LTC [Editor

    2000-09-15

    These proceedings contain papers prepared for the 22nd Annual DoD/DOE Seismic Research Symposium: Planning for Verification of and Compliance with the Comprehensive Nuclear-Test-Ban Treaty (CTBT), held 13-15 September 2000 in New Orleans, Louisiana. These papers represent the combined research related to ground-based nuclear explosion monitoring funded by the National Nuclear Security Administration (NNSA), Defense Threat Reduction Agency (DTRA), Air Force Technical Applications Center (AFTAC), Department of Defense (DoD), US Army Space and Missile Defense Command, Defense Special Weapons Agency (DSWA), and other invited sponsors. The scientific objectives of the research are to improve the United States capability to detect, locate, and identify nuclear explosions. The purpose of the meeting is to provide the sponsoring agencies, as well as potential users, an opportunity to review research accomplished during the preceding year and to discuss areas of investigation for the coming year. For the researchers, it provides a forum for the exchange of scientific information toward achieving program goals, and an opportunity to discuss results and future plans. Paper topics include: seismic regionalization and calibration; detection and location of sources; wave propagation from source to receiver; the nature of seismic sources, including mining practices; hydroacoustic, infrasound, and radionuclide methods; on-site inspection; and data processing.

  16. Research gaps identified during systematic reviews of clinical trials: glass-ionomer cements.

    Science.gov (United States)

    Mickenautsch, Steffen

    2012-06-29

    To report the results of an audit concerning research gaps in clinical trials that were accepted for appraisal in authored and published systematic reviews regarding the application of glass-ionomer cements (GIC) in dental practice Information concerning research gaps in trial precision was extracted, following a framework that included classification of the research gap reasons: 'imprecision of information (results)', 'biased information', 'inconsistency or unknown consistency' and 'not the right information', as well as research gap characterization using PICOS elements: population (P), intervention (I), comparison (C), outcomes (O) and setting (S). Internal trial validity assessment was based on the understanding that successful control for systematic error cannot be assured on the basis of inclusion of adequate methods alone, but also requires empirical evidence about whether such attempt was successful. A comprehensive and interconnected coverage of GIC-related clinical topics was established. The most common reasons found for gaps in trial precision were lack of sufficient trials and lack of sufficient large sample size. Only a few research gaps were ascribed to 'Lack of information' caused by focus on mainly surrogate trial outcomes. According to the chosen assessment criteria, a lack of adequate randomisation, allocation concealment and blinding/masking in trials covering all reviewed GIC topics was noted (selection- and detection/performance bias risk). Trial results appear to be less affected by loss-to-follow-up (attrition bias risk). This audit represents an adjunct of the systematic review articles it has covered. Its results do not change the systematic review's conclusions but highlight existing research gaps concerning the precision and internal validity of reviewed trials in detail. These gaps should be addressed in future GIC-related clinical research.

  17. Research gaps identified during systematic reviews of clinical trials: glass-ionomer cements

    Directory of Open Access Journals (Sweden)

    Mickenautsch Steffen

    2012-06-01

    Full Text Available Abstract Background To report the results of an audit concerning research gaps in clinical trials that were accepted for appraisal in authored and published systematic reviews regarding the application of glass-ionomer cements (GIC in dental practice Methods Information concerning research gaps in trial precision was extracted, following a framework that included classification of the research gap reasons: ‘imprecision of information (results’, ‘biased information’, ‘inconsistency or unknown consistency’ and ‘not the right information’, as well as research gap characterization using PICOS elements: population (P, intervention (I, comparison (C, outcomes (O and setting (S. Internal trial validity assessment was based on the understanding that successful control for systematic error cannot be assured on the basis of inclusion of adequate methods alone, but also requires empirical evidence about whether such attempt was successful. Results A comprehensive and interconnected coverage of GIC-related clinical topics was established. The most common reasons found for gaps in trial precision were lack of sufficient trials and lack of sufficient large sample size. Only a few research gaps were ascribed to ‘Lack of information’ caused by focus on mainly surrogate trial outcomes. According to the chosen assessment criteria, a lack of adequate randomisation, allocation concealment and blinding/masking in trials covering all reviewed GIC topics was noted (selection- and detection/performance bias risk. Trial results appear to be less affected by loss-to-follow-up (attrition bias risk. Conclusion This audit represents an adjunct of the systematic review articles it has covered. Its results do not change the systematic review’s conclusions but highlight existing research gaps concerning the precision and internal validity of reviewed trials in detail. These gaps should be addressed in future GIC-related clinical research.

  18. Participant recruitment and motivation for participation in optical technology for cervical cancer screening research trials.

    Science.gov (United States)

    Shuhatovich, Olga M; Sharman, Mathilde P; Mirabal, Yvette N; Earle, Nan R; Follen, Michele; Basen-Engquist, Karen

    2005-12-01

    In order to improve recruitment for cervical cancer screening trials, it is necessary to analyze the effectiveness of recruitment strategies used in current trials. A trial to test optical spectroscopy for the diagnosis of cervical neoplasia recruited 1000 women from the community; the trial evaluated the emerging technology against Pap smears and colposcopically directed biopsies for cervical dysplasia. We have examined women's reasons for participating as well as the effectiveness and efficiency for each recruitment strategy. Reasons for participation were identified and compared between trials. The recruitment method that resulted in the most contacts was newspaper reportorial coverage and advertising, followed by family and friends, then television news coverage. The most cost-effective method for finding eligible women who attend the research appointment is word of mouth from a family member or friend. Recommendations are given for maximizing the efficiency of recruitment for cervical cancer screening trials.

  19. Predictors of Missed Research Appointments in a Randomized Placebo-Controlled Trial

    Directory of Open Access Journals (Sweden)

    Stéphanie J.E. Becker

    2014-09-01

     Younger patients with no college education, who believe their health can be controlled, are more likely to miss a research appointment when enrolled in a randomized placebo injection-controlled trial

  20. Evaluation of cluster-randomized trials on maternal and child health research in developing countries

    DEFF Research Database (Denmark)

    Handlos, Line Neerup; Chakraborty, Hrishikesh; Sen, Pranab Kumar

    2009-01-01

    To summarize and evaluate all publications including cluster-randomized trials used for maternal and child health research in developing countries during the last 10 years. METHODS: All cluster-randomized trials published between 1998 and 2008 were reviewed, and those that met our criteria...... for inclusion were evaluated further. The criteria for inclusion were that the trial should have been conducted in maternal and child health care in a developing country and that the conclusions should have been made on an individual level. Methods of accounting for clustering in design and analysis were......, and the trials generally improved in quality. CONCLUSIONS: Shortcomings exist in the sample-size calculations and in the analysis of cluster-randomized trials conducted during maternal and child health research in developing countries. Even though there has been improvement over time, further progress in the way...

  1. Supporting Policy In health with Research: an Intervention Trial (SPIRIT)—protocol for a stepped wedge trial

    Science.gov (United States)

    2014-01-01

    Introduction Governments in different countries have committed to better use of evidence from research in policy. Although many programmes are directed at assisting agencies to better use research, there have been few tests of the effectiveness of such programmes. This paper describes the protocol for SPIRIT (Supporting Policy In health with Research: an Intervention Trial), a trial designed to test the effectiveness of a multifaceted programme to build organisational capacity for the use of research evidence in policy and programme development. The primary aim is to determine whether SPIRIT results in an increase in the extent to which research and research expertise is sought, appraised, generated and used in the development of specific policy products produced by health policy agencies. Methods and analysis A stepped wedge cluster randomised trial involving six health policy agencies located in Sydney, Australia. Policy agencies are the unit of randomisation and intervention. Agencies were randomly allocated to one of three start dates (steps) to receive the 1-year intervention programme, underpinned by an action framework. The SPIRIT intervention is tailored to suit the interests and needs of each agency and includes audit, feedback and goal setting; a leadership programme; staff training; the opportunity to test systems to assist in the use of research in policies; and exchange with researchers. Outcome measures will be collected at each agency every 6 months for 30 months (starting at the beginning of step 1). Ethics and dissemination Ethics approval was granted by the University of Western Sydney Human Research and Ethics Committee HREC Approval H8855. The findings of this study will be disseminated broadly through peer-reviewed publications and presentations at conferences and used to inform future strategies. PMID:24989620

  2. Standardized End Point Definitions for Coronary Intervention Trials: The Academic Research Consortium-2 Consensus Document.

    Science.gov (United States)

    Garcia-Garcia, Hector M; McFadden, Eugène P; Farb, Andrew; Mehran, Roxana; Stone, Gregg W; Spertus, John; Onuma, Yoshinobu; Morel, Marie-Angèle; van Es, Gerrit-Anne; Zuckerman, Bram; Fearon, William F; Taggart, David; Kappetein, Arie-Pieter; Krucoff, Mitchell W; Vranckx, Pascal; Windecker, Stephan; Cutlip, Donald; Serruys, Patrick W

    2018-06-14

    The Academic Research Consortium (ARC)-2 initiative revisited the clinical and angiographic end point definitions in coronary device trials, proposed in 2007, to make them more suitable for use in clinical trials that include increasingly complex lesion and patient populations and incorporate novel devices such as bioresorbable vascular scaffolds. In addition, recommendations for the incorporation of patient-related outcomes in clinical trials are proposed. Academic Research Consortium-2 is a collaborative effort between academic research organizations in the United States and Europe, device manufacturers, and European, US, and Asian regulatory bodies. Several in-person meetings were held to discuss the changes that have occurred in the device landscape and in clinical trials and regulatory pathways in the last decade. The consensus-based end point definitions in this document are endorsed by the stakeholders of this document and strongly advocated for clinical trial purposes. This Academic Research Consortium-2 document provides further standardization of end point definitions for coronary device trials, incorporating advances in technology and knowledge. Their use will aid interpretation of trial outcomes and comparison among studies, thus facilitating the evaluation of the safety and effectiveness of these devices.

  3. Clinical verification in homeopathy and allergic conditions.

    Science.gov (United States)

    Van Wassenhoven, Michel

    2013-01-01

    The literature on clinical research in allergic conditions treated with homeopathy includes a meta-analysis of randomised controlled trials (RCT) for hay fever with positive conclusions and two positive RCTs in asthma. Cohort surveys using validated Quality of Life questionnaires have shown improvement in asthma in children, general allergic conditions and skin diseases. Economic surveys have shown positive results in eczema, allergy, seasonal allergic rhinitis, asthma, food allergy and chronic allergic rhinitis. This paper reports clinical verification of homeopathic symptoms in all patients and especially in various allergic conditions in my own primary care practice. For preventive treatments in hay fever patients, Arsenicum album was the most effective homeopathic medicine followed by Nux vomica, Pulsatilla pratensis, Gelsemium, Sarsaparilla, Silicea and Natrum muriaticum. For asthma patients, Arsenicum iodatum appeared most effective, followed by Lachesis, Calcarea arsenicosa, Carbo vegetabilis and Silicea. For eczema and urticaria, Mezereum was most effective, followed by Lycopodium, Sepia, Arsenicum iodatum, Calcarea carbonica and Psorinum. The choice of homeopathic medicine depends on the presence of other associated symptoms and 'constitutional' features. Repertories should be updated by including results of such clinical verifications of homeopathic prescribing symptoms. Copyright © 2012 The Faculty of Homeopathy. Published by Elsevier Ltd. All rights reserved.

  4. Software verification for nuclear industry

    International Nuclear Information System (INIS)

    Wilburn, N.P.

    1985-08-01

    Why verification of software products throughout the software life cycle is necessary is considered. Concepts of verification, software verification planning, and some verification methodologies for products generated throughout the software life cycle are then discussed

  5. Supporting open access to clinical trial data for researchers: The Duke Clinical Research Institute-Bristol-Myers Squibb Supporting Open Access to Researchers Initiative.

    Science.gov (United States)

    Pencina, Michael J; Louzao, Darcy M; McCourt, Brian J; Adams, Monique R; Tayyabkhan, Rehbar H; Ronco, Peter; Peterson, Eric D

    2016-02-01

    There are growing calls for sponsors to increase transparency by providing access to clinical trial data. In response, Bristol-Myers Squibb and the Duke Clinical Research Institute have collaborated on a new initiative, Supporting Open Access to Researchers. The aim is to facilitate open sharing of Bristol-Myers Squibb trial data with interested researchers. Key features of the Supporting Open Access to Researchers data sharing model include an independent review committee that ensures expert consideration of each proposal, stringent data deidentification/anonymization and protection of patient privacy, requirement of prespecified statistical analysis plans, and independent review of manuscripts before submission for publication. We believe that these approaches will promote open science by allowing investigators to verify trial results as well as to pursue interesting secondary uses of trial data without compromising scientific integrity. Copyright © 2015 Elsevier Inc. All rights reserved.

  6. Clinical trial network for the promotion of clinical research for rare diseases in Japan: muscular dystrophy clinical trial network.

    Science.gov (United States)

    Shimizu, Reiko; Ogata, Katsuhisa; Tamaura, Akemi; Kimura, En; Ohata, Maki; Takeshita, Eri; Nakamura, Harumasa; Takeda, Shin'ichi; Komaki, Hirofumi

    2016-07-11

    Duchenne muscular dystrophy (DMD) is the most commonly inherited neuromuscular disease. Therapeutic agents for the treatment of rare disease, namely "orphan drugs", have recently drawn the attention of researchers and pharmaceutical companies. To ensure the successful conduction of clinical trials to evaluate novel treatments for patients with rare diseases, an appropriate infrastructure is needed. One of the effective solutions for the lack of infrastructure is to establish a network of rare diseases. To accomplish the conduction of clinical trials in Japan, the Muscular dystrophy clinical trial network (MDCTN) was established by the clinical research group for muscular dystrophy, including the National Center of Neurology and Psychiatry, as well as national and university hospitals, all which have a long-standing history of research cooperation. Thirty-one medical institutions (17 national hospital organizations, 10 university hospitals, 1 national center, 2 public hospitals, and 1 private hospital) belong to this network and collaborate to facilitate clinical trials. The Care and Treatment Site Registry (CTSR) calculates and reports the proportion of patients with neuromuscular diseases in the cooperating sites. In total, there are 5,589 patients with neuromuscular diseases in Japan and the proportion of patients with each disease is as follows: DMD, 29 %; myotonic dystrophy type 1, 23 %; limb girdle muscular dystrophy, 11 %; Becker muscular dystrophy, 10 %. We work jointly to share updated health care information and standardized evaluations of clinical outcomes as well. The collaboration with the patient registry (CTSR), allows the MDCTN to recruit DMD participants with specific mutations and conditions, in a remarkably short period of time. Counting with a network that operates at a national level is important to address the corresponding national issues. Thus, our network will be able to contribute with international research activity, which can lead to

  7. Verification and disarmament

    Energy Technology Data Exchange (ETDEWEB)

    Blix, H. [IAEA, Vienna (Austria)

    1998-07-01

    The main features are described of the IAEA safeguards verification system that non-nuclear weapon states parties of the NPT are obliged to accept. Verification activities/problems in Iraq and North Korea are discussed.

  8. Verification and disarmament

    International Nuclear Information System (INIS)

    Blix, H.

    1998-01-01

    The main features are described of the IAEA safeguards verification system that non-nuclear weapon states parties of the NPT are obliged to accept. Verification activities/problems in Iraq and North Korea are discussed

  9. Rethinking Research Ethics: The Case of Postmarketing Trials

    Science.gov (United States)

    London, Alex John; Carlisle, Benjamin

    2015-01-01

    Phase IV studies are often criticized for poor scientific standards. Yet they provide an important resource for addressing evidence shortfalls in drug safety, comparative effectiveness, and real-world utility. Current research ethics policies, and contemplated revisions to them, do not provide an adequate framework for preventing social harms that result from poor post-marketing research practice. Rather than focus exclusively on the welfare and interests of human volunteers, research policies and ethics should also safeguard the integrity of the research enterprise as a system for producing reliable medical evidence. We close by briefly describing how an integrity framework might be implemented for phase IV studies. PMID:22556237

  10. The UK clinical research network - has it been a success for dermatology clinical trials?

    Directory of Open Access Journals (Sweden)

    Charlesworth Lisa

    2011-06-01

    Full Text Available Abstract Background Following the successful introduction of five topic-specific research networks in the UK, the Comprehensive Local Research Network (CLRN was established in 2008 in order to provide a blanket level of support across the whole country regardless of the clinical discipline. The role of the CLRN was to facilitate recruitment into clinical trials, and to encourage greater engagement in research throughout the National Health Service (NHS. Methods This report evaluates the impact of clinical research networks in supporting clinical trials in the UK, with particular reference to our experiences from two non-commercial dermatology trials. It covers our experience of engaging with the CLRN (and other research networks using two non-commercial dermatology trials as case studies. We present the circumstances that led to our approach to the research networks for support, and the impact that this support had on the delivery of these trials. Results In both cases, recruitment was boosted considerably following the provision of additional support, although other factors such as the availability of experienced personnel, and the role of advertising and media coverage in promoting the trials were also important in translating this additional resource into increased recruitment. Conclusions Recruitment into clinical trials is a complex task that can be influenced by many factors. A world-class clinical research infrastructure is now in place in England (with similar support available in Scotland and Wales, and it is the responsibility of the research community to ensure that this unique resource is used effectively and responsibly.

  11. Exercise and manual physiotherapy arthritis research trial (EMPART): a multicentre randomised controlled trial.

    LENUS (Irish Health Repository)

    French, Helen P

    2009-01-01

    Osteoarthritis (OA) of the hip is a major cause of functional disability and reduced quality of life. Management options aim to reduce pain and improve or maintain physical functioning. Current evidence indicates that therapeutic exercise has a beneficial but short-term effect on pain and disability, with poor long-term benefit. The optimal content, duration and type of exercise are yet to be ascertained. There has been little scientific investigation into the effectiveness of manual therapy in hip OA. Only one randomized controlled trial (RCT) found greater improvements in patient-perceived improvement and physical function with manual therapy, compared to exercise therapy.

  12. A research on verification of the CONTAIN CODE model and the uncertainty reduction method for containment integrity

    Energy Technology Data Exchange (ETDEWEB)

    Park, Jae Hong [Korea Institute of Nuclear Safety, Taejon (Korea, Republic of); Kim, Moo Hwan; Kang, Seok Hun; Seo, Kyoung Woo [Pohang University of Science and Technology, Pohang (Korea, Republic of)

    1999-03-15

    The final goal of this research is to verify methodology for evaluating more accurately the integrity of containment and develop the methodology to reduce the uncertainty using the data of the operating PWR, KSNPP, KNGR during a severe accident. Therefore, the research selected an indispensable factor about DCH, and analysed sensitivity test at this year.

  13. A research on verification of the models in the CONTAIN Code and the uncertainty reduction method for containment integrity evaluation

    Energy Technology Data Exchange (ETDEWEB)

    Kim, Moo Hwan; Seo, Kyoung Woo [Pohang University of Science and Technology, Pohang (Korea, Republic of)

    2000-03-15

    The final goal of this research is to evaluate synthetic results of DCH issue and expose accurate methodology to assess containment integrity about operating PWR in Korea. This research is aimed to expose methodology for synthetic resolution of the DCH issue for KSNPP, and make the guide of DCH issue for containment integrity which will be used to design to nuclear power plants.

  14. Static Verification for Code Contracts

    Science.gov (United States)

    Fähndrich, Manuel

    The Code Contracts project [3] at Microsoft Research enables programmers on the .NET platform to author specifications in existing languages such as C# and VisualBasic. To take advantage of these specifications, we provide tools for documentation generation, runtime contract checking, and static contract verification.

  15. Priorities for methodological research on patient and public involvement in clinical trials: A modified Delphi process.

    Science.gov (United States)

    Kearney, Anna; Williamson, Paula; Young, Bridget; Bagley, Heather; Gamble, Carrol; Denegri, Simon; Muir, Delia; Simon, Natalie A; Thomas, Stephen; Elliot, Jim T; Bulbeck, Helen; Crocker, Joanna C; Planner, Claire; Vale, Claire; Clarke, Mike; Sprosen, Tim; Woolfall, Kerry

    2017-12-01

    Despite increasing international interest, there is a lack of evidence about the most efficient, effective and acceptable ways to implement patient and public involvement (PPI) in clinical trials. To identify the priorities of UK PPI stakeholders for methodological research to help resolve uncertainties about PPI in clinical trials. A modified Delphi process including a two round online survey and a stakeholder consensus meeting. In total, 237 people registered of whom 219 (92%) completed the first round. One hundred and eighty-seven of 219 (85%) completed the second; 25 stakeholders attended the consensus meeting. Round 1 of the survey comprised 36 topics; 42 topics were considered in round 2 and at the consensus meeting. Approximately 96% of meeting participants rated the top three topics as equally important. These were as follows: developing strong and productive working relationships between researchers and PPI contributors; exploring PPI practices in selecting trial outcomes of importance to patients; and a systematic review of PPI activity to improve the accessibility and usefulness of trial information (eg participant information sheets) for participants. The prioritized methodological research topics indicate important areas of uncertainty about PPI in trials. Addressing these uncertainties will be critical to enhancing PPI. Our findings should be used in the planning and funding of PPI in clinical trials to help focus research efforts and minimize waste. © 2017 The Authors Health Expectations Published by John Wiley & Sons Ltd.

  16. Reducing placebo exposure in trials: Considerations from the Research Roundtable in Epilepsy.

    Science.gov (United States)

    Fureman, Brandy E; Friedman, Daniel; Baulac, Michel; Glauser, Tracy; Moreno, Jonathan; Dixon-Salazar, Tracy; Bagiella, Emilia; Connor, Jason; Ferry, Jim; Farrell, Kathleen; Fountain, Nathan B; French, Jacqueline A

    2017-10-03

    The randomized controlled trial is the unequivocal gold standard for demonstrating clinical efficacy and safety of investigational therapies. Recently there have been concerns raised about prolonged exposure to placebo and ineffective therapy during the course of an add-on regulatory trial for new antiepileptic drug approval (typically ∼6 months in duration), due to the potential risks of continued uncontrolled epilepsy for that period. The first meeting of the Research Roundtable in Epilepsy on May 19-20, 2016, focused on "Reducing placebo exposure in epilepsy clinical trials," with a goal of considering new designs for epilepsy regulatory trials that may be added to the overall development plan to make it, as a whole, safer for participants while still providing rigorous evidence of effect. This topic was motivated in part by data from a meta-analysis showing a 3- to 5-fold increased rate of sudden unexpected death in epilepsy in participants randomized to placebo or ineffective doses of new antiepileptic drugs. The meeting agenda included rationale and discussion of different trial designs, including active-control add-on trials, placebo add-on to background therapy with adjustment, time to event designs, adaptive designs, platform trials with pooled placebo control, a pharmacokinetic/pharmacodynamic approach to reducing placebo exposure, and shorter trials when drug tolerance has been ruled out. The merits and limitations of each design were discussed and are reviewed here. © 2017 American Academy of Neurology.

  17. A Review of Barriers to Minorities' Participation in Cancer Clinical Trials: Implications for Future Cancer Research.

    Science.gov (United States)

    Salman, Ali; Nguyen, Claire; Lee, Yi-Hui; Cooksey-James, Tawna

    2016-04-01

    To enhance nurses' awareness and competencies in practice and research by reporting the common barriers to participation of minorities in cancer clinical trials and discussing facilitators and useful strategies for recruitment. Several databases were searched for articles published in peer reviewed journals. Some of the barriers to minorities' participation in clinical trials were identified within the cultural social-context of cancer patients. The involvement of community networking was suggested as the most effective strategy for the recruitment of minorities in cancer clinical trials. Using culturally sensitive approaches to enhance ethnic minorities' participation is important for advancing cancer care and eliminating health disparities. Awareness of barriers and potential facilitators to the enrollment of ethnic minority cancer patients may contribute to enhancing nurses' competencies of recruiting ethnic minorities in nursing research, playing efficient roles in cancer clinical trials team, and providing culturally competent quality care.

  18. Turning Failure into Success: Trials of the Heart Failure Clinical Research Network.

    Science.gov (United States)

    Joyce, Emer; Givertz, Michael M

    2016-12-01

    The Heart Failure Clinical Research Network (HFN) was established in 2008 on behalf of the NIH National Heart, Lung and Blood Institute, with the primary goal of improving outcomes in heart failure (HF) by designing and conducting high-quality concurrent clinical trials testing interventions across the spectrum of HF. Completed HFN trials have answered several important and relevant clinical questions concerning the safety and efficacy of different decongestive and adjunctive vasodilator therapies in hospitalized acute HF, phosphodiesterase-5 inhibition and nitrate therapies in HF with preserved ejection fraction, and the role of xanthine oxidase inhibition in hyperuricemic HF. These successes, independent of the "positive" or "negative" result of each individual trial, have helped to shape the current clinical care of HF patients and serve as a platform to inform future research directions and trial designs.

  19. Global health trials methodological research agenda:results from a priority setting exercise

    OpenAIRE

    Blazeby, Jane; Nasser, Mona; Soares-Weiser, Karla; Sydes, Matthew R.; Zhang, Junhua; Williamson, Paula R

    2018-01-01

    BackgroundMethodological research into the design, conduct, analysis and reporting of trials is essential to optimise the process. UK specialists in the field have established a set of top priorities in aid of this research. These priorities however may not be reflected in the needs of similar research in low to middle income countries (LMICs) with different healthcare provision, resources and research infrastructure. The aim of the study was to identify the top priorities for methodological ...

  20. Shedding light on research participation effects in behaviour change trials: a qualitative study examining research participant experiences

    Directory of Open Access Journals (Sweden)

    Virginia MacNeill

    2016-01-01

    Full Text Available Abstract Background The sequence of events in a behaviour change trial involves interactions between research participants and the trial process. Taking part in such a study has the potential to influence the behaviour of the participant, and if it does, this can engender bias in trial outcomes. Since participants’ experience has received scant attention, the aim of this study is thus to generate hypotheses about which aspects of the conduct of behaviour change trials might matter most to participants, and thus have potential to alter subsequent behaviours and bias trial outcomes Methods Twenty participants were opportunistically screened for a health compromising behaviour (unhealthy diet, lack of exercise, smoking or alcohol consumption and recruited if eligible. Semi structured face to face interviews were conducted, after going through the usual processes involved in trial recruitment, baseline assessment and randomisation. Participants were given information on the contents of an intervention or control condition in a behaviour change trial, which was not actually implemented. Three months later they returned to reflect on these experiences and whether they had any effect on their behaviour during the intervening period. Data from the latter interview were analysed thematically using a modified grounded theory approach. Results The early processes of trial participation raised awareness of unhealthy behaviours, although most reported having had only fleeting intentions to change their behaviour as a result of taking part in this study, in the absence of interventions. However, careful examination of the accounts revealed evidence of subtle research participation effects, which varied according to the health behaviour, and its perceived social acceptability. Participants’ relationships with the research study were viewed as somewhat important in stimulating thinking about whether and how to make lifestyle changes. Conclusion These

  1. Shedding light on research participation effects in behaviour change trials: a qualitative study examining research participant experiences.

    Science.gov (United States)

    MacNeill, Virginia; Foley, Marian; Quirk, Alan; McCambridge, Jim

    2016-01-29

    The sequence of events in a behaviour change trial involves interactions between research participants and the trial process. Taking part in such a study has the potential to influence the behaviour of the participant, and if it does, this can engender bias in trial outcomes. Since participants' experience has received scant attention, the aim of this study is thus to generate hypotheses about which aspects of the conduct of behaviour change trials might matter most to participants, and thus have potential to alter subsequent behaviours and bias trial outcomes Twenty participants were opportunistically screened for a health compromising behaviour (unhealthy diet, lack of exercise, smoking or alcohol consumption) and recruited if eligible. Semi structured face to face interviews were conducted, after going through the usual processes involved in trial recruitment, baseline assessment and randomisation. Participants were given information on the contents of an intervention or control condition in a behaviour change trial, which was not actually implemented. Three months later they returned to reflect on these experiences and whether they had any effect on their behaviour during the intervening period. Data from the latter interview were analysed thematically using a modified grounded theory approach. The early processes of trial participation raised awareness of unhealthy behaviours, although most reported having had only fleeting intentions to change their behaviour as a result of taking part in this study, in the absence of interventions. However, careful examination of the accounts revealed evidence of subtle research participation effects, which varied according to the health behaviour, and its perceived social acceptability. Participants' relationships with the research study were viewed as somewhat important in stimulating thinking about whether and how to make lifestyle changes. These participants described no dramatic impacts attributable to taking part in

  2. Researchers', Regulators', and Sponsors' Views on Pediatric Clinical Trials: A Multinational Study.

    Science.gov (United States)

    Joseph, Pathma D; Craig, Jonathan C; Tong, Allison; Caldwell, Patrina H Y

    2016-10-01

    The last decade has seen dramatic changes in the regulatory landscape to support more trials involving children, but child-specific challenges and inequitable conduct across income regions persist. The goal of this study was to describe the attitudes and opinions of stakeholders toward trials in children, to inform additional strategies to promote more high-quality, relevant pediatric trials across the globe. Key informant semi-structured interviews were conducted with stakeholders (researchers, regulators, and sponsors) who were purposively sampled from low- to middle-income countries and high-income countries. The transcripts were thematically analyzed. Thirty-five stakeholders from 10 countries were interviewed. Five major themes were identified: addressing pervasive inequities (paucity of safety and efficacy data, knowledge disparities, volatile environment, double standards, contextual relevance, market-driven forces, industry sponsorship bias and prohibitive costs); contending with infrastructural barriers (resource constraints, dearth of pediatric trial expertise, and logistical complexities); navigating complex ethical and regulatory frameworks ("draconian" oversight, ambiguous requirements, exploitation, excessive paternalism and precariousness of coercion versus volunteerism); respecting uniqueness of children (pediatric research paradigms, child-appropriate approaches, and family-centered empowerment); and driving evidence-based child health (advocacy, opportunities, treatment access, best practices, and research prioritization). Stakeholders acknowledge that changes in the regulatory environment have encouraged more trials in children, but they contend that inequities and political, regulatory, and resource barriers continue to exist. Embedding trials as part of routine clinical care, addressing the unique needs of children, and streamlining regulatory approvals were suggested. Stakeholders recommended increasing international collaboration

  3. Effectiveness in practice-based research: Looking for alternatives to the randomized controlled trial (RCT)

    NARCIS (Netherlands)

    Tavecchio, L.

    2015-01-01

    Over the last decade, the status of the randomized controlled trial (RCT), hallmark of evidence-based medicine (research), has been growing strongly in general practice, social work and public health. But this type of research is only practicable under strictly controlled and well-defined settings

  4. Clinical Trial Design for HIV Prevention Research: Determining Standards of Prevention.

    Science.gov (United States)

    Dawson, Liza; Zwerski, Sheryl

    2015-06-01

    This article seeks to advance ethical dialogue on choosing standards of prevention in clinical trials testing improved biomedical prevention methods for HIV. The stakes in this area of research are high, given the continued high rates of infection in many countries and the budget limitations that have constrained efforts to expand treatment for all who are currently HIV-infected. New prevention methods are still needed; at the same time, some existing prevention and treatment interventions have been proven effective but are not yet widely available in the countries where they most urgently needed. The ethical tensions in this field of clinical research are well known and have been the subject of extensive debate. There is no single clinical trial design that can optimize all the ethically important goals and commitments involved in research. Several recent articles have described the current ethical difficulties in designing HIV prevention trials, especially in resource limited settings; however, there is no consensus on how to handle clinical trial design decisions, and existing international ethical guidelines offer conflicting advice. This article acknowledges these deep ethical dilemmas and moves beyond a simple descriptive approach to advance an organized method for considering what clinical trial designs will be ethically acceptable for HIV prevention trials, balancing the relevant criteria and providing justification for specific design decisions. Published 2014. This article is a U.S. Government work and is in the public domain in the USA.

  5. Reconciling research and community priorities in participatory trials: application to Padres Informados/Jovenes Preparados.

    Science.gov (United States)

    Allen, Michele L; Garcia-Huidobro, Diego; Bastian, Tiana; Hurtado, G Ali; Linares, Roxana; Svetaz, María Veronica

    2017-06-01

    Participatory research (PR) trials aim to achieve the dual, and at times competing, demands of producing an intervention and research process that address community perspectives and priorities, while establishing intervention effectiveness. To identify research and community priorities that must be reconciled in the areas of collaborative processes, study design and aim and study implementation quality in order to successfully conduct a participatory trial. We describe how this reconciliation was approached in the smoking prevention participatory trial Padres Informados/Jovenes Preparados (Informed Parents/Prepared Youth) and evaluate the success of our reconciled priorities. Data sources to evaluate success of the reconciliations included a survey of all partners regarding collaborative group processes, intervention participant recruitment and attendance and surveys of enrolled study participants assessing intervention outcomes. While we successfully achieved our reconciled collaborative processes and implementation quality goals, we did not achieve our reconciled goals in study aim and design. Due in part to the randomized wait-list control group design chosen in the reconciliation process, we were not able to demonstrate overall efficacy of the intervention or offer timely services to families in need of support. Achieving the goals of participatory trials is challenging but may yield community and research benefits. Innovative research designs are needed to better support the complex goals of participatory trials. © The Author 2017. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  6. Innovative designs for radiation oncology research in clinical trials

    International Nuclear Information System (INIS)

    Rubin, P.; Keys, H.; Salazar, O.

    1987-01-01

    The goals of the research mission are clear: (1) to explore in a logical, systematic, organized, and coordinated fashion those potential therapeutic advances that show promise; (2) to identify, in the laboratory, those models that predict successful combinations of treatment modes; (3) to search for ultimate treatment of programs that improve the therapeutic ratio. The modalities, innovations in treatment, and logic exist; it now rests with meticulous science to show carefully the directions that clinical research should follow in pursuit of the ultimate objective of improving cancer cure rates with less toxicity

  7. Establishing community advisory boards for clinical trial research in ...

    African Journals Online (AJOL)

    composition of CABs, leadership qualities, among others. This course places emphasis in areas that ICHGCP ... interests of the community function as a source of leadership in the partnerships between researchers and the .... This implied that the idea of volunteering or volunteer work during CAB training was not properly ...

  8. Research design considerations for chronic pain prevention clinical trials

    DEFF Research Database (Denmark)

    Gewandter, Jennifer S; Dworkin, Robert H; Turk, Dennis C

    2015-01-01

    Although certain risk factors can identify individuals who are most likely to develop chronic pain, few interventions to prevent chronic pain have been identified. To facilitate the identification of preventive interventions, an IMMPACT meeting was convened to discuss research design considerations...

  9. Effect of Contract Research Organization Bureaucracy in Clinical Trial Management: A Model From Lung Cancer.

    Science.gov (United States)

    Gobbini, Elisa; Pilotto, Sara; Pasello, Giulia; Polo, Valentina; Di Maio, Massimo; Arizio, Francesca; Galetta, Domenico; Petrillo, Patrizia; Chiari, Rita; Matocci, Roberta; Di Costanzo, Alessandro; Di Stefano, Teresa Severina; Aglietta, Massimo; Cagnazzo, Celeste; Sperduti, Isabella; Bria, Emilio; Novello, Silvia

    2018-03-01

    Contract research organization (CRO) support is largely included in clinical trial management, although its effect in terms of time savings and benefit has not yet been quantified. We performed a retrospective multicenter analysis of lung cancer trials to explore differences in term of trial activation timelines and accrual for studies with and without CRO involvement. Results regarding study timelines from feasibility data to first patient enrollment were collected from 7 Italian thoracic oncology departments. The final accruals (screened/enrolled patients) are reported. We considered CRO/sponsor-administered and CRO-free trials according to who was responsible for the management of the crucial setup phases. Of 113 trials, 62 (54.9%) were CRO-administered, 34 (30.1%) were sponsor-administered, and 17 (15.0%) were CRO-free. The median time from feasibility invitation to documentation obtainment was 151 days in the CRO-administered trials versus 128 in the sponsor-administered and 120 in the CRO-free trials. The time from document submission to contract signature was 142 days in the CRO-administered versus 128 in the sponsor-administered and 132 in the CRO-free trials. The time from global accrual opening to first patient enrollment was 247 days for the CRO-administered versus 194 in the sponsor-administered and 151 in the CRO-free trials. No significant differences were observed in terms of the median overall timeline: 21 months in the CRO-administered, 15 in the sponsor-administered, and 18 months in the CRO-free studies (P = .29). Although no statistically significant differences were identified, the results of our analysis support the idea that bureaucratic procedures might require more time in CRO-administered trials than in sponsor-administered and CRO-free studies. This bureaucratic delay could negatively affect Italian patients' screening and enrollment compared with other countries. Copyright © 2017 Elsevier Inc. All rights reserved.

  10. [Informed consent process in clinical trials: Insights of researchers, patients and general practitioners].

    Science.gov (United States)

    Giménez, Nuria; Pedrazas, David; Redondo, Susana; Quintana, Salvador

    2016-10-01

    Adequate information for patients and respect for their autonomy are mandatory in research. This article examined insights of researchers, patients and general practitioners (GPs) on the informed consent process in clinical trials, and the role of the GP. A cross-sectional study using three questionnaires, informed consent reviews, medical records, and hospital discharge reports. GPs, researchers and patients involved in clinical trials. Included, 504 GPs, 108 researchers, and 71 patients. Consulting the GP was recommended in 50% of the informed consents. Participation in clinical trials was shown in 33% of the medical records and 3% of the hospital discharge reports. GPs scored 3.54 points (on a 1-10 scale) on the assessment of the information received by the principal investigator. The readability of the informed consent sheet was rated 8.03 points by researchers, and the understanding was rated 7.68 points by patients. Patient satisfaction was positively associated with more time for reflection. GPs were not satisfied with the information received on the participation of patients under their in clinical trials. Researchers were satisfied with the information they offered to patients, and were aware of the need to improve the information GPs received. Patients collaborated greatly towards biomedical research, expressed satisfaction with the overall process, and minimised the difficulties associated with participation. Copyright © 2015 Elsevier España, S.L.U. All rights reserved.

  11. Exercise and manual physiotherapy arthritis research trial (EMPART: a multicentre randomised controlled trial

    Directory of Open Access Journals (Sweden)

    O'Connell Paul

    2009-01-01

    Full Text Available Abstract Background Osteoarthritis (OA of the hip is a major cause of functional disability and reduced quality of life. Management options aim to reduce pain and improve or maintain physical functioning. Current evidence indicates that therapeutic exercise has a beneficial but short-term effect on pain and disability, with poor long-term benefit. The optimal content, duration and type of exercise are yet to be ascertained. There has been little scientific investigation into the effectiveness of manual therapy in hip OA. Only one randomized controlled trial (RCT found greater improvements in patient-perceived improvement and physical function with manual therapy, compared to exercise therapy. Methods and design An assessor-blind multicentre RCT will be undertaken to compare the effect of a combination of manual therapy and exercise therapy, exercise therapy only, and a waiting-list control on physical function in hip OA. One hundred and fifty people with a diagnosis of hip OA will be recruited and randomly allocated to one of 3 groups: exercise therapy, exercise therapy with manual therapy and a waiting-list control. Subjects in the intervention groups will attend physiotherapy for 6–8 sessions over 8 weeks. Those in the control group will remain on the waiting list until after this time and will then be re-randomised to one of the two intervention groups. Outcome measures will include physical function (WOMAC, pain severity (numerical rating scale, patient perceived change (7-point Likert scale, quality of life (SF-36, mood (hospital anxiety and depression scale, patient satisfaction, physical activity (IPAQ and physical measures of range of motion, 50-foot walk and repeated sit-to stand tests. Discussion This RCT will compare the effectiveness of the addition of manual therapy to exercise therapy to exercise therapy only and a waiting-list control in hip OA. A high quality methodology will be used in keeping with CONSORT guidelines. The

  12. Feeding trials in organic food quality and health research

    DEFF Research Database (Denmark)

    Velimirov, Alberta; Huber, Machteld; Lauridsen, Charlotte

    2010-01-01

    Feeding experiments comparing organically and conventionally produced food are performed to assess the overall impact on the animals' health as a model for the effects experienced by the human consumers. These experiments are based on systems research and characterized by their focus on production...... research is not just about simple cause-effect chains, but rather about the pluralism of interactions in biological networks; therefore, the interpretation of the outcome of whole food experiments is difficult. Furthermore, the test diets of organic and conventional origin can be constituted in different...... methods, whole food testing and procedures in accordance with the terms of organic farming. A short review of such experiments shows that the majority of these tests revealed effects of the organically produced feed on health parameters such as reproductive performance and immune responses. Systems...

  13. Improving publication rates in a collaborative clinical trials research network

    OpenAIRE

    Archer, Stephanie Wilson; Carlo, Waldemar A.; Truog, William E.; Stevenson, David K.; Van Meurs, Krisa P.; Sánchez, Pablo J.; Das, Abhik; Devaskar, Uday; Nelin, Leif D.; Petrie Huitema, Carolyn M.; Crawford, Margaret M.; Higgins, Rosemary D.

    2016-01-01

    Unpublished results can bias biomedical literature, favoring positive over negative findings, primary over secondary analyses, and can lead to duplicate studies that unnecessarily endanger subjects and waste resources. The Neonatal Research Network’s (NRN) publication policies for approving, reviewing, and tracking abstracts and papers work to combat these problems. In 2003, the NRN restricted investigators with unfinished manuscripts from proposing new ones and in 2010, urged authors to comp...

  14. Compliance revisited: pharmaceutical drug trials in the era of the contract research organization.

    Science.gov (United States)

    Jonvallen, Petra

    2009-12-01

    Over the past decade, the management of clinical trials of pharmaceuticals has become a veritable industry, as evidenced by the emergence and proliferation of contract research organizations (CROs) that co-ordinate and monitor trials. This article focuses on work performed by one CRO involved in the introduction of new software, modelled on industrial production processes, into clinical trial practices. It investigates how this new management technique relates to the work performed in the clinic to ensure that trial participants comply with the protocol. Using an analytical distinction between 'classical' management work and invisible work, the article contextualizes the meaning of compliance in the clinic and suggests that the work involved in producing compliance should be taken into consideration by those concerned with validity of trials, as clinical trials are put under private industrial management. The article builds on participant observation at a Swedish university hospital and interviews the nurses, dieticians, doctors and a software engineer, all part of a team involved in pharmaceutical drug trials on a potential obesity drug.

  15. How many research nurses for how many clinical trials in an oncology setting? Definition of the Nursing Time Required by Clinical Trial-Assessment Tool (NTRCT-AT).

    Science.gov (United States)

    Milani, Alessandra; Mazzocco, Ketti; Stucchi, Sara; Magon, Giorgio; Pravettoni, Gabriella; Passoni, Claudia; Ciccarelli, Chiara; Tonali, Alessandra; Profeta, Teresa; Saiani, Luisa

    2017-02-01

    Few resources are available to quantify clinical trial-associated workload, needed to guide staffing and budgetary planning. The aim of the study is to describe a tool to measure clinical trials nurses' workload expressed in time spent to complete core activities. Clinical trials nurses drew up a list of nursing core activities, integrating results from literature searches with personal experience. The final 30 core activities were timed for each research nurse by an outside observer during daily practice in May and June 2014. Average times spent by nurses for each activity were calculated. The "Nursing Time Required by Clinical Trial-Assessment Tool" was created as an electronic sheet that combines the average times per specified activities and mathematic functions to return the total estimated time required by a research nurse for each specific trial. The tool was tested retrospectively on 141 clinical trials. The increasing complexity of clinical research requires structured approaches to determine workforce requirements. This study provides a tool to describe the activities of a clinical trials nurse and to estimate the associated time required to deliver individual trials. The application of the proposed tool in clinical research practice could provide a consistent structure for clinical trials nursing workload estimation internationally. © 2016 John Wiley & Sons Australia, Ltd.

  16. Modification and verification of the program COBRA-RERTR for the application in the thermohydraulic analysis of research reactors

    International Nuclear Information System (INIS)

    Hainoun, A.; Ghazi, N.

    2005-01-01

    In the frame work of testing, evaluation and application of computer codes in the design and safety analysis of research reactors, the thermal hydraulic code COBRA-RERTR (Reduced Enriched Research and Test Reactor) has been tested and partially validated. COBRA-RERTR has been selected due to the available options, which are suitable for the analysis of research reactors which are operated at low temperatures, and which may use plate-type fuel elements and heavy water as the coolant. In addition to that, the code enables the consideration of cross-flow that is important in case of parallel and open coolant channel. The test of the code shows an overestimation of the wall temperature with an addition to some fluctuation from node to node. This results from the solution scheme that uses an explicit, non-iterative solution for heat conduction and heat transfer to the coolant. The code evaluation regarding the basic thermal hydraulic phenomena indicates the necessity to modify and extent the physical models deals with the estimation of slip ratio and simulation of void content in the sub-cooled boiling. The code has been validated by recalculation of special experiments on axial void distribution and thermal hydraulic instability in the subcooled boiling regime. The validation indicates significant improvement of the code in prediction the axial void distribution in subcooled boiling. The discrepancy between calculation and experiments was about 20% after the modification comparing to 100% in the original models. On the other hand the validation shows the capability of the modified code to stimulate thermal hydraulic flow instability characterized by the critical inlet flow velocity at which the flow just become unstable. This point is identical to the minimum in the integral pressure drop curve. The code results show, from the view point of reactor safety, conservative estimation since the predicted values of critical inlet velocity are higher than the experimental

  17. Modification and verification of the program COBRA-RERTR for the application in the thermohydraulic analysis of research reactors

    International Nuclear Information System (INIS)

    Hainoun, A.; Ghazi, N.

    2004-02-01

    In the frame work of testing, evaluation and application of computer codes in the design and safety analysis of research reactors, the thermal hydraulic code COBRA-RERTR (Reduced Enriched Research and Test Reactor) has been tested and partially validated. COBRA-RERTR has been selected due to the available options, which are suitable for the analysis of research reactors which are operated at low temperatures, and which may use plate-type fuel elements and heavy water as the coolant. In addition to that, the code enables the consideration of cross-flow that is important in case of parallel and open coolant channel. The test of the code shows an overestimation of the wall temperature with an addition to some fluctuation from node to node. This results from the solution scheme that uses an explicit, non-iterative solution for heat conduction and heat transfer to the coolant. The code evaluation regarding the basic thermal hydraulic phenomena indicates the necessity to modify and extent the physical models deals with the estimation of slip ratio and simulation of void content in the sub-cooled boiling. The code has been validated by recalculation of special experiments on axial void distribution and thermal hydraulic instability in the subcooled boiling regime. The validation indicates significant improvement of the code in prediction the axial void distribution in subcooled boiling. The discrepancy between calculation and experiments was about 20% after the modification comparing to 100% in the original models. On the other hand the validation shows the capability of the modified code to stimulate thermal hydraulic flow instability characterized by the critical inlet flow velocity at which the flow just become unstable. This point is identical to the minimum in the integral pressure drop curve. The code results show, from the view point of reactor safety, conservative estimation since the predicted values of critical inlet velocity are higher than the experimental

  18. Quality verification for plate-type uranium-aluminum fuel elements for use in research reactors (Revision 1) - July 1976

    International Nuclear Information System (INIS)

    Anon.

    1977-01-01

    Paragraph (a) (7) of 50.34, Contents of Applications: Technical Information, of 10 CFR Part 50, Licensing of Production and Utilization Facilities, requires that each applicant for a construction permit to build a production or utilization facility include in its Preliminary Safety Analysis Report (PSAR) a description of the quality assurance program to be applied to the design, fabrication, construction, and testing of the structures, systems, and components of the facility. The Regulatory Guide presented describes a method acceptable to the NRC staff for establishing and executing a quality assurance program for verifying the quality of plate-type uranium-aluminum fuel elements used in research reactors

  19. The UK clinical research network - has it been a success for dermatology clinical trials?

    OpenAIRE

    Charlesworth Lisa; Perdue Jo; Foster Katharine; Koller Karin; Thomas Kim S; Chalmers Joanne R

    2011-01-01

    Abstract Background Following the successful introduction of five topic-specific research networks in the UK, the Comprehensive Local Research Network (CLRN) was established in 2008 in order to provide a blanket level of support across the whole country regardless of the clinical discipline. The role of the CLRN was to facilitate recruitment into clinical trials, and to encourage greater engagement in research throughout the National Health Service (NHS). Methods This report evaluates the imp...

  20. EPRI's on-site soil-structure interaction research and its application to design/analysis verification

    Energy Technology Data Exchange (ETDEWEB)

    Stepp, J C; Tang, H T [Seismic Center, Electric Power Research Institute, Palo Alto, CA (United States)

    1988-07-01

    Soil structure, interaction (SSI) research at the Electric Power Research Institute (EPRI) is focused on validating modeling and computational procedures. A data base has been obtained with instrumented scale models of stiff structures founded both on unsaturated alluvial soils and on rock. Explosives were used to induce strong ground-motion for two experiments, one on rock and the other on alluvium. A third experiment, a one-fourth scale containment structure on saturated alluvium, relies on earthquakes as the energy source. Analysis of the explosion-induced SSI data shows a marked shift in the fundamental frequency of the soil-structure system to a lower frequency. The magnitude of the shift is a function of foundation conditions and level of excitation. Analytical simulation was found to require more sophisticated soil constitutive models and computer codes than are used in current practice. The current phase of the program concentrates on evaluating SSI models used in current design practice by comparing predicted with recorded data at points in the soil-structure system. (author)

  1. EPRI's on-site soil-structure interaction research and its application to design/analysis verification

    International Nuclear Information System (INIS)

    Stepp, J.C.; Tang, H.T.

    1988-01-01

    Soil structure, interaction (SSI) research at the Electric Power Research Institute (EPRI) is focused on validating modeling and computational procedures. A data base has been obtained with instrumented scale models of stiff structures founded both on unsaturated alluvial soils and on rock. Explosives were used to induce strong ground-motion for two experiments, one on rock and the other on alluvium. A third experiment, a one-fourth scale containment structure on saturated alluvium, relies on earthquakes as the energy source. Analysis of the explosion-induced SSI data shows a marked shift in the fundamental frequency of the soil-structure system to a lower frequency. The magnitude of the shift is a function of foundation conditions and level of excitation. Analytical simulation was found to require more sophisticated soil constitutive models and computer codes than are used in current practice. The current phase of the program concentrates on evaluating SSI models used in current design practice by comparing predicted with recorded data at points in the soil-structure system. (author)

  2. Collaborative translational research leading to multicenter clinical trials in Duchenne muscular dystrophy: the Cooperative International Neuromuscular Research Group (CINRG).

    Science.gov (United States)

    Escolar, Diana M; Henricson, Erik K; Pasquali, Livia; Gorni, Ksenija; Hoffman, Eric P

    2002-10-01

    Progress in the development of rationally based therapies for Duchenne muscular dystrophy has been accelerated by encouraging multidisciplinary, multi-institutional collaboration between basic science and clinical investigators in the Cooperative International Research Group. We combined existing research efforts in pathophysiology by a gene expression profiling laboratory with the efforts of animal facilities capable of conducting high-throughput drug screening and toxicity testing to identify safe and effective drug compounds that target different parts of the pathophysiologic cascade in a genome-wide drug discovery approach. Simultaneously, we developed a clinical trial coordinating center and an international network of collaborating physicians and clinics where those drugs could be tested in large-scale clinical trials. We hope that by bringing together investigators at these facilities and providing the infrastructure to support their research, we can rapidly move new bench discoveries through animal model screening and into therapeutic testing in humans in a safe, timely and cost-effective setting.

  3. Developing a clinical trial unit to advance research in an academic institution.

    Science.gov (United States)

    Croghan, Ivana T; Viker, Steven D; Limper, Andrew H; Evans, Tamara K; Cornell, Alissa R; Ebbert, Jon O; Gertz, Morie A

    2015-11-01

    Research, clinical care, and education are the three cornerstones of academic health centers in the United States. The research climate has always been riddled with ebbs and flows, depending on funding availability. During a time of reduced funding, the number and scope of research studies have been reduced, and in some instances, a field of study has been eliminated. Recent reductions in the research funding landscape have led institutions to explore new ways to continue supporting research. Mayo Clinic in Rochester, MN has developed a clinical trial unit within the Department of Medicine, which provides shared resources for many researchers and serves as a solution for training and mentoring new investigators and study teams. By building on existing infrastructure and providing supplemental resources to existing research, the Department of Medicine clinical trial unit has evolved into an effective mechanism for conducting research. This article discusses the creation of a central unit to provide research support in clinical trials and presents the advantages, disadvantages, and required building blocks for such a unit. Copyright © 2015 Mayo Clinic. Published by Elsevier Inc. All rights reserved.

  4. Big-pharmaceuticalisation: clinical trials and Contract Research Organisations in India.

    Science.gov (United States)

    Sariola, Salla; Ravindran, Deapica; Kumar, Anand; Jeffery, Roger

    2015-04-01

    The World Trade Organisation's Trade Related Intellectual Property Rights [TRIPS] agreement aimed to harmonise intellectual property rights and patent protection globally. In India, the signing of this agreement resulted in a sharp increase in clinical trials since 2005. The Indian government, along with larger Indian pharmaceutical companies, believed that they could change existing commercial research cultures through the promotion of basic research as well as attracting international clinical trials, and thus create an international level, innovation-based drug industry. The effects of the growth of these outsourced and off-shored clinical trials on local commercial knowledge production in India are still unclear. What has been the impact of the increasing scale and commercialisation of clinical research on corporate science in India? In this paper we describe Big-pharmaceuticalisation in India, whereby the local pharmaceutical industry is moving from generic manufacturing to innovative research. Using conceptual frameworks of pharmaceuticalisation and innovation, this paper analyses data from research conducted in 2010-2012 and describes how Contract Research Organisations (CROs) enable outsourcing of randomised control trials to India. Focussing on twenty-five semi-structured interviews CRO staff, we chart the changes in Indian pharmaceutical industry, and implications for local research cultures. We use Big-pharmaceuticalisation to extend the notion of pharmaceuticalisation to describe the spread of pharmaceutical research globally and illustrate how TRIPS has encouraged a concentration of capital in India, with large companies gaining increasing market share and using their market power to rewrite regulations and introduce new regulatory practices in their own interest. Contract Research Organisations, with relevant, new, epistemic skills and capacities, are both manifestations of the changes in commercial research cultures, as well as the vehicles to

  5. Bureaucracy stifles medical research in Britain: a tale of three trials.

    Science.gov (United States)

    Snooks, Helen; Hutchings, Hayley; Seagrove, Anne; Stewart-Brown, Sarah; Williams, John; Russell, Ian

    2012-08-16

    Recent developments aiming to standardise and streamline processes of gaining the necessary approvals to carry out research in the National Health Service (NHS) in the United Kingdom (UK), have resulted in lengthy and costly delays. The national UK governmental Department of Health's Research Governance Framework (RGF) for Health and Social Care requires that appropriate checks be conducted before research involving human participants, their organs, tissues or data can commence in the NHS. As a result, medical research has been subjected to increased regulation and governance, with the requirement for approvals from numerous regulatory and monitoring bodies. In addition, the processes and outcomes of the attribution of costs in NHS research have caused additional difficulties for researchers. The purpose of this paper is to illustrate, through three trial case studies, the difficulties encountered during the set-up and recruitment phases of these trials, related to gaining the necessary ethical and governance approvals and applying for NHS costs to undertake and deliver the research. Empirical evidence about delays and difficulties related to regulation and governance of medical research was gathered during the period 2009-2010 from three UK randomised controlled trials with sites in England, Wales and Scotland (1. SAFER 2- an emergency care based trial of a protocol for paramedics to refer patients directly to community based falls services; 2. COnStRUCT- a trial of two drugs for acute ulcerative colitis; and 3. Family Links - a trial of a public health intervention, a 10 week community based parenting programme). Findings and recommendations were reported in response to a call for evidence from The Academy of Medical Sciences regarding difficulties encountered in conducting medical research arising from R&D governance and regulation, to inform national policy. Difficulties and delays in navigating and gaining the appropriate approvals and NHS costs required to

  6. The Globalization of Pediatric Research: An Analysis of Clinical Trials Completed for Pediatric Exclusivity

    Science.gov (United States)

    Pasquali, Sara K.; Burstein, Danielle S.; Benjamin, Daniel K.; Smith, P. Brian; Li, Jennifer S.

    2010-01-01

    Background Recent studies have examined the globalization of clinical research. These studies focused on adult trials, and the globalization of pediatric research has not been examined to date. We evaluated the setting of published studies conducted under the US Pediatric Exclusivity Program, which provides economic incentives to pharmaceutical companies to conduct drug studies in children. Methods Published studies containing the main results of trials conducted from 1998–2007 under the Pediatric Exclusivity Provision were included. Data were extracted from each study and described, including the therapeutic area of drug studied, number of patients enrolled, number of sites, and location where the study was conducted, if reported. Results Overall, 174 trials were included (sample size 8–27,065 patients); 9% did not report any information regarding the location or number of sites where the study was conducted. Of those that did report this information, 65% were conducted in at least one country outside the US, and 11% did not have any sites in the US. Fifty-four different countries were represented and 38% of trials enrolled patients in at least one site located in a developing/transition country, including more than one third of infectious disease, cardiovascular, and allergy/immunology trials. Conclusions The majority of published pediatric trials conducted under the Pediatric Exclusivity Provision included sites outside of the US, and over a third of trials enrolled patients in developing/transition countries. While there are many potential benefits to the globalization of pediatric research, this trend also raises certain scientific and ethical concerns which require further evaluation. PMID:20732941

  7. Randomised controlled trials of veterinary homeopathy: characterising the peer-reviewed research literature for systematic review.

    Science.gov (United States)

    Mathie, Robert T; Hacke, Daniela; Clausen, Jürgen

    2012-10-01

    Systematic review of the research evidence in veterinary homeopathy has never previously been carried out. This paper presents the search methods, together with categorised lists of retrieved records, that enable us to identify the literature that is acceptable for future systematic review of randomised controlled trials (RCTs) in veterinary homeopathy. All randomised and controlled trials of homeopathic intervention (prophylaxis and/or treatment of disease, in any species except man) were appraised according to pre-specified criteria. The following databases were systematically searched from their inception up to and including March 2011: AMED; Carstens-Stiftung Homeopathic Veterinary Clinical Research (HomVetCR) database; CINAHL; Cochrane Central Register of Controlled Trials; Embase; Hom-Inform; LILACS; PubMed; Science Citation Index; Scopus. One hundred and fifty records were retrieved; 38 satisfied the acceptance criteria (substantive report of a clinical treatment or prophylaxis trial in veterinary homeopathic medicine randomised and controlled and published in a peer-reviewed journal), and were thus eligible for future planned systematic review. Approximately half of the rejected records were theses. Seven species and 27 different species-specific medical conditions were represented in the 38 papers. Similar numbers of papers reported trials of treatment and prophylaxis (n=21 and n=17 respectively) and were controlled against placebo or other than placebo (n=18, n=20 respectively). Most research focused on non-individualised homeopathy (n=35 papers) compared with individualised homeopathy (n=3). The results provide a complete and clarified view of the RCT literature in veterinary homeopathy. We will systematically review the 38 substantive peer-reviewed journal articles under the main headings: treatment trials; prophylaxis trials. Copyright © 2012 The Faculty of Homeopathy. Published by Elsevier Ltd. All rights reserved.

  8. Improving publication rates in a collaborative clinical trials research network

    Science.gov (United States)

    Archer, Stephanie Wilson; Carlo, Waldemar A.; Truog, William E.; Stevenson, David K.; Van Meurs, Krisa P.; Sánchez, Pablo J.; Das, Abhik; Devaskar, Uday; Nelin, Leif D.; Petrie Huitema, Carolyn M.; Crawford, Margaret M.; Higgins, Rosemary D.

    2016-01-01

    Unpublished results can bias biomedical literature, favoring positive over negative findings, primary over secondary analyses, and can lead to duplicate studies that unnecessarily endanger subjects and waste resources. The Neonatal Research Network’s (NRN) publication policies for approving, reviewing, and tracking abstracts and papers work to combat these problems. In 2003, the NRN restricted investigators with unfinished manuscripts from proposing new ones and in 2010, urged authors to complete long-outstanding manuscripts. Data from 1991 to 2015 were analyzed to determine effectiveness of these policy changes. The NRN has achieved an overall publication rate of 78% for abstracts. For 1990–2002, of 137 abstracts presented, 43 (31%) were published within 2 years; for 2003–2009, after the manuscript completion policy was instituted, of 140 abstracts presented, 68 (49%) were published within 2 years. Following the effort in 2010, the rate increased to 64%. The NRN surpassed reported rates by developing a comprehensive process, holding investigators accountable and tracking abstracts from presentation to publication. PMID:27423510

  9. Verification of the numerical model of insert-type joint of scaffolding in relation to experimental research

    Science.gov (United States)

    Pieńko, Michał; Błazik-Borowa, Ewa

    2018-01-01

    This paper presents the problem of comparing the results of computer simulations with the results of laboratory tests. The subject of the study was the insert-type joint of scaffolding loaded with a bending moment. The research was carried out on the real elements of the scaffolding. Due to the complexity of the connection different friction coefficients and depths of wedge insertion were taken into account in the analysis. The aim of conducting the series of analyses was to determine the sensitivity of the model to the mentioned characteristics. Since laboratory tests were carried out on the real samples, there were no preparations of surface involved in the load transfer. This approach caused many problems with the clear definition of the nature of work of individual node elements during the load. The analysis consist of two stages: the stage in which the connection is defined (the wedge is inserted into the rosette), and the loading stage (the node is loaded by the bending moment).

  10. The trials methodological research agenda: results from a priority setting exercise

    Science.gov (United States)

    2014-01-01

    Background Research into the methods used in the design, conduct, analysis, and reporting of clinical trials is essential to ensure that effective methods are available and that clinical decisions made using results from trials are based on the best available evidence, which is reliable and robust. Methods An on-line Delphi survey of 48 UK Clinical Research Collaboration registered Clinical Trials Units (CTUs) was undertaken. During round one, CTU Directors were asked to identify important topics that require methodological research. During round two, their opinion about the level of importance of each topic was recorded, and during round three, they were asked to review the group’s average opinion and revise their previous opinion if appropriate. Direct reminders were sent to maximise the number of responses at each round. Results are summarised using descriptive methods. Results Forty one (85%) CTU Directors responded to at least one round of the Delphi process: 25 (52%) responded in round one, 32 (67%) responded in round two, 24 (50%) responded in round three. There were only 12 (25%) who responded to all three rounds and 18 (38%) who responded to both rounds two and three. Consensus was achieved amongst CTU Directors that the top three priorities for trials methodological research were ‘Research into methods to boost recruitment in trials’ (considered the highest priority), ‘Methods to minimise attrition’ and ‘Choosing appropriate outcomes to measure’. Fifty other topics were included in the list of priorities and consensus was reached that two topics, ‘Radiotherapy study designs’ and ‘Low carbon trials’, were not priorities. Conclusions This priority setting exercise has identified the research topics felt to be most important to the key stakeholder group of Directors of UKCRC registered CTUs. The use of robust methodology to identify these priorities will help ensure that this work informs the trials methodological research agenda, with

  11. Clinical Trials

    Medline Plus

    Full Text Available ... take part in a clinical trial. When researchers think that a trial's potential risks are greater than ... care costs for clinical trials. If you're thinking about taking part in a clinical trial, find ...

  12. Physics Verification Overview

    Energy Technology Data Exchange (ETDEWEB)

    Doebling, Scott William [Los Alamos National Lab. (LANL), Los Alamos, NM (United States)

    2017-09-12

    The purpose of the verification project is to establish, through rigorous convergence analysis, that each ASC computational physics code correctly implements a set of physics models and algorithms (code verification); Evaluate and analyze the uncertainties of code outputs associated with the choice of temporal and spatial discretization (solution or calculation verification); and Develop and maintain the capability to expand and update these analyses on demand. This presentation describes project milestones.

  13. Understanding and Improving Recruitment to Randomised Controlled Trials: Qualitative Research Approaches.

    Science.gov (United States)

    Elliott, Daisy; Husbands, Samantha; Hamdy, Freddie C; Holmberg, Lars; Donovan, Jenny L

    2017-11-01

    The importance of evidence from randomised trials is now widely recognised, although recruitment is often difficult. Qualitative research has shown promise in identifying the key barriers to recruitment, and interventions have been developed to reduce organisational difficulties and support clinicians undertaking recruitment. This article provides an introduction to qualitative research techniques and explains how this approach can be used to understand-and subsequently improve-recruitment and informed consent within a range of clinical trials. A literature search was performed using Medline, Embase, and CINAHL. All studies with qualitative research methods that focused on the recruitment activity of clinicians were included in the review. The majority of studies reported that organisational difficulties and lack of time for clinical staff were key barriers to recruitment. However, a synthesis of qualitative studies highlighted the intellectual and emotional challenges that arise when combining research with clinical roles, particularly in relation to equipoise and patient eligibility. To support recruiters to become more comfortable with the design and principles of randomised controlled trials, interventions have been developed, including the QuinteT Recruitment Intervention, which comprises in-depth investigation of recruitment obstacles in real time, followed by implementation of tailored strategies to address these challenges as the trial proceeds. Qualitative research can provide important insights into the complexities of recruitment to trials and inform the development of interventions, and provide support and training initiatives as required. Investigators should consider implementing such methods in trials expected to be challenging or recruiting below target. Qualitative research is a term used to describe a range of methods that can be implemented to understand participants' perspectives and behaviours. Data are gathered from interviews, focus groups

  14. Verification of safety critical software

    International Nuclear Information System (INIS)

    Son, Ki Chang; Chun, Chong Son; Lee, Byeong Joo; Lee, Soon Sung; Lee, Byung Chai

    1996-01-01

    To assure quality of safety critical software, software should be developed in accordance with software development procedures and rigorous software verification and validation should be performed. Software verification is the formal act of reviewing, testing of checking, and documenting whether software components comply with the specified requirements for a particular stage of the development phase[1]. New software verification methodology was developed and was applied to the Shutdown System No. 1 and 2 (SDS1,2) for Wolsung 2,3 and 4 nuclear power plants by Korea Atomic Energy Research Institute(KAERI) and Atomic Energy of Canada Limited(AECL) in order to satisfy new regulation requirements of Atomic Energy Control Boars(AECB). Software verification methodology applied to SDS1 for Wolsung 2,3 and 4 project will be described in this paper. Some errors were found by this methodology during the software development for SDS1 and were corrected by software designer. Outputs from Wolsung 2,3 and 4 project have demonstrated that the use of this methodology results in a high quality, cost-effective product. 15 refs., 6 figs. (author)

  15. Inspector measurement verification activities

    International Nuclear Information System (INIS)

    George, R.S.; Crouch, R.

    e most difficult and complex activity facing a safeguards inspector involves the verification of measurements and the performance of the measurement system. Remeasurement is the key to measurement verification activities. Remeasurerements using the facility's measurement system provide the bulk of the data needed for determining the performance of the measurement system. Remeasurements by reference laboratories are also important for evaluation of the measurement system and determination of systematic errors. The use of these measurement verification activities in conjunction with accepted inventory verification practices provides a better basis for accepting or rejecting an inventory. (U.S.)

  16. Research Article ( New England Journal of Medicine ) A trial of a 7 ...

    African Journals Online (AJOL)

    Research Article (New England Journal of Medicine) A trial of a 7-valent pneumococcal conjugate vaccine in HIV-infected adults. Neil French, Stephen B. Gordon, Thandie Mwalukomo, Sarah A. White, Gershom Mwafulirwa, Herbert Longwe, Martin Mwaiponya, Eduard E. Zijlstra, Malcolm E. Molyneux, Charles F. Gilks ...

  17. When referring physicians and researchers disagree on equipoise : the TOTAL trial experience

    NARCIS (Netherlands)

    Rodrigues, H. C. M. L.; Deprest, J.; v. d. Berg, P. P.

    Objective In this article, we reflect on whether randomized controlled trials (RCTs) are adequate for the clinical evaluation of maternal-fetal surgery for congenital diaphragmatic hernia (CDH), focusing on the role of patients' preferences in the setting up of research protocols, on the requirement

  18. Measures of outcome for stimulant trials: ACTTION recommendations and research agenda.

    Science.gov (United States)

    Kiluk, Brian D; Carroll, Kathleen M; Duhig, Amy; Falk, Daniel E; Kampman, Kyle; Lai, Shengan; Litten, Raye Z; McCann, David J; Montoya, Ivan D; Preston, Kenzie L; Skolnick, Phil; Weisner, Constance; Woody, George; Chandler, Redonna; Detke, Michael J; Dunn, Kelly; Dworkin, Robert H; Fertig, Joanne; Gewandter, Jennifer; Moeller, F Gerard; Ramey, Tatiana; Ryan, Megan; Silverman, Kenneth; Strain, Eric C

    2016-01-01

    The development and approval of an efficacious pharmacotherapy for stimulant use disorders has been limited by the lack of a meaningful indicator of treatment success, other than sustained abstinence. In March, 2015, a meeting sponsored by Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION) was convened to discuss the current state of the evidence regarding meaningful outcome measures in clinical trials for stimulant use disorders. Attendees included members of academia, funding and regulatory agencies, pharmaceutical companies, and healthcare organizations. The goal was to establish a research agenda for the development of a meaningful outcome measure that may be used as an endpoint in clinical trials for stimulant use disorders. Based on guidelines for the selection of clinical trial endpoints, the lessons learned from prior addiction clinical trials, and the process that led to identification of a meaningful indicator of treatment success for alcohol use disorders, several recommendations for future research were generated. These include a focus on the validation of patient reported outcome measures of functioning, the exploration of patterns of stimulant abstinence that may be associated with physical and/or psychosocial benefits, the role of urine testing for validating self-reported measures of stimulant abstinence, and the operational definitions for reduction-based measures in terms of frequency rather than quantity of stimulant use. These recommendations may be useful for secondary analyses of clinical trial data, and in the design of future clinical trials that may help establish a meaningful indicator of treatment success. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  19. Does clinical equipoise apply to cluster randomized trials in health research?

    Science.gov (United States)

    2011-01-01

    This article is part of a series of papers examining ethical issues in cluster randomized trials (CRTs) in health research. In the introductory paper in this series, Weijer and colleagues set out six areas of inquiry that must be addressed if the cluster trial is to be set on a firm ethical foundation. This paper addresses the third of the questions posed, namely, does clinical equipoise apply to CRTs in health research? The ethical principle of beneficence is the moral obligation not to harm needlessly and, when possible, to promote the welfare of research subjects. Two related ethical problems have been discussed in the CRT literature. First, are control groups that receive only usual care unduly disadvantaged? Second, when accumulating data suggests the superiority of one intervention in a trial, is there an ethical obligation to act? In individually randomized trials involving patients, similar questions are addressed by the concept of clinical equipoise, that is, the ethical requirement that, at the start of a trial, there be a state of honest, professional disagreement in the community of expert practitioners as to the preferred treatment. Since CRTs may not involve physician-researchers and patient-subjects, the applicability of clinical equipoise to CRTs is uncertain. Here we argue that clinical equipoise may be usefully grounded in a trust relationship between the state and research subjects, and, as a result, clinical equipoise is applicable to CRTs. Clinical equipoise is used to argue that control groups receiving only usual care are not disadvantaged so long as the evidence supporting the experimental and control interventions is such that experts would disagree as to which is preferred. Further, while data accumulating during the course of a CRT may favor one intervention over another, clinical equipoise supports continuing the trial until the results are likely to be broadly convincing, often coinciding with the planned completion of the trial

  20. Biochemical verification of the self-reported smoking status of screened male smokers of the Dutch-Belgian randomized controlled lung cancer screening trial.

    Science.gov (United States)

    van der Aalst, Carlijn M; de Koning, Harry J

    2016-04-01

    Smoking is the main cause of lung cancer, so data linked to smoking behaviour are important in lung cancer screening trials. However, self-reporting data concerning smoking behaviour are mainly used. The aim of this study was to biochemically determine the validity and reliability of self-reported smoking status among smokers at high risk for developing lung cancer participating in the Dutch-Belgian lung cancer screening (NELSON) trial. For this sub study, a random sample of 475 men was selected who were scheduled for the fourth screening round in the NELSON trial. They were asked to complete a short questionnaire to verify the smoking behaviour for the previous seven days and a blood sample was collected to measure the cotinine level. The validity (sensitivity (Se), specificity (Sp), positive predictive value (PPV), and negative predictive value (NPV)) and reliability (Kappa) of the self-reported smoking status compared to the cotinine level (as golden standard) were determined. Both a completed questionnaire as well as a cotinine level were available for 199 (41.9%) participants. Based on these data, Se and Sp were respectively 98% (95%-Confidence Interval (CI): 91-99) and 98% (95%-CI: 93-100). PPV and NPV were 98% and 96% and Kappa was 0.96. In conclusion, the validity of the self-reported smoking status turned out to be reliable amongst men at high risk for developing lung cancer who participate in the NELSON lung cancer screening trial. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  1. The N-of-1 Clinical Trial: A Timely Research Opportunity in Homeopathy.

    Science.gov (United States)

    Ulbrich-Zürni, Susanne; Teut, Michael; Roll, Stephanie; Mathie, Robert T

    2018-02-01

     The randomised controlled trial (RCT) is considered the 'gold standard' for establishing treatment efficacy or effectiveness of an intervention, but its data do not infer response in an individual patient. Individualised clinical care, a fundamental principle in complementary and alternative medicine (CAM), including homeopathy, seems well disposed in principle to being researched by single-patient (N-of-1) study design. Guidelines for reporting N-of-1 trials have recently been developed.  To overview the current status in the literature of the N-of-1 method and its application in medicine, including CAM. To consider whether the N-of-1 trial design offers an opportunity for novel research in homeopathy. N-OF-1 TRIAL DESIGN:  The N-of-1 trial applies the principles of the conventional crossover, blinded, RCT design. The treatment under study and the comparator are repeated in a randomised order, and with suitable washout time, over a defined period. N-of-1 design is constrained for use in chronic stable conditions, and for interventions that have quick onset and cessation of effect, with modest or negligible carryover. Outcome data can be aggregated and interpreted for the individual subject; they can also be pooled with data from several similar N-of-1 trials, enabling more generalisable conclusions. THE N-OF-1 TRIAL IN CAM: The typical individualisation of patient care can be accommodated in N-of-1 study design if the patient and the specific therapeutic intervention are selected within the constraints of the method. Application of the N-of-1 method in CAM has been advocated but has been mainly limited, in practice, to a small number of studies in herbal and traditional Chinese medicine. THE N-OF-1 TRIAL IN HOMEOPATHY:  Individualised homeopathy can be accommodated for investigation within the same methodological constraints; less in-depth homeopathic approaches to prescribing are also amendable to investigation using the N-of-1 method. No such studies

  2. Initiation of a phase-I trial of neutron capture therapy at the MIT research reactor

    International Nuclear Information System (INIS)

    Harling, O.K.; Bernard, J.A.; Yam, Chun-Shan

    1995-01-01

    The Massachusetts Institute of Technology (MIT), the New England Medical Center (NEMC), and Boston University Medical Center (BUMC) initiated a phase-1 trial of boron neutron capture therapy (BNCT) on September 6, 1994, at the 5-MW(thermal) MIT research reactor (MITR). A novel form of experimental cancer therapy, BNCT is being developed for certain types of highly malignant brain tumors such as glioblastoma and melanoma. The results of the phase-1 trials on patients with tumors in the legs or feet are described

  3. Importance of mixed methods in pragmatic trials and dissemination and implementation research.

    Science.gov (United States)

    Albright, Karen; Gechter, Katherine; Kempe, Allison

    2013-01-01

    With increased attention to the importance of translating research to clinical practice and policy, recent years have seen a proliferation of particular types of research, including pragmatic trials and dissemination and implementation research. Such research seeks to understand how and why interventions function in real-world settings, as opposed to highly controlled settings involving conditions not likely to be repeated outside the research study. Because understanding the context in which interventions are implemented is imperative for effective pragmatic trials and dissemination and implementation research, the use of mixed methods is critical to understanding trial results and the success or failure of implementation efforts. This article discusses a number of dimensions of mixed methods research, utilizing at least one qualitative method and at least one quantitative method, that may be helpful when designing projects or preparing grant proposals. Although the strengths and emphases of qualitative and quantitative approaches differ substantially, methods may be combined in a variety of ways to achieve a deeper level of understanding than can be achieved by one method alone. However, researchers must understand when and how to integrate the data as well as the appropriate order, priority, and purpose of each method. The ability to demonstrate an understanding of the rationale for and benefits of mixed methods research is increasingly important in today's competitive funding environment, and many funding agencies now expect applicants to include mixed methods in proposals. The increasing demand for mixed methods research necessitates broader methodological training and deepened collaboration between medical, clinical, and social scientists. Although a number of challenges to conducting and disseminating mixed methods research remain, the potential for insight generated by such work is substantial. Copyright © 2013 Academic Pediatric Association. Published by

  4. Pediatric Clinical Trials Conducted in South Korea from 2006 to 2015: An Analysis of the South Korean Clinical Research Information Service, US ClinicalTrials.gov and European Clinical Trials Registries.

    Science.gov (United States)

    Choi, Sheung-Nyoung; Lee, Ji-Hyun; Song, In-Kyung; Kim, Eun-Hee; Kim, Jin-Tae; Kim, Hee-Soo

    2017-12-01

    The status of pediatric clinical trials performed in South Korea in the last decade, including clinical trials of drugs with unapproved indications for children, has not been previously examined. The aim was to provide information regarding the current state of pediatric clinical trials and create a basis for future trials performed in South Korea by reviewing three databases of clinical trials registrations. We searched for pediatric clinical studies (participants South Korea between 2006 and 2015 registered on the Clinical Research Information Service (CRIS), ClinicalTrials.gov, and the European Clinical Trials Registry (EuCTR). Additionally, we reviewed whether unapproved indications were involved in each trial by comparing the trials with a list of authorized trials provided by the Ministry of Food and Drug Safety (MFDS). The primary and secondary outcomes were to determine the change in number of pediatric clinical trials with unapproved indications over time and to assess the status of unauthorized pediatric clinical trials from the MFDS and the publication of articles after these clinical trials, respectively. We identified 342 clinical studies registered in the CRIS (n = 81), ClinicalTrials.gov (n = 225), and EuCTR (n = 36), of which 306 were reviewed after excluding duplicate registrations. Among them, 181 studies were interventional trials dealing with drugs and biological agents, of which 129 (71.3%) involved unapproved drugs. Of these 129 trials, 107 (82.9%) were authorized by the MFDS. Pediatric clinical trials in South Korea aiming to establish the safety and efficacy of drugs in children are increasing; however, non-MFDS-authorized studies remain an issue.

  5. Telemedicine Provides Non-Inferior Research Informed Consent for Remote Study Enrollment: A Randomized Controlled Trial

    Science.gov (United States)

    Bobb, Morgan R.; Van Heukelom, Paul G.; Faine, Brett A.; Ahmed, Azeemuddin; Messerly, Jeffrey T.; Bell, Gregory; Harland, Karisa K.; Simon, Christian; Mohr, Nicholas M.

    2016-01-01

    Objective Telemedicine networks are beginning to provide an avenue for conducting emergency medicine research, but using telemedicine to recruit participants for clinical trials has not been validated. The goal of this consent study is to determine whether patient comprehension of telemedicine-enabled research informed consent is non-inferior to standard face-to-face research informed consent. Methods A prospective, open-label randomized controlled trial was performed in a 60,000-visit Midwestern academic Emergency Department (ED) to test whether telemedicine-enabled research informed consent provided non-inferior comprehension compared with standard consent. This study was conducted as part of a parent clinical trial evaluating the effectiveness of oral chlorhexidine gluconate 0.12% in preventing hospital-acquired pneumonia among adult ED patients with expected hospital admission. Prior to being recruited into the study, potential participants were randomized in a 1:1 allocation ratio to consent by telemedicine versus standard face-to-face consent. Telemedicine connectivity was provided using a commercially available interface (REACH platform, Vidyo Inc., Hackensack, NJ) to an emergency physician located in another part of the ED. Comprehension of research consent (primary outcome) was measured using the modified Quality of Informed Consent (QuIC) instrument, a validated tool for measuring research informed consent comprehension. Parent trial accrual rate and qualitative survey data were secondary outcomes. Results One-hundred thirty-one patients were randomized (n = 64, telemedicine), and 101 QuIC surveys were completed. Comprehension of research informed consent using telemedicine was not inferior to face-to-face consent (QuIC scores 74.4 ± 8.1 vs. 74.4 ± 6.9 on a 100-point scale, p = 0.999). Subjective understanding of consent (p=0.194) and parent trial study accrual rates (56% vs. 69%, p = 0.142) were similar. Conclusion Telemedicine is non-inferior to face

  6. Assessing the impact of user-centered research on a clinical trial eHealth tool via counterbalanced research design.

    Science.gov (United States)

    Atkinson, Nancy L; Massett, Holly A; Mylks, Christy; McCormack, Lauren A; Kish-Doto, Julia; Hesse, Bradford W; Wang, Min Qi

    2011-01-01

    Informatics applications have the potential to improve participation in clinical trials, but their design must be based on user-centered research. This research used a fully counterbalanced experimental design to investigate the effect of changes made to the original version of a website, http://BreastCancerTrials.org/, and confirm that the revised version addressed and reinforced patients' needs and expectations. Participants included women who had received a breast cancer diagnosis within the last 5 years (N=77). They were randomized into two groups: one group used and reviewed the original version first followed by the redesigned version, and the other group used and reviewed them in reverse order. The study used both quantitative and qualitative measures. During use, participants' click paths and general reactions were observed. After use, participants were asked to answer survey items and open-ended questions to indicate their reactions and which version they preferred and met their needs and expectations better. Overall, the revised version of the site was preferred and perceived to be clearer, easier to navigate, more trustworthy and credible, and more private and safe overall. However, users who viewed the original version last had similar attitudes toward both versions. By applying research findings to the redesign of a website for clinical trial searching, it was possible to re-engineer the interface to better support patients' decisions to participate in clinical trials. The mechanisms of action in this case appeared to revolve around creating an environment that supported a sense of personal control and decisional autonomy.

  7. Achievement report for fiscal 1999 on project for supporting the formation of energy/environmental technology verification project. International joint verification research project (Verification project relative to ignition and NOx reduction using plasma sub-burner in pulverized coal-fired furnace); 1999 nendo plasma sabubana ni yoru bifuntan nenshoro ni okeru chakka oyobi NO{sub x} teigen gijutsu ni kansuru jissho project seika hokokusho

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2000-03-01

    This project is executed through the cooperation of a Russian research institute, Akita Prefectural University, and the Ishikawajima-Harima Heavy Industries Co., Ltd. In the development of a plasma sub-burner and the basic research for its verification, a pulverized coal burning plasma sub-burner is designed and fabricated, a basic burning experiment is conducted for the plasma sub-burner, and plasma stabilization in a pulverized coal flow is simulated. In the verification study of the ignition by the plasma sub-burner in a pulverized coal-fired furnace, it is found that the newly-developed plasma sub-burner satisfies the prescribed operating conditions in the system and that the ignition of pulverized coal takes place across the air ratio range of 0.5-1.5 when pulverized coal is fed to the sub-burner. It is also found that NOx is reduced a great deal when a plasma operating on an orifice gas of air or nitrogen is generated in a gas which contains NOx. (NEDO)

  8. Clinical Trials

    Medline Plus

    Full Text Available ... Clinical Trials About Clinical Trials Clinical trials are research studies that explore whether a medical strategy, treatment, ... required to have an IRB. Office for Human Research Protections The U.S. Department of Health and Human ...

  9. Clinical Trials

    Medline Plus

    Full Text Available ... or device is safe and effective for humans. What Are Clinical Trials? Clinical trials are research studies ... parents, clinicians, researchers, children, and the general public. What to Expect During a clinical trial, doctors, nurses, ...

  10. ENVIRONMENTAL TECHNOLOGY VERIFICATION: TEST/QA PLAN FOR THE VERIFICATION TESTING OF SELECTIVE CATALYTIC REDUCTION CONTROL TECHNOLOGIES FOR HIGHWAY, NONROAD, AND STATIONARY USE DIESEL ENGINES

    Science.gov (United States)

    The U.S. Environmental Protection Agency established the Environmental Technology Verification Program to accelerate the development and commercialization of improved environmental technology through third party verification and reporting of product performance. Research Triangl...

  11. Verification Account Management System (VAMS)

    Data.gov (United States)

    Social Security Administration — The Verification Account Management System (VAMS) is the centralized location for maintaining SSA's verification and data exchange accounts. VAMS account management...

  12. The TLRR II – Providing Digital Infrastructure to Research Roman Republican Trials

    Directory of Open Access Journals (Sweden)

    Kirsten Jahn

    2016-12-01

    Full Text Available The project Trials in the Late Roman Republic II (TLRR II aims at collecting, organizing, and analyzing information about Roman legal cases in an XML database. M. Alexander published the book “Trials in the Late Roman Republic, 149 BC to 50 BC” (TLRR I in 1990, and initiated the current project that will make Roman republican trials easily accessible with modern technology. For each case a short description is provided, a clear distinction between assumptions and facts is made, and an updated bibliography can be found at the end of each entry. The open access database can serve both as a reference work and as a starting point for further research in Roman Republican history. It could be a connecting link within the developing digital infrastructure for that era.

  13. Return of individual research results and incidental findings in the clinical trials cooperative group setting.

    Science.gov (United States)

    Ferriere, Michael; Van Ness, Brian

    2012-04-01

    The National Cancer Institute (NCI)-funded cooperative group cancer clinical trial system develops experimental therapies and often collects samples from patients for correlative research. The cooperative group bank (CGB) system maintains biobanks with a current policy not to return research results to individuals. An online survey was created, and 10 directors of CGBs completed the surveys asking about understanding and attitudes in changing policies to consider return of incidental findings (IFs) and individual research results (IRRs) of health significance. The potential impact of the 10 consensus recommendations of Wolf et al. presented in this issue are examined. Reidentification of samples is often not problematic; however, changes to the current banking and clinical trial systems would require significant effort to fulfill an obligation of recontact of subjects. Additional resources, as well as a national advisory board would be required to standardize implementation.

  14. South African Research Ethics Committee Review of Standards of Prevention in HIV Vaccine Trial Protocols.

    Science.gov (United States)

    Essack, Zaynab; Wassenaar, Douglas R

    2018-04-01

    HIV prevention trials provide a prevention package to participants to help prevent HIV acquisition. As new prevention methods are proven effective, this raises ethical and scientific design complexities regarding the prevention package or standard of prevention. Given its high HIV incidence and prevalence, South Africa has become a hub for HIV prevention research. For this reason, it is critical to study the implementation of relevant ethical-legal frameworks for such research in South Africa. This qualitative study used in-depth interviews to explore the practices and perspectives of eight members of South African research ethics committees (RECs) who have reviewed protocols for HIV vaccine trials. Their practices and perspectives are compared with ethics guideline requirements for standards of prevention.

  15. Verification and the safeguards legacy

    International Nuclear Information System (INIS)

    Perricos, Demetrius

    2001-01-01

    A number of inspection or monitoring systems throughout the world over the last decades have been structured drawing upon the IAEA experience of setting up and operating its safeguards system. The first global verification system was born with the creation of the IAEA safeguards system, about 35 years ago. With the conclusion of the NPT in 1968, inspections were to be performed under safeguards agreements, concluded directly between the IAEA and non-nuclear weapon states parties to the Treaty. The IAEA developed the safeguards system within the limitations reflected in the Blue Book (INFCIRC 153), such as limitations of routine access by the inspectors to 'strategic points', including 'key measurement points', and the focusing of verification on declared nuclear material in declared installations. The system, based as it was on nuclear material accountancy. It was expected to detect a diversion of nuclear material with a high probability and within a given time and therefore determine also that there had been no diversion of nuclear material from peaceful purposes. The most vital element of any verification system is the inspector. Technology can assist but cannot replace the inspector in the field. Their experience, knowledge, intuition and initiative are invaluable factors contributing to the success of any inspection regime. The IAEA inspectors are however not part of an international police force that will intervene to prevent a violation taking place. To be credible they should be technically qualified with substantial experience in industry or in research and development before they are recruited. An extensive training program has to make sure that the inspectors retain their professional capabilities and that it provides them with new skills. Over the years, the inspectors and through them the safeguards verification system gained experience in: organization and management of large teams; examination of records and evaluation of material balances

  16. Research design considerations for chronic pain prevention clinical trials: IMMPACT recommendations.

    Science.gov (United States)

    Gewandter, Jennifer S; Dworkin, Robert H; Turk, Dennis C; Farrar, John T; Fillingim, Roger B; Gilron, Ian; Markman, John D; Oaklander, Anne Louise; Polydefkis, Michael J; Raja, Srinivasa N; Robinson, James P; Woolf, Clifford J; Ziegler, Dan; Ashburn, Michael A; Burke, Laurie B; Cowan, Penney; George, Steven Z; Goli, Veeraindar; Graff, Ole X; Iyengar, Smriti; Jay, Gary W; Katz, Joel; Kehlet, Henrik; Kitt, Rachel A; Kopecky, Ernest A; Malamut, Richard; McDermott, Michael P; Palmer, Pamela; Rappaport, Bob A; Rauschkolb, Christine; Steigerwald, Ilona; Tobias, Jeffrey; Walco, Gary A

    2015-07-01

    Although certain risk factors can identify individuals who are most likely to develop chronic pain, few interventions to prevent chronic pain have been identified. To facilitate the identification of preventive interventions, an IMMPACT meeting was convened to discuss research design considerations for clinical trials investigating the prevention of chronic pain. We present general design considerations for prevention trials in populations that are at relatively high risk for developing chronic pain. Specific design considerations included subject identification, timing and duration of treatment, outcomes, timing of assessment, and adjusting for risk factors in the analyses. We provide a detailed examination of 4 models of chronic pain prevention (ie, chronic postsurgical pain, postherpetic neuralgia, chronic low back pain, and painful chemotherapy-induced peripheral neuropathy). The issues discussed can, in many instances, be extrapolated to other chronic pain conditions. These examples were selected because they are representative models of primary and secondary prevention, reflect persistent pain resulting from multiple insults (ie, surgery, viral infection, injury, and toxic or noxious element exposure), and are chronically painful conditions that are treated with a range of interventions. Improvements in the design of chronic pain prevention trials could improve assay sensitivity and thus accelerate the identification of efficacious interventions. Such interventions would have the potential to reduce the prevalence of chronic pain in the population. Additionally, standardization of outcomes in prevention clinical trials will facilitate meta-analyses and systematic reviews and improve detection of preventive strategies emerging from clinical trials.

  17. Impact of individual clinical outcomes on trial participants' perspectives on enrollment in emergency research without consent.

    Science.gov (United States)

    Whitesides, Louisa W; Baren, Jill M; Biros, Michelle H; Fleischman, Ross J; Govindarajan, Prasanthi R; Jones, Elizabeth B; Pancioli, Arthur M; Pentz, Rebecca D; Scicluna, Victoria M; Wright, David W; Dickert, Neal W

    2017-04-01

    Evidence suggests that patients are generally accepting of their enrollment in trials for emergency care conducted under exception from informed consent. It is unknown whether individuals with more severe initial injuries or worse clinical outcomes have different perspectives. Determining whether these differences exist may help to structure post-enrollment interactions. Primary clinical data from the Progesterone for the Treatment of Traumatic Brain Injury trial were matched to interview data from the Patients' Experiences in Emergency Research-Progesterone for the Treatment of Traumatic Brain Injury study. Answers to three key questions from Patients' Experiences in Emergency Research-Progesterone for the Treatment of Traumatic Brain Injury study were analyzed in the context of enrolled patients' initial injury severity (initial Glasgow Coma Scale and Injury Severity Score) and principal clinical outcomes (Extended Glasgow Outcome Scale and Extended Glasgow Outcome Scale relative to initial injury severity). The three key questions from Patients' Experiences in Emergency Research-Progesterone for the Treatment of Traumatic Brain Injury study addressed participants' general attitude toward inclusion in the Progesterone for the Treatment of Traumatic Brain Injury trial (general trial inclusion), their specific attitude toward being included in Progesterone for the Treatment of Traumatic Brain Injury trial under the exception from informed consent (personal exception from informed consent enrollment), and their attitude toward the use of exception from informed consent in the Progesterone for the Treatment of Traumatic Brain Injury trial in general (general exception from informed consent enrollment). Qualitative analysis of interview transcripts was performed to provide contextualization and to determine the extent to which respondents framed their attitudes in terms of clinical experience. Clinical data from Progesterone for the Treatment of Traumatic Brain Injury

  18. Enhancing the informed consent process for critical care research: strategies from a thromboprophylaxis trial.

    Science.gov (United States)

    Smith, Orla M; McDonald, Ellen; Zytaruk, Nicole; Foster, Denise; Matte, Andrea; Clarke, France; Fleury, Suzie; Krause, Katie; McArdle, Tracey; Skrobik, Yoanna; Cook, Deborah J

    2013-12-01

    Critically ill patients lack capacity for decisions about research participation. Consent to enrol these patients in studies is typically obtained from substitute decision-makers. To present strategies that may optimise the process of obtaining informed consent from substitute decision-makers for participation of critically ill patients in trials. We use examples from a randomised trial of heparin thromboprophylaxis in the intensive care unit (PROTECT, clinicaltrials.gov NCT00182143). 3764 patients were randomised, with an informed consent rate of 82%; 90% of consents were obtained from substitute decision-makers. North American PROTECT research coordinators attended three meetings to discuss enrolment: (1) Trial start-up (January 2006); (2) Near trial closure (January 2010); and (3) Post-publication (April 2011). Data were derived from slide presentations, field notes from break-out groups and plenary discussions, then analysed inductively. We derived three phases for the informed consent process: (1) Preparation for the Consent Encounter; (2) The Consent Encounter; and (3) Follow-up to the Consent Encounter. Specific strategies emerged for each phase: Phase 1 (four strategies); Phase 2 (six strategies); and Phase 3 (three strategies). We identified 13 strategies that may improve the process of obtaining informed consent from substitute decision-makers and be generalisable to other settings and studies. Copyright © 2013 The Authors. Published by Elsevier Ltd.. All rights reserved.

  19. Comparing formal verification approaches of interlocking systems

    DEFF Research Database (Denmark)

    Haxthausen, Anne Elisabeth; Nguyen, Hoang Nga; Roggenbach, Markus

    2016-01-01

    these approaches. As a first step towards this, in this paper we suggest a way to compare different formal approaches for verifying designs of route-based interlocking systems and we demonstrate it on modelling and verification approaches developed within the research groups at DTU/Bremen and at Surrey......The verification of railway interlocking systems is a challenging task, and therefore several research groups have suggested to improve this task by using formal methods, but they use different modelling and verification approaches. To advance this research, there is a need to compare....../Swansea. The focus is on designs that are specified by so-called control tables. The paper can serve as a starting point for further comparative studies. The DTU/Bremen research has been funded by the RobustRailS project granted by Innovation Fund Denmark. The Surrey/Swansea research has been funded by the Safe...

  20. FMCT verification: Case studies

    International Nuclear Information System (INIS)

    Hui Zhang

    2001-01-01

    Full text: How to manage the trade-off between the need for transparency and the concern about the disclosure of sensitive information would be a key issue during the negotiations of FMCT verification provision. This paper will explore the general concerns on FMCT verification; and demonstrate what verification measures might be applied to those reprocessing and enrichment plants. A primary goal of an FMCT will be to have the five declared nuclear weapon states and the three that operate unsafeguarded nuclear facilities become parties. One focus in negotiating the FMCT will be verification. Appropriate verification measures should be applied in each case. Most importantly, FMCT verification would focus, in the first instance, on these states' fissile material production facilities. After the FMCT enters into force, all these facilities should be declared. Some would continue operating to produce civil nuclear power or to produce fissile material for non- explosive military uses. The verification measures necessary for these operating facilities would be essentially IAEA safeguards, as currently being applied to non-nuclear weapon states under the NPT. However, some production facilities would be declared and shut down. Thus, one important task of the FMCT verifications will be to confirm the status of these closed facilities. As case studies, this paper will focus on the verification of those shutdown facilities. The FMCT verification system for former military facilities would have to differ in some ways from traditional IAEA safeguards. For example, there could be concerns about the potential loss of sensitive information at these facilities or at collocated facilities. Eventually, some safeguards measures such as environmental sampling might be seen as too intrusive. Thus, effective but less intrusive verification measures may be needed. Some sensitive nuclear facilities would be subject for the first time to international inspections, which could raise concerns

  1. Strategy for assessment of WWER steam generator tube integrity. Report prepared within the framework of the coordinated research project on verification of WWER steam generator tube integrity

    International Nuclear Information System (INIS)

    2007-12-01

    Steam generator heat exchanger tube degradations happen in WWER Nuclear Power Plant (NPP). The situation varies from country to country and from NPP to NPP. More severe degradation is observed in WWER-1000 NPPs than in case of WWER-440s. The reasons for these differences could be, among others, differences in heat exchanger tube material (chemical composition, microstructure, residual stresses), in thermal and mechanical loadings, as well as differences in water chemistry. However, WWER steam generators had not been designed for eddy current testing which is the usual testing method in steam generators of western PWRs. Moreover, their supplier provided neither adequate methodology and criteria nor equipment for planning and implementing In-Service Inspection (ISI). Consequently, WWER steam generator ISI infrastructure was established with delay. Even today, there are still big differences in the eddy current inspection strategy and practice as well as in the approach to steam generator heat exchanger tube structural integrity assessment (plugging criteria for defective tubes vary from 40 to 90% wall thickness degradation). Recognizing this situation, the WWER operating countries expressed their need for a joint effort to develop methodology to establish reasonable commonly accepted integrity assessment criteria for the heat exchanger tubes. The IAEA's programme related to steam generator life management is embedded into the systematic activity of its Technical Working Group on Life Management of Nuclear Power Plants (TWG-LMNPP). Under the advice of the TWG-LMNPP, an IAEA coordinated research project (CRP) on Verification of WWER Steam Generator Tube Integrity was launched in 2001. It was completed in 2005. Thirteen organizations involved in in-service inspection of steam generators in WWER operating countries participated: Croatia, Czech Republic, Finland, France, Hungary, Russian Federation, Slovakia, Spain, Ukraine, and the USA. The overall objective was to

  2. Advanced verification topics

    CERN Document Server

    Bhattacharya, Bishnupriya; Hall, Gary; Heaton, Nick; Kashai, Yaron; Khan Neyaz; Kirshenbaum, Zeev; Shneydor, Efrat

    2011-01-01

    The Accellera Universal Verification Methodology (UVM) standard is architected to scale, but verification is growing and in more than just the digital design dimension. It is growing in the SoC dimension to include low-power and mixed-signal and the system integration dimension to include multi-language support and acceleration. These items and others all contribute to the quality of the SOC so the Metric-Driven Verification (MDV) methodology is needed to unify it all into a coherent verification plan. This book is for verification engineers and managers familiar with the UVM and the benefits it brings to digital verification but who also need to tackle specialized tasks. It is also written for the SoC project manager that is tasked with building an efficient worldwide team. While the task continues to become more complex, Advanced Verification Topics describes methodologies outside of the Accellera UVM standard, but that build on it, to provide a way for SoC teams to stay productive and profitable.

  3. Proceeding of the workshop on the results of the cooperative research between JAERI and CHESCIR concerning the study on assessment and analysis of environmental radiological consequences and verification of an assessment system

    Energy Technology Data Exchange (ETDEWEB)

    Amano, Hikaru; Saito, Kimiaki (eds.) [Japan Atomic Energy Research Inst., Tokai, Ibaraki (Japan). Tokai Research Establishment

    2001-03-01

    This workshop was organized and sponsored by the Japan Atomic Energy Research Institute (JAERI) and Chernobyl Science and Technology Center for International Research (CHESCIR). JAERI and CHESCIR have conducted 8 years research cooperation from 1992 to 1999 concerning the study on assessment and analysis of environmental radiological consequences and verification of an assessment system, focusing on the Chernobyl contaminated area. It contained 3 research subjects. Subject-1 initiated at 1992 and focused the study on measurements and evaluation of environmental external exposure after nuclear accident. Subject-2 initiated at 1992 and focused the study on the validation of assessment models in an environmental consequence assessment methodology for nuclear accidents. Subject-3 initiated at 1995 and focused on the study on migration of radionuclides released into terrestrial and aquatic environment after nuclear accidents. This workshop was held to summarize the research cooperation between JAERI and CHESCIR, and to discuss future research needs in this field. (author)

  4. Should we embed randomized controlled trials within action research: arguing from a case study of telemonitoring

    Directory of Open Access Journals (Sweden)

    Karen Day

    2016-06-01

    Full Text Available Abstract Background Action research (AR and randomized controlled trials (RCTs are usually considered to be theoretically and practically incompatible. However, we argue that their respective strengths and weaknesses can be complementary. We illustrate our argument from a recent study assessing the effect of telemonitoring on health-related quality of life, self-care, hospital use, costs and the experiences of patients, informal carers and health care professionals in two urban hospital services and one remote rural primary care service in New Zealand. Methods Data came from authors’ observations and field notes of discussions with three groups: the healthcare providers and healthcare consumers who participated in the research, and a group of 17 researchers and collaborators. The consumers had heart failure (Site A, urban, airways disease (Site B, urban, and diabetes (Site C, rural. The research ran from 2008 (project inception until 2012 (project close-off. Researchers came from a wide range of disciplines. Both RCT and AR methods were recognised from early in the process but often worked in parallel rather than together. In retrospect, we have mapped our observed research processes to the AR cycle characteristics (creation of communicative space, democracy and participation, iterative learning and improvement, emergence, and accommodation of different ways of knowing. Results We describe the context, conduct and outcomes of the telemonitoring trial, framing the overall process in the language of AR. Although not fully articulated at the time, AR processes made the RCT sensitive to important context, e.g. clinical processes. They resulted in substantive changes to the design and conduct of the RCT, and to interpretation and uptake of findings, e.g. a simpler technology procurement process emerged. Creating a communicative space enabled co-design between the researcher group and collaborators from the provider participant group, and a stronger

  5. Clinical trial registries: a practical guide for sponsors and researchers of medicinal products

    National Research Council Canada - National Science Library

    Foote, MaryAnn

    2006-01-01

    ... Industry perspective on public clinical trial registries and results databases . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ...

  6. CYberinfrastructure for COmparative effectiveness REsearch (CYCORE): improving data from cancer clinical trials

    OpenAIRE

    Patrick, Kevin; Wolszon, Laura; Basen-Engquist, Karen M; Demark-Wahnefried, Wendy; Prokhorov, Alex V; Barrera, Stephanie; Baru, Chaitan; Farcas, Emilia; Krueger, Ingolf; Palmer, Doug; Raab, Fred; Rios, Phil; Ziftci, Celal; Peterson, Susan

    2010-01-01

    ABSTRACT Improved approaches and methodologies are needed to conduct comparative effectiveness research (CER) in oncology. While cancer therapies continue to emerge at a rapid pace, the review, synthesis, and dissemination of evidence-based interventions across clinical trials lag in comparison. Rigorous and systematic testing of competing therapies has been clouded by age-old problems: poor patient adherence, inability to objectively measure the environmental influences on health, lack of kn...

  7. Employing open/hidden administration in psychotherapy research: A randomized-controlled trial of expressive writing

    Science.gov (United States)

    Tondorf, Theresa; Kaufmann, Lisa-Katrin; Degel, Alexander; Locher, Cosima; Birkhäuer, Johanna; Gerger, Heike; Ehlert, Ulrike

    2017-01-01

    Psychotherapy has been shown to be effective, but efforts to prove specific effects by placebo-controlled trials have been practically and conceptually hampered. We propose that adopting open/hidden designs from placebo research would offer a possible way to establish specificity in psychotherapy. Therefore, we tested the effects of providing opposing treatment rationales in an online expressive writing intervention on affect in healthy subjects. Results indicate that it was possible to conduct the expressive writing intervention both covertly and openly, but that participants in the hidden administration condition did not fully benefit from the otherwise effective expressive writing intervention in the long-run. Effect sizes between open and hidden administration groups were comparable to pre-post effect sizes of the intervention. While this finding is important for the understanding of psychotherapy's effects per se, it also proves that alternative research approaches to establish specificity are feasible and informative in psychotherapy research. Trial registration: German Clinical Trials Register DRKS00009428 PMID:29176768

  8. Case Study: Test Results of a Tool and Method for In-Flight, Adaptive Control System Verification on a NASA F-15 Flight Research Aircraft

    Science.gov (United States)

    Jacklin, Stephen A.; Schumann, Johann; Guenther, Kurt; Bosworth, John

    2006-01-01

    Adaptive control technologies that incorporate learning algorithms have been proposed to enable autonomous flight control and to maintain vehicle performance in the face of unknown, changing, or poorly defined operating environments [1-2]. At the present time, however, it is unknown how adaptive algorithms can be routinely verified, validated, and certified for use in safety-critical applications. Rigorous methods for adaptive software verification end validation must be developed to ensure that. the control software functions as required and is highly safe and reliable. A large gap appears to exist between the point at which control system designers feel the verification process is complete, and when FAA certification officials agree it is complete. Certification of adaptive flight control software verification is complicated by the use of learning algorithms (e.g., neural networks) and degrees of system non-determinism. Of course, analytical efforts must be made in the verification process to place guarantees on learning algorithm stability, rate of convergence, and convergence accuracy. However, to satisfy FAA certification requirements, it must be demonstrated that the adaptive flight control system is also able to fail and still allow the aircraft to be flown safely or to land, while at the same time providing a means of crew notification of the (impending) failure. It was for this purpose that the NASA Ames Confidence Tool was developed [3]. This paper presents the Confidence Tool as a means of providing in-flight software assurance monitoring of an adaptive flight control system. The paper will present the data obtained from flight testing the tool on a specially modified F-15 aircraft designed to simulate loss of flight control faces.

  9. ‘Putting Life in Years’ (PLINY) telephone friendship groups research study: pilot randomised controlled trial

    Science.gov (United States)

    2014-01-01

    Background Loneliness in older people is associated with poor health-related quality of life (HRQoL). We undertook a parallel-group randomised controlled trial to evaluate the effectiveness and cost-effectiveness of telephone befriending for the maintenance of HRQoL in older people. An internal pilot tested the feasibility of the trial and intervention. Methods Participants aged >74 years, with good cognitive function, living independently in one UK city were recruited through general practices and other sources, then randomised to: (1) 6 weeks of short one-to-one telephone calls, followed by 12 weeks of group telephone calls with up to six participants, led by a trained volunteer facilitator; or (2) a control group. The main trial required the recruitment of 248 participants in a 1-year accrual window, of whom 124 were to receive telephone befriending. The pilot specified three success criteria which had to be met in order to progress the main trial to completion: recruitment of 68 participants in 95 days; retention of 80% participants at 6 months; successful delivery of telephone befriending by local franchise of national charity. The primary clinical outcome was the Short Form (36) Health Instrument (SF-36) Mental Health (MH) dimension score collected by telephone 6 months following randomisation. Results We informed 9,579 older people about the study. Seventy consenting participants were randomised to the pilot in 95 days, with 56 (80%) providing valid primary outcome data (26 intervention, 30 control). Twenty-four participants randomly allocated to the research arm actually received telephone befriending due to poor recruitment and retention of volunteer facilitators. The trial was closed early as a result. The mean 6-month SF-36 MH scores were 78 (SD 18) and 71 (SD 21) for the intervention and control groups, respectively (mean difference, 7; 95% CI, -3 to 16). Conclusions Recruitment and retention of participants to a definitive trial with a

  10. Sequential, Multiple Assignment, Randomized Trial Designs in Immuno-oncology Research.

    Science.gov (United States)

    Kidwell, Kelley M; Postow, Michael A; Panageas, Katherine S

    2018-02-15

    Clinical trials investigating immune checkpoint inhibitors have led to the approval of anti-CTLA-4 (cytotoxic T-lymphocyte antigen-4), anti-PD-1 (programmed death-1), and anti-PD-L1 (PD-ligand 1) drugs by the FDA for numerous tumor types. In the treatment of metastatic melanoma, combinations of checkpoint inhibitors are more effective than single-agent inhibitors, but combination immunotherapy is associated with increased frequency and severity of toxicity. There are questions about the use of combination immunotherapy or single-agent anti-PD-1 as initial therapy and the number of doses of either approach required to sustain a response. In this article, we describe a novel use of sequential, multiple assignment, randomized trial (SMART) design to evaluate immune checkpoint inhibitors to find treatment regimens that adapt within an individual based on intermediate response and lead to the longest overall survival. We provide a hypothetical example SMART design for BRAF wild-type metastatic melanoma as a framework for investigating immunotherapy treatment regimens. We compare implementing a SMART design to implementing multiple traditional randomized clinical trials. We illustrate the benefits of a SMART over traditional trial designs and acknowledge the complexity of a SMART. SMART designs may be an optimal way to find treatment strategies that yield durable response, longer survival, and lower toxicity. Clin Cancer Res; 24(4); 730-6. ©2017 AACR . ©2017 American Association for Cancer Research.

  11. Standard Verification System (SVS)

    Data.gov (United States)

    Social Security Administration — SVS is a mainframe program that accesses the NUMIDENT to perform SSN verifications. This program is called by SSA Internal applications to verify SSNs. There is also...

  12. Formal Verification -26 ...

    Indian Academy of Sciences (India)

    by testing of the components and successful testing leads to the software being ... Formal verification is based on formal methods which are mathematically based ..... scenario under which a similar error could occur. There are various other ...

  13. SSN Verification Service

    Data.gov (United States)

    Social Security Administration — The SSN Verification Service is used by Java applications to execute the GUVERF02 service using the WebSphere/CICS Interface. It accepts several input data fields...

  14. Environmental technology verification methods

    CSIR Research Space (South Africa)

    Szewczuk, S

    2016-03-01

    Full Text Available Environmental Technology Verification (ETV) is a tool that has been developed in the United States of America, Europe and many other countries around the world to help innovative environmental technologies reach the market. Claims about...

  15. Verification of RADTRAN

    International Nuclear Information System (INIS)

    Kanipe, F.L.; Neuhauser, K.S.

    1995-01-01

    This document presents details of the verification process of the RADTRAN computer code which was established for the calculation of risk estimates for radioactive materials transportation by highway, rail, air, and waterborne modes

  16. Research ethics committee decision-making in relation to an efficient neonatal trial.

    Science.gov (United States)

    Gale, C; Hyde, M J; Modi, N

    2017-07-01

    Randomised controlled trials, a gold-standard approach to reduce uncertainties in clinical practice, are growing in cost and are often slow to recruit. We determined whether methodological approaches to facilitate large, efficient clinical trials were acceptable to UK research ethics committees (RECs). We developed a protocol in collaboration with parents, for a comparative-effectiveness, randomised controlled trial comparing two widely used blood transfusion practices in preterm infants. We incorporated four approaches to improve recruitment and efficiency: (i) point-of-care design using electronic patient records for patient identification, randomisation and data acquisition, (ii) short two-page information sheet; (iii) explicit mention of possible inclusion benefit; (iv) opt-out consent with enrolment as the default. With the support of the UK Health Research Authority, we submitted an identical protocol to 12 UK REC. RECs in the UK. Number of REC granting favourable opinions. The use of electronic patient records was acceptable to all RECs; one REC raised concerns about the short parent information sheet, 10 about inclusion benefit and 9 about opt-out consent. Following responses to queries, nine RECs granted a favourable final opinion and three rejected the application because they considered the opt-out consent process invalid. A majority of RECs in this study consider the use of electronic patient record data, short information sheets, opt-out consent and mention of possible inclusion benefit to be acceptable in neonatal comparative-effectiveness research. We identified a need for guidance for RECs in relation to opt-out consent processes. These methods provide opportunity to facilitate large randomised controlled trials. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  17. Do Research Intermediaries Reduce Perceived Coercion to Enter Research Trials Among Criminally Involved Substance Abusers?

    Science.gov (United States)

    Festinger, David S; Dugosh, Karen L; Croft, Jason R; Arabia, Patricia L; Marlowe, Douglas B

    2011-01-01

    We examined the efficacy of including a research intermediary (RI) during the consent process in reducing participants' perceptions of coercion to enroll in a research study. Eighty-four drug court clients being recruited into an ongoing study were randomized to receive a standard informed consent process alone (standard condition) or with an RI (intermediary condition). Before obtaining consent, RIs met with clients individually to discuss remaining concerns. Findings provided preliminary evidence that RIs reduced client perceptions that their participation might influence how clinical and judicial staff view them. This suggests that using RIs may improve participant autonomy in clinical studies.

  18. Performance of a low cost single beam echosounder : in situ trials in a shallow water coral reef habitat with verification by video

    OpenAIRE

    Betanzos, A.; Martín, H.A.; Valle, S.; Tizol, R.; Schneider, P.; Hernández, J.L.; Brehmer, Patrice; Linares, E.O.; Guillard, J.; Hermand, J.P.

    2015-01-01

    In a context of potential overexploitation of fisheries resources in the Sabana-Camagüey Archipelago (Cuba), the Cuban national authorities have expressed the need to collect more in situ information on fish of commercial interest in spawning areas. A newly developed low cost single-beam scientific echosounder has been recently acquired by the Cuban Fisheries Research Centre (CIP). In this work, we provide first results of a comparative analysis carried out in the Sabana-Camagüey ...

  19. A Cluster-Randomized Trial of Restorative Practices: An Illustration to Spur High-Quality Research and Evaluation

    Science.gov (United States)

    Acosta, Joie D.; Chinman, Matthew; Ebener, Patricia; Phillips, Andrea; Xenakis, Lea; Malone, Patrick S.

    2016-01-01

    Restorative practices in schools lack rigorous evaluation studies. As an example of rigorous school-based research, this article describes the first randomized control trial of restorative practices to date, the Study of Restorative Practices. It is a 5-year, cluster-randomized controlled trial (RCT) of the Restorative Practices Intervention (RPI)…

  20. 'Putting Life in Years' (PLINY) telephone friendship groups research study: pilot randomised controlled trial.

    Science.gov (United States)

    Mountain, Gail A; Hind, Daniel; Gossage-Worrall, Rebecca; Walters, Stephen J; Duncan, Rosie; Newbould, Louise; Rex, Saleema; Jones, Carys; Bowling, Ann; Cattan, Mima; Cairns, Angela; Cooper, Cindy; Edwards, Rhiannon Tudor; Goyder, Elizabeth C

    2014-04-24

    Loneliness in older people is associated with poor health-related quality of life (HRQoL). We undertook a parallel-group randomised controlled trial to evaluate the effectiveness and cost-effectiveness of telephone befriending for the maintenance of HRQoL in older people. An internal pilot tested the feasibility of the trial and intervention. Participants aged >74 years, with good cognitive function, living independently in one UK city were recruited through general practices and other sources, then randomised to: (1) 6 weeks of short one-to-one telephone calls, followed by 12 weeks of group telephone calls with up to six participants, led by a trained volunteer facilitator; or (2) a control group. The main trial required the recruitment of 248 participants in a 1-year accrual window, of whom 124 were to receive telephone befriending. The pilot specified three success criteria which had to be met in order to progress the main trial to completion: recruitment of 68 participants in 95 days; retention of 80% participants at 6 months; successful delivery of telephone befriending by local franchise of national charity. The primary clinical outcome was the Short Form (36) Health Instrument (SF-36) Mental Health (MH) dimension score collected by telephone 6 months following randomisation. We informed 9,579 older people about the study. Seventy consenting participants were randomised to the pilot in 95 days, with 56 (80%) providing valid primary outcome data (26 intervention, 30 control). Twenty-four participants randomly allocated to the research arm actually received telephone befriending due to poor recruitment and retention of volunteer facilitators. The trial was closed early as a result. The mean 6-month SF-36 MH scores were 78 (SD 18) and 71 (SD 21) for the intervention and control groups, respectively (mean difference, 7; 95% CI, -3 to 16). Recruitment and retention of participants to a definitive trial with a recruitment window of 1 year is feasible. For

  1. A comparative analysis of quality management standards for contract research organisations in clinical trials.

    Science.gov (United States)

    Murray, Elizabeth; McAdam, Rodney

    2007-01-01

    This article compares and contrasts the main quality standards in the highly regulated pharmaceutical industry with specific focus on Good Clinical Practice (GCP), the standard for designing, conducting, recording and reporting clinical trials involving human participants. Comparison is made to ISO quality standards, which can be applied to all industries and types of organisation. The study is then narrowed to that of contract research organisations (CROs) involved in the conduct of clinical trials. The paper concludes that the ISO 9000 series of quality standards can act as a company-wide framework for quality management within such organisations by helping to direct quality efforts on a long-term basis without any loss of compliance. This study is valuable because comparative analysis in this domain is uncommon.

  2. Creating an African HIV clinical research and prevention trials network: HIV prevalence, incidence and transmission.

    Directory of Open Access Journals (Sweden)

    Anatoli Kamali

    Full Text Available HIV epidemiology informs prevention trial design and program planning. Nine clinical research centers (CRC in sub-Saharan Africa conducted HIV observational epidemiology studies in populations at risk for HIV infection as part of an HIV prevention and vaccine trial network. Annual HIV incidence ranged from below 2% to above 10% and varied by CRC and risk group, with rates above 5% observed in Zambian men in an HIV-discordant relationship, Ugandan men from Lake Victoria fishing communities, men who have sex with men, and several cohorts of women. HIV incidence tended to fall after the first three months in the study and over calendar time. Among suspected transmission pairs, 28% of HIV infections were not from the reported partner. Volunteers with high incidence were successfully identified and enrolled into large scale cohort studies. Over a quarter of new cases in couples acquired infection from persons other than the suspected transmitting partner.

  3. Creating an African HIV Clinical Research and Prevention Trials Network: HIV Prevalence, Incidence and Transmission

    Science.gov (United States)

    Kamali, Anatoli; Price, Matt A.; Lakhi, Shabir; Karita, Etienne; Inambao, Mubiana; Sanders, Eduard J.; Anzala, Omu; Latka, Mary H.; Bekker, Linda-Gail; Kaleebu, Pontiano; Asiki, Gershim; Ssetaala, Ali; Ruzagira, Eugene; Allen, Susan; Farmer, Paul; Hunter, Eric; Mutua, Gaudensia; Makkan, Heeran; Tichacek, Amanda; Brill, Ilene K.; Fast, Pat; Stevens, Gwynn; Chetty, Paramesh; Amornkul, Pauli N.; Gilmour, Jill

    2015-01-01

    HIV epidemiology informs prevention trial design and program planning. Nine clinical research centers (CRC) in sub-Saharan Africa conducted HIV observational epidemiology studies in populations at risk for HIV infection as part of an HIV prevention and vaccine trial network. Annual HIV incidence ranged from below 2% to above 10% and varied by CRC and risk group, with rates above 5% observed in Zambian men in an HIV-discordant relationship, Ugandan men from Lake Victoria fishing communities, men who have sex with men, and several cohorts of women. HIV incidence tended to fall after the first three months in the study and over calendar time. Among suspected transmission pairs, 28% of HIV infections were not from the reported partner. Volunteers with high incidence were successfully identified and enrolled into large scale cohort studies. Over a quarter of new cases in couples acquired infection from persons other than the suspected transmitting partner. PMID:25602351

  4. A randomized controlled trial of a smoking cessation self-help intervention for dual users of tobacco cigarettes and E-cigarettes: Intervention development and research design.

    Science.gov (United States)

    Meltzer, Lauren R; Simmons, Vani N; Sutton, Steven K; Drobes, David J; Quinn, Gwendolyn P; Meade, Cathy D; Unrod, Marina; Brandon, Karen O; Harrell, Paul T; Eissenberg, Thomas; Bullen, Christopher R; Brandon, Thomas H

    2017-09-01

    Electronic Nicotine Delivery Systems, also called electronic cigarettes or e-cigarettes, have been available for over a decade and use has been increasing dramatically. The primary reported reasons for use are to aid smoking cessation or reduction, yet a significant proportion appear to be long-term users of both products ("dual users"). Dual users may be motivated to quit smoking and might benefit from a behavioral intervention for smoking cessation. This paper describes the intervention development, as well as the design, methods, and data analysis plans for an ongoing randomized controlled trial (RCT). Formative research and learner verification were conducted to create a usable, understandable, and acceptable self-help intervention targeting dual users. The efficacy is being tested in an RCT with current dual users (N=2900) recruited nationally and randomized to one of three conditions. The Assessment Only (ASSESS) group only completes assessments. The Generic Self-Help (GENERIC) group receives non-targeted smoking cessation booklets and supplemental materials sent monthly over 18months. The e-cigarette Targeted Self-Help (eTARGET) group receives the newly developed intervention (targeted booklets and supplemental materials) sent over the same period. All participants complete self-report surveys every 3months over 2years. The primary study outcome is self-reported 7-day point prevalence abstinence. Cost-effectiveness metrics for the GENERIC and eTARGET interventions will also be calculated. Copyright © 2017 Elsevier Inc. All rights reserved.

  5. Clinical Trials

    Medline Plus

    Full Text Available ... protocol affect the trial's results. Comparison Groups In most clinical trials, researchers use comparison groups. This means ... study before you agree to take part. Randomization Most clinical trials that have comparison groups use randomization. ...

  6. Clinical Trials

    Medline Plus

    Full Text Available ... Trials About Clinical Trials Clinical trials are research studies that explore whether a medical strategy, treatment, or ... and Clinical Studies Web page. Children and Clinical Studies Learn more about Children and Clinical Studies Importance ...

  7. Efficacy of Mobile Serious Games in Increasing HIV Risk Perception in Swaziland: A Randomized Control Trial (SGprev Trial) Research Protocol

    Science.gov (United States)

    Musumari, Patou; El-Saaidi, Christina; Techasrivichien, Teeranee; Suguimoto, S. Pilar; Ono Kihara, Masako; Kihara, Masahiro

    2016-01-01

    the mean change in the wait-list control group at 4-weeks post-intervention. We will use standardized regression coefficients to calculate the effect of the intervention on our primary outcome with P values. We will conduct both intention to treat and as treated analysis. Results This study is funded by Hayao Nakayama Foundation for Science & Technology and Culture; Grant number H26-A2-41. The research and development approval has been obtained from Kyoto University Graduate School and Faculty of Medicine Ethics Committee, Japan, and Swaziland’s Ministry of Health Ethics and Scientific committee. Results are expected in February 2017. Conclusions This study will provide evidence on the efficiency of a mobile phone interactive game in increasing HIV risk perception in Swaziland. Our findings may also be generalizable to similar settings in SSA. Trial Registration University Hospital Medical Information Network Clinical Trial Registry ID number (UMIN-CTR):UMIN000021781; URL:https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025103 (Archived by WebCite at http://www.webcitation.org/6hOphB11a). PMID:27876685

  8. Research staff training in a multisite randomized clinical trial: Methods and recommendations from the Stimulant Reduction Intervention using Dosed Exercise (STRIDE) trial.

    Science.gov (United States)

    Walker, Robrina; Morris, David W; Greer, Tracy L; Trivedi, Madhukar H

    2014-01-01

    Descriptions of and recommendations for meeting the challenges of training research staff for multisite studies are limited despite the recognized importance of training on trial outcomes. The STRIDE (STimulant Reduction Intervention using Dosed Exercise) study is a multisite randomized clinical trial that was conducted at nine addiction treatment programs across the United States within the National Drug Abuse Treatment Clinical Trials Network (CTN) and evaluated the addition of exercise to addiction treatment as usual (TAU), compared to health education added to TAU, for individuals with stimulant abuse or dependence. Research staff administered a variety of measures that required a range of interviewing, technical, and clinical skills. In order to address the absence of information on how research staff are trained for multisite clinical studies, the current manuscript describes the conceptual process of training and certifying research assistants for STRIDE. Training was conducted using a three-stage process to allow staff sufficient time for distributive learning, practice, and calibration leading up to implementation of this complex study. Training was successfully implemented with staff across nine sites. Staff demonstrated evidence of study and procedural knowledge via quizzes and skill demonstration on six measures requiring certification. Overall, while the majority of staff had little to no experience in the six measures, all research assistants demonstrated ability to correctly and reliably administer the measures throughout the study. Practical recommendations are provided for training research staff and are particularly applicable to the challenges encountered with large, multisite trials.

  9. Citation of prior research has increased in introduction and discussion sections with time: A survey of clinical trials in physiotherapy.

    Science.gov (United States)

    Hoderlein, Xenia; Moseley, Anne M; Elkins, Mark R

    2017-08-01

    Many clinical trials are reported without reference to the existing relevant high-quality research. This study aimed to investigate the extent to which authors of reports of clinical trials of physiotherapy interventions try to use high-quality clinical research to (1) help justify the need for the trial in the introduction and (2) help interpret the trial's results in the discussion. Data were extracted from 221 clinical trials that were randomly selected from the Physiotherapy Evidence Database: 70 published in 2001 (10% sample) and 151 published in 2015 (10% sample). The Physiotherapy Evidence Database score (which rates methodological quality and completeness of reporting) for each trial was also downloaded. Overall 41% of trial reports cited a systematic review or the results of a search for other evidence in the introduction section: 20% for 2001 and 50% for 2015 (relative risk = 2.3, 95% confidence interval = 1.5-3.8). For the discussion section, only 1 of 221 trials integrated the results of the trial into an existing meta-analysis, but citation of a relevant systematic review did increase from 17% in 2001 to 34% in 2015. There was no relationship between citation of existing research and the total Physiotherapy Evidence Database score. Published reports of clinical trials of physiotherapy interventions increasingly cite a systematic review or the results of a search for other evidence in the introduction, but integration with existing research in the discussion section is very rare. To encourage the use of existing research, stronger recommendations to refer to existing systematic reviews (where available) could be incorporated into reporting checklists and journal editorial guidelines.

  10. Trial Promoter: A Web-Based Tool for Boosting the Promotion of Clinical Research Through Social Media.

    Science.gov (United States)

    Reuter, Katja; Ukpolo, Francis; Ward, Edward; Wilson, Melissa L; Angyan, Praveen

    2016-06-29

    Scarce information about clinical research, in particular clinical trials, is among the top reasons why potential participants do not take part in clinical studies. Without volunteers, on the other hand, clinical research and the development of novel approaches to preventing, diagnosing, and treating disease are impossible. Promising digital options such as social media have the potential to work alongside traditional methods to boost the promotion of clinical research. However, investigators and research institutions are challenged to leverage these innovations while saving time and resources. To develop and test the efficiency of a Web-based tool that automates the generation and distribution of user-friendly social media messages about clinical trials. Trial Promoter is developed in Ruby on Rails, HTML, cascading style sheet (CSS), and JavaScript. In order to test the tool and the correctness of the generated messages, clinical trials (n=46) were randomized into social media messages and distributed via the microblogging social media platform Twitter and the social network Facebook. The percent correct was calculated to determine the probability with which Trial Promoter generates accurate messages. During a 10-week testing phase, Trial Promoter automatically generated and published 525 user-friendly social media messages on Twitter and Facebook. On average, Trial Promoter correctly used the message templates and substituted the message parameters (text, URLs, and disease hashtags) 97.7% of the time (1563/1600). Trial Promoter may serve as a promising tool to render clinical trial promotion more efficient while requiring limited resources. It supports the distribution of any research or other types of content. The Trial Promoter code and installation instructions are freely available online.

  11. Embedded software verification and debugging

    CERN Document Server

    Winterholer, Markus

    2017-01-01

    This book provides comprehensive coverage of verification and debugging techniques for embedded software, which is frequently used in safety critical applications (e.g., automotive), where failures are unacceptable. Since the verification of complex systems needs to encompass the verification of both hardware and embedded software modules, this book focuses on verification and debugging approaches for embedded software with hardware dependencies. Coverage includes the entire flow of design, verification and debugging of embedded software and all key approaches to debugging, dynamic, static, and hybrid verification. This book discusses the current, industrial embedded software verification flow, as well as emerging trends with focus on formal and hybrid verification and debugging approaches. Includes in a single source the entire flow of design, verification and debugging of embedded software; Addresses the main techniques that are currently being used in the industry for assuring the quality of embedded softw...

  12. A conceptual model for the development process of confirmatory adaptive clinical trials within an emergency research network.

    Science.gov (United States)

    Mawocha, Samkeliso C; Fetters, Michael D; Legocki, Laurie J; Guetterman, Timothy C; Frederiksen, Shirley; Barsan, William G; Lewis, Roger J; Berry, Donald A; Meurer, William J

    2017-06-01

    Adaptive clinical trials use accumulating data from enrolled subjects to alter trial conduct in pre-specified ways based on quantitative decision rules. In this research, we sought to characterize the perspectives of key stakeholders during the development process of confirmatory-phase adaptive clinical trials within an emergency clinical trials network and to build a model to guide future development of adaptive clinical trials. We used an ethnographic, qualitative approach to evaluate key stakeholders' views about the adaptive clinical trial development process. Stakeholders participated in a series of multidisciplinary meetings during the development of five adaptive clinical trials and completed a Strengths-Weaknesses-Opportunities-Threats questionnaire. In the analysis, we elucidated overarching themes across the stakeholders' responses to develop a conceptual model. Four major overarching themes emerged during the analysis of stakeholders' responses to questioning: the perceived statistical complexity of adaptive clinical trials and the roles of collaboration, communication, and time during the development process. Frequent and open communication and collaboration were viewed by stakeholders as critical during the development process, as were the careful management of time and logistical issues related to the complexity of planning adaptive clinical trials. The Adaptive Design Development Model illustrates how statistical complexity, time, communication, and collaboration are moderating factors in the adaptive design development process. The intensity and iterative nature of this process underscores the need for funding mechanisms for the development of novel trial proposals in academic settings.

  13. A booklet on participants' rights to improve consent for clinical research: a randomized trial.

    Directory of Open Access Journals (Sweden)

    Jocelyne R Benatar

    Full Text Available OBJECTIVE: Information on the rights of subjects in clinical trials has become increasingly complex and difficult to understand. This study evaluates whether a simple booklet which is relevant to all research studies improves the understanding of rights needed for subjects to provide informed consent. METHODS: 21 currently used informed consent forms (ICF from international clinical trials were separated into information related to the specific research study, and general information on participants' rights. A booklet designed to provide information on participants' rights which used simple language was developed to replace this information in current ICF's Readability of each component of ICF's and the booklet was then assessed using the Flesch-Kincaid Reading ease score (FK. To further evaluate the booklet 282 hospital inpatients were randomised to one of three ways to present research information; a standard ICF, the booklet combined with a short ICF, or the booklet combined with a simplified ICF. Comprehension of information related to the research proposal and to participant's rights was assessed by questionnaire. RESULTS: Information related to participants' rights contributed an average of 44% of the words in standard ICFs, and was harder to read than information describing the clinical trial (FK 25 versus (vs. 41 respectively, p = 0.0003. The booklet reduced the number of words and improved FK from 25 to 42. The simplified ICF had a slightly higher FK score than the standard ICF (50 vs. 42. Comprehension assessed in inpatients was better for the booklet and short ICF 62%, (95% confidence interval (CI 56 to 67 correct, or simplified ICF 62% (CI 58 to 68 correct compared to 52%, (CI 47 to 57 correct for the standard ICF, p = 0.009. This was due to better understanding of questions on rights (62% vs. 49% correct, p = 0.0008. Comprehension of study related information was similar for the simplified and standard ICF (60% vs. 64

  14. A booklet on participants' rights to improve consent for clinical research: a randomized trial.

    Science.gov (United States)

    Benatar, Jocelyne R; Mortimer, John; Stretton, Matthew; Stewart, Ralph A H

    2012-01-01

    Information on the rights of subjects in clinical trials has become increasingly complex and difficult to understand. This study evaluates whether a simple booklet which is relevant to all research studies improves the understanding of rights needed for subjects to provide informed consent. 21 currently used informed consent forms (ICF) from international clinical trials were separated into information related to the specific research study, and general information on participants' rights. A booklet designed to provide information on participants' rights which used simple language was developed to replace this information in current ICF's Readability of each component of ICF's and the booklet was then assessed using the Flesch-Kincaid Reading ease score (FK). To further evaluate the booklet 282 hospital inpatients were randomised to one of three ways to present research information; a standard ICF, the booklet combined with a short ICF, or the booklet combined with a simplified ICF. Comprehension of information related to the research proposal and to participant's rights was assessed by questionnaire. Information related to participants' rights contributed an average of 44% of the words in standard ICFs, and was harder to read than information describing the clinical trial (FK 25 versus (vs.) 41 respectively, p = 0.0003). The booklet reduced the number of words and improved FK from 25 to 42. The simplified ICF had a slightly higher FK score than the standard ICF (50 vs. 42). Comprehension assessed in inpatients was better for the booklet and short ICF 62%, (95% confidence interval (CI) 56 to 67) correct, or simplified ICF 62% (CI 58 to 68) correct compared to 52%, (CI 47 to 57) correct for the standard ICF, p = 0.009. This was due to better understanding of questions on rights (62% vs. 49% correct, p = 0.0008). Comprehension of study related information was similar for the simplified and standard ICF (60% vs. 64% correct, p = 0.68). A booklet

  15. New phase II trial of avelumab, a PD-L1 inhibitor, in recurrent respiratory papillomatosis | Center for Cancer Research

    Science.gov (United States)

    Dr. Christian Hinrichs, Investigator and Lasker Clinical Research Scholar in the Experimental Transplantation and Immunology Branch (ETIB), is leading a trial of avelumab in patients with recurrent respiratory papillomatosis (RRP). Learn more...

  16. Evaluating research and impact: a bibliometric analysis of research by the NIH/NIAID HIV/AIDS clinical trials networks.

    Directory of Open Access Journals (Sweden)

    Scott R Rosas

    2011-03-01

    Full Text Available Evaluative bibliometrics uses advanced techniques to assess the impact of scholarly work in the context of other scientific work and usually compares the relative scientific contributions of research groups or institutions. Using publications from the National Institute of Allergy and Infectious Diseases (NIAID HIV/AIDS extramural clinical trials networks, we assessed the presence, performance, and impact of papers published in 2006-2008. Through this approach, we sought to expand traditional bibliometric analyses beyond citation counts to include normative comparisons across journals and fields, visualization of co-authorship across the networks, and assess the inclusion of publications in reviews and syntheses. Specifically, we examined the research output of the networks in terms of the a presence of papers in the scientific journal hierarchy ranked on the basis of journal influence measures, b performance of publications on traditional bibliometric measures, and c impact of publications in comparisons with similar publications worldwide, adjusted for journals and fields. We also examined collaboration and interdisciplinarity across the initiative, through network analysis and modeling of co-authorship patterns. Finally, we explored the uptake of network produced publications in research reviews and syntheses. Overall, the results suggest the networks are producing highly recognized work, engaging in extensive interdisciplinary collaborations, and having an impact across several areas of HIV-related science. The strengths and limitations of the approach for evaluation and monitoring research initiatives are discussed.

  17. Doctors and Vampires in Sub-Saharan Africa: Ethical Challenges in Clinical Trial Research

    Science.gov (United States)

    Peeters Grietens, Koen; Ribera, Joan Muela; Erhart, Annette; Hoibak, Sarah; Ravinetto, Raffaella M.; Gryseels, Charlotte; Dierickx, Susan; O'Neill, Sarah; Muela, Susanna Hausmann; D'Alessandro, Umberto

    2014-01-01

    Collecting blood samples from individuals recruited into clinical research projects in sub-Saharan Africa can be challenging. Strikingly, one of the reasons for participant reticence is the occurrence of local rumors surrounding “blood stealing” or “blood selling.” Such fears can potentially have dire effects on the success of research projects—for example, high dropout rates that would invalidate the trial's results—and have ethical implications related to cultural sensitivity and informed consent. Though commonly considered as a manifestation of the local population's ignorance, these rumors represent a social diagnosis and a logical attempt to make sense of sickness and health. Born from historical antecedents, they reflect implicit contemporary structural inequalities and the social distance between communities and public health institutions. We aim at illustrating the underlying logic governing patients' fear and argue that the management of these beliefs should become an intrinsic component of clinical research. PMID:24821846

  18. [The advance in the research and therapeutic trials of amyotrophic lateral sclerosis].

    Science.gov (United States)

    Moriwaka, F; Tashiro, K

    2000-12-01

    The research concerning with the pathogenesis of amyotrophic lateral sclerosis (ALS) has been in steady progress in the last 10 years, including discovery of SOD mutation in familial ALS. Riluzole, by its inhibiting excitatory amino acid release, is the only drug, which has been demonstrated the neuroprotective activity in the randomised double-blind placebo-controlled clinical trials in patients with ALS, although many other clinical therapeutic trials for ALS patients has been carried out. We discussed the clinical trials being the under way, especially SR57746A, (1-[2-(naphth-2-yl)ethy]-4-(3-trifluoromethyl phenyl)-1, 2, 5, 6-tetrahydro-pyridine, hydrochloride), a non-peptide compound which has been shown to exhibit a wide range of neurotrophic effects both in vitro and in vivo, and its phase II study in Japan and two kinds of phase III studies ongoing in the United States, Canada and Europe. We also introduced the clinical guideline for practice and care of ALS patients proposed by American Academy of Neurology, expecting to establish clinical guideline to be applicable to Japanese cases.

  19. Efficacy of Mobile Serious Games in Increasing HIV Risk Perception in Swaziland: A Randomized Control Trial (SGprev Trial) Research Protocol.

    Science.gov (United States)

    Lukhele, Bhekumusa Wellington; Musumari, Patou; El-Saaidi, Christina; Techasrivichien, Teeranee; Suguimoto, S Pilar; Ono Kihara, Masako; Kihara, Masahiro

    2016-11-22

    -list control group at 4-weeks post-intervention. We will use standardized regression coefficients to calculate the effect of the intervention on our primary outcome with P values. We will conduct both intention to treat and as treated analysis. This study is funded by Hayao Nakayama Foundation for Science & Technology and Culture; Grant number H26-A2-41. The research and development approval has been obtained from Kyoto University Graduate School and Faculty of Medicine Ethics Committee, Japan, and Swaziland's Ministry of Health Ethics and Scientific committee. Results are expected in February 2017. This study will provide evidence on the efficiency of a mobile phone interactive game in increasing HIV risk perception in Swaziland. Our findings may also be generalizable to similar settings in SSA. University Hospital Medical Information Network Clinical Trial Registry ID number (UMIN-CTR):UMIN000021781; URL:https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025103 (Archived by WebCite at http://www.webcitation.org/6hOphB11a). ©Bhekumusa Wellington Lukhele, Patou Musumari, Christina El-Saaidi, Teeranee Techasrivichien, S. Pilar Suguimoto, Masako Ono Kihara, Masahiro Kihara. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 22.11.2016.

  20. Implementation of clinical research trials using web-based and mobile devices: challenges and solutions

    Directory of Open Access Journals (Sweden)

    Roy Eagleson

    2017-03-01

    Full Text Available Abstract Background With the increasing implementation of web-based, mobile health interventions in clinical trials, it is crucial for researchers to address the security and privacy concerns of patient information according to high ethical standards. The full process of meeting these standards is often made more complicated due to the use of internet-based technology and smartphones for treatment, telecommunication, and data collection; however, this process is not well-documented in the literature. Results The Smart Heart Trial is a single-arm feasibility study that is currently assessing the effects of a web-based, mobile lifestyle intervention for overweight and obese children and youth with congenital heart disease in Southwestern Ontario. Participants receive telephone counseling regarding nutrition and fitness; and complete goal-setting activities on a web-based application. This paper provides a detailed overview of the challenges the study faced in meeting the high standards of our Research Ethics Board, specifically regarding patient privacy. Conclusion We outline our solutions, successes, limitations, and lessons learned to inform future similar studies; and model much needed transparency in ensuring high quality security and protection of patient privacy when using web-based and mobile devices for telecommunication and data collection in clinical research.

  1. When referring physicians and researchers disagree on equipoise: the TOTAL trial experience.

    Science.gov (United States)

    Rodrigues, H C M L; Deprest, J; v d Berg, P P

    2011-06-01

    In this article, we reflect on whether randomized controlled trials (RCTs) are adequate for the clinical evaluation of maternal-fetal surgery for congenital diaphragmatic hernia (CDH), focusing on the role of patients' preferences in the setting up of research protocols, on the requirement of equipoise and on the concept of therapeutic misconception (TM). We describe the conception and setting up of the tracheal occlusion (TO) to accelerate lung growth trial and analyze the ethical dilemmas faced by the research team during that time. Depending on the view adopted regarding the scope of equipoise, there are two ways of dealing with patient's preferences concerning fetoscopic endoluminal TO and expectant management during pregnancy for CDH. The solution adopted for fetoscopic endoluminal tracheal occlusion (FETO) is justified by the extended period of time it has been available to patients before the start of the RCT. Strong patient and referring physician preferences do not entail a right to have FETO, since it is a procedure of yet unproven efficacy and safety. In the future, to avoid the dilemmas posed by the TM and in name of the right of future generations of patients to have access to treatment of proven safety and efficacy, researchers must be able to plan RCT in due time. Copyright © 2011 John Wiley & Sons, Ltd.

  2. Verification and nuclear material security

    International Nuclear Information System (INIS)

    ElBaradei, M.

    2001-01-01

    Full text: The Director General will open the symposium by presenting a series of challenges facing the international safeguards community: the need to ensure a robust system, with strong verification tools and a sound research and development programme; the importance of securing the necessary support for the system, in terms of resources; the effort to achieve universal participation in the non-proliferation regime; and the necessity of re-energizing disarmament efforts. Special focus will be given to the challenge underscored by recent events, of strengthening international efforts to combat nuclear terrorism. (author)

  3. Readability of informed consent forms in clinical trials conducted in a skin research center

    Science.gov (United States)

    Samadi, Aniseh; Asghari, Fariba

    2016-01-01

    Obtaining informed consents is one of the most fundamental principles in conducting a clinical trial. In order for the consent to be informed, the patient must receive and comprehend the information appropriately. Complexity of the consent form is a common problem that has been shown to be a major barrier to comprehension for many patients. The objective of this study was to assess the readability of different templates of informed consent forms (ICFs) used in clinical trials in the Center for Research and Training in Skin Diseases and Leprosy (CRTSDL), Tehran, Iran. This study was conducted on ICFs of 45 clinical trials of the CRTSDL affiliated with Tehran University of Medical Sciences. ICFs were tested for reading difficulty, using the readability assessments formula adjusted for the Persian language including the Flesch–Kincaid reading ease score, Flesch–Kincaid grade level, and Gunning fog index. Mean readability score of the whole text of ICFs as well as their 7 main information parts were calculated. The mean ± SD Flesch Reading Ease score for all ICFs was 31.96 ± 5.62 that is in the difficult range. The mean ± SD grade level was calculated as 10.71 ± 1.8 (8.23–14.09) using the Flesch–Kincaid formula and 14.64 ± 1.22 (12.67–18.27) using the Gunning fog index. These results indicate that the text is expected to be understandable for an average student in the 11th grade, while the ethics committee recommend grade level 8 as the standard readability level for ICFs. The results showed that the readability scores of ICFs assessed in our study were not in the acceptable range. This means they were too complex to be understood by the general population. Ethics committees must examine the simplicity and readability of ICFs used in clinical trials. PMID:27471590

  4. Training Needs of Clinical and Research Professionals to Optimize Minority Recruitment and Retention in Cancer Clinical Trials.

    Science.gov (United States)

    Niranjan, Soumya J; Durant, Raegan W; Wenzel, Jennifer A; Cook, Elise D; Fouad, Mona N; Vickers, Selwyn M; Konety, Badrinath R; Rutland, Sarah B; Simoni, Zachary R; Martin, Michelle Y

    2017-08-03

    The study of disparities in minority recruitment to cancer clinical trials has focused primarily on inquiries among minority patient populations. However, clinical trial recruitment is complex and requires a broader appreciation of the multiple factors that influence minority participation. One area that has received little attention is minority recruitment training for professionals who assume various roles in the clinical trial recruitment process. Therefore, we assessed the perspectives of cancer center clinical and research personnel on their training and education needs toward minority recruitment for cancer clinical trials. Ninety-one qualitative interviews were conducted at five U.S. cancer centers among four stakeholder groups: cancer center leaders, principal investigators, referring clinicians, and research staff. Interviews were recorded and transcribed. Qualitative analyses focused on response data related to training for minority recruitment for cancer clinical trials. Four prominent themes were identified: (1) Research personnel are not currently being trained to focus on recruitment and retention of minority populations; (2) Training for minority recruitment and retention provides for a specific focus on factors influencing minority research participation; (3) Training on cultural awareness may help to bridge cultural gaps between potential minority participants and research professionals; (4) Views differ regarding the importance of research personnel training designed to focus on recruitment of minority populations. There is a lack of systematic training for minority recruitment. Many stakeholders acknowledged the benefits of minority recruitment training and welcomed training that focuses on increasing cultural awareness to increase the participation of minorities in cancer clinical trials.

  5. Engaging Nurses in Research for a Randomized Clinical Trial of a Behavioral Health Intervention

    Directory of Open Access Journals (Sweden)

    Lona Roll

    2013-01-01

    Full Text Available Nurse involvement in research is essential to the expansion of nursing science and improved care for patients. The research participation challenges encountered by nurses providing direct care (direct care nurses include balancing patient care demands with research, adjusting to fluctuating staff and patient volumes, working with interdisciplinary personnel, and feeling comfortable with their knowledge of the research process. The purpose of this paper is to describe efforts to engage nurses in research for the Stories and Music for Adolescent/Young Adult Resilience during Transplant (SMART study. SMART was an NIH-funded, multisite, randomized, behavioral clinical trial of a music therapy intervention for adolescents/young adults (AYA undergoing stem cell transplant for an oncology condition. The study was conducted at 8 sites by a large multidisciplinary team that included direct care nurses, advanced practice nurses, and nurse researchers, as well as board-certified music therapists, clinical research coordinators, and physicians. Efforts to include direct care nurses in the conduct of this study fostered mutual respect across disciplines in both academic and clinical settings.

  6. Procedure generation and verification

    International Nuclear Information System (INIS)

    Sheely, W.F.

    1986-01-01

    The Department of Energy has used Artificial Intelligence of ''AI'' concepts to develop two powerful new computer-based techniques to enhance safety in nuclear applications. The Procedure Generation System, and the Procedure Verification System, can be adapted to other commercial applications, such as a manufacturing plant. The Procedure Generation System can create a procedure to deal with the off-normal condition. The operator can then take correct actions on the system in minimal time. The Verification System evaluates the logic of the Procedure Generator's conclusions. This evaluation uses logic techniques totally independent of the Procedure Generator. The rapid, accurate generation and verification of corrective procedures can greatly reduce the human error, possible in a complex (stressful/high stress) situation

  7. Nuclear disarmament verification

    International Nuclear Information System (INIS)

    DeVolpi, A.

    1993-01-01

    Arms control treaties, unilateral actions, and cooperative activities -- reflecting the defusing of East-West tensions -- are causing nuclear weapons to be disarmed and dismantled worldwide. In order to provide for future reductions and to build confidence in the permanency of this disarmament, verification procedures and technologies would play an important role. This paper outlines arms-control objectives, treaty organization, and actions that could be undertaken. For the purposes of this Workshop on Verification, nuclear disarmament has been divided into five topical subareas: Converting nuclear-weapons production complexes, Eliminating and monitoring nuclear-weapons delivery systems, Disabling and destroying nuclear warheads, Demilitarizing or non-military utilization of special nuclear materials, and Inhibiting nuclear arms in non-nuclear-weapons states. This paper concludes with an overview of potential methods for verification

  8. Trials

    Directory of Open Access Journals (Sweden)

    Michele Fornaro

    2010-01-01

    Full Text Available Mental Retardation (MR is a developmental disability characterized by impairments in adaptive daily life skills and difficulties in social and interpersonal functioning. Since multiple causes may contribute to MR, associated clinical pictures may vary accordingly. Nevertheless, when psychiatric disorders as Treatment Resistant Depression (TRD and/or alcohol abuse co-exist, their proper detection and management is often troublesome, essentially due to a limited vocabulary MR people could use to describe their symptoms, feelings and concerns, and the lack of reliable screening tools. Furthermore, MR people are among the most medicated subjects, with (over prescription of antidepressants and/or typical antipsychotics being the rule rather than exception. Thus, treatment resistance or even worsening of depression, constitute frequent occurrences. This report describes the case of a person with MR who failed to respond to repetitive trials of antidepressant monotherapies, finally recovering using aripiprazole to fluvoxamine augmentation upon consideration of a putative bipolar diathesis for “agitated” TRD. Although further controlled investigations are needed to assess a putative bipolar diathesis in some cases of MR associated to TRD, prudence is advised in the long-term prescription of antidepressant monotherapies in such conditions.

  9. Comparison of lumiracoxib with naproxen and ibuprofen in the Therapeutic Arthritis Research and Gastrointestinal Event Trial (TARGET), cardiovascular outcomes: randomised controlled trial.

    NARCIS (Netherlands)

    Farkouh, M.E.; Kirshner, H.; Harrington, R.A.; Ruland, S.; Verheugt, F.W.A.; Schnitzer, T.J.; Burmester, G.R.; Mysler, E.; Hochberg, M.C.; Doherty, M.; Ehrsam, E.; Gitton, X.; Krammer, G.; Mellein, B.; Gimona, A.; Matchaba, P.; Hawkey, C.J.; Chesebro, J.H.

    2004-01-01

    BACKGROUND: The potential for cyclo-oxygenase 2 (COX2)-selective inhibitors to increase the risk for myocardial infarction is controversial. The Therapeutic Arthritis Research and Gastrointestinal Event Trial (TARGET) aimed to assess gastrointestinal and cardiovascular safety of the COX2 inhibitor

  10. Verification of Ceramic Structures

    Science.gov (United States)

    Behar-Lafenetre, Stephanie; Cornillon, Laurence; Rancurel, Michael; De Graaf, Dennis; Hartmann, Peter; Coe, Graham; Laine, Benoit

    2012-07-01

    In the framework of the “Mechanical Design and Verification Methodologies for Ceramic Structures” contract [1] awarded by ESA, Thales Alenia Space has investigated literature and practices in affiliated industries to propose a methodological guideline for verification of ceramic spacecraft and instrument structures. It has been written in order to be applicable to most types of ceramic or glass-ceramic materials - typically Cesic®, HBCesic®, Silicon Nitride, Silicon Carbide and ZERODUR®. The proposed guideline describes the activities to be performed at material level in order to cover all the specific aspects of ceramics (Weibull distribution, brittle behaviour, sub-critical crack growth). Elementary tests and their post-processing methods are described, and recommendations for optimization of the test plan are given in order to have a consistent database. The application of this method is shown on an example in a dedicated article [7]. Then the verification activities to be performed at system level are described. This includes classical verification activities based on relevant standard (ECSS Verification [4]), plus specific analytical, testing and inspection features. The analysis methodology takes into account the specific behaviour of ceramic materials, especially the statistical distribution of failures (Weibull) and the method to transfer it from elementary data to a full-scale structure. The demonstration of the efficiency of this method is described in a dedicated article [8]. The verification is completed by classical full-scale testing activities. Indications about proof testing, case of use and implementation are given and specific inspection and protection measures are described. These additional activities are necessary to ensure the required reliability. The aim of the guideline is to describe how to reach the same reliability level as for structures made of more classical materials (metals, composites).

  11. Verification and validation benchmarks.

    Energy Technology Data Exchange (ETDEWEB)

    Oberkampf, William Louis; Trucano, Timothy Guy

    2007-02-01

    Verification and validation (V&V) are the primary means to assess the accuracy and reliability of computational simulations. V&V methods and procedures have fundamentally improved the credibility of simulations in several high-consequence fields, such as nuclear reactor safety, underground nuclear waste storage, and nuclear weapon safety. Although the terminology is not uniform across engineering disciplines, code verification deals with assessing the reliability of the software coding, and solution verification deals with assessing the numerical accuracy of the solution to a computational model. Validation addresses the physics modeling accuracy of a computational simulation by comparing the computational results with experimental data. Code verification benchmarks and validation benchmarks have been constructed for a number of years in every field of computational simulation. However, no comprehensive guidelines have been proposed for the construction and use of V&V benchmarks. For example, the field of nuclear reactor safety has not focused on code verification benchmarks, but it has placed great emphasis on developing validation benchmarks. Many of these validation benchmarks are closely related to the operations of actual reactors at near-safety-critical conditions, as opposed to being more fundamental-physics benchmarks. This paper presents recommendations for the effective design and use of code verification benchmarks based on manufactured solutions, classical analytical solutions, and highly accurate numerical solutions. In addition, this paper presents recommendations for the design and use of validation benchmarks, highlighting the careful design of building-block experiments, the estimation of experimental measurement uncertainty for both inputs and outputs to the code, validation metrics, and the role of model calibration in validation. It is argued that the understanding of predictive capability of a computational model is built on the level of

  12. Verification and validation benchmarks

    International Nuclear Information System (INIS)

    Oberkampf, William Louis; Trucano, Timothy Guy

    2007-01-01

    Verification and validation (V and V) are the primary means to assess the accuracy and reliability of computational simulations. V and V methods and procedures have fundamentally improved the credibility of simulations in several high-consequence fields, such as nuclear reactor safety, underground nuclear waste storage, and nuclear weapon safety. Although the terminology is not uniform across engineering disciplines, code verification deals with assessing the reliability of the software coding, and solution verification deals with assessing the numerical accuracy of the solution to a computational model. Validation addresses the physics modeling accuracy of a computational simulation by comparing the computational results with experimental data. Code verification benchmarks and validation benchmarks have been constructed for a number of years in every field of computational simulation. However, no comprehensive guidelines have been proposed for the construction and use of V and V benchmarks. For example, the field of nuclear reactor safety has not focused on code verification benchmarks, but it has placed great emphasis on developing validation benchmarks. Many of these validation benchmarks are closely related to the operations of actual reactors at near-safety-critical conditions, as opposed to being more fundamental-physics benchmarks. This paper presents recommendations for the effective design and use of code verification benchmarks based on manufactured solutions, classical analytical solutions, and highly accurate numerical solutions. In addition, this paper presents recommendations for the design and use of validation benchmarks, highlighting the careful design of building-block experiments, the estimation of experimental measurement uncertainty for both inputs and outputs to the code, validation metrics, and the role of model calibration in validation. It is argued that the understanding of predictive capability of a computational model is built on the

  13. Verification and validation benchmarks

    International Nuclear Information System (INIS)

    Oberkampf, William L.; Trucano, Timothy G.

    2008-01-01

    Verification and validation (V and V) are the primary means to assess the accuracy and reliability of computational simulations. V and V methods and procedures have fundamentally improved the credibility of simulations in several high-consequence fields, such as nuclear reactor safety, underground nuclear waste storage, and nuclear weapon safety. Although the terminology is not uniform across engineering disciplines, code verification deals with assessing the reliability of the software coding, and solution verification deals with assessing the numerical accuracy of the solution to a computational model. Validation addresses the physics modeling accuracy of a computational simulation by comparing the computational results with experimental data. Code verification benchmarks and validation benchmarks have been constructed for a number of years in every field of computational simulation. However, no comprehensive guidelines have been proposed for the construction and use of V and V benchmarks. For example, the field of nuclear reactor safety has not focused on code verification benchmarks, but it has placed great emphasis on developing validation benchmarks. Many of these validation benchmarks are closely related to the operations of actual reactors at near-safety-critical conditions, as opposed to being more fundamental-physics benchmarks. This paper presents recommendations for the effective design and use of code verification benchmarks based on manufactured solutions, classical analytical solutions, and highly accurate numerical solutions. In addition, this paper presents recommendations for the design and use of validation benchmarks, highlighting the careful design of building-block experiments, the estimation of experimental measurement uncertainty for both inputs and outputs to the code, validation metrics, and the role of model calibration in validation. It is argued that the understanding of predictive capability of a computational model is built on the

  14. What qualitative research can contribute to a randomized controlled trial of a complex community intervention.

    Science.gov (United States)

    Nelson, Geoffrey; Macnaughton, Eric; Goering, Paula

    2015-11-01

    Using the case of a large-scale, multi-site Canadian Housing First research demonstration project for homeless people with mental illness, At Home/Chez Soi, we illustrate the value of qualitative methods in a randomized controlled trial (RCT) of a complex community intervention. We argue that quantitative RCT research can neither capture the complexity nor tell the full story of a complex community intervention. We conceptualize complex community interventions as having multiple phases and dimensions that require both RCT and qualitative research components. Rather than assume that qualitative research and RCTs are incommensurate, a more pragmatic mixed methods approach was used, which included using both qualitative and quantitative methods to understand program implementation and outcomes. At the same time, qualitative research was used to examine aspects of the intervention that could not be understood through the RCT, such as its conception, planning, sustainability, and policy impacts. Through this example, we show how qualitative research can tell a more complete story about complex community interventions. Copyright © 2015 Elsevier Inc. All rights reserved.

  15. The role of Clinical Trial Units in investigator- and industry-initiated research projects.

    Science.gov (United States)

    von Niederhäusern, Belinda; Fabbro, Thomas; Pauli-Magnus, Christiane

    2015-01-01

    Six multidisciplinary competence centres (Clinical Trial Units, CTUs) in Basel, Berne, Geneva, Lausanne, St. Gallen and Zurich provide professional support to clinical researchers in the planning, implementation, conduct and evaluation of clinical studies. Through their coordinated network, these units promote high-quality, nationally harmonised and internationally standardised clinical research conduct in Switzerland. We will describe why this network has been established, how it has been successful in stilling the growing need for clinical research support, which training and education opportunities it offers, and how it created national awareness for the still-existing hurdles towards clinical research excellence in Switzerland. Taking the CTU Basel as an example, we show that a considerable number (25%) of the studies submitted for regulatory approval in 2013 were supported by the CTU, decreasing the number of findings in ethics reviews by about one-third. We conclude that these achievements, together with a Swiss national funding model for clinical research, and improved national coordination, will be critical factors to successfully position Swiss clinical research at the international forefront.

  16. Reload core safety verification

    International Nuclear Information System (INIS)

    Svetlik, M.; Minarcin, M.

    2003-01-01

    This paper presents a brief look at the process of reload core safety evaluation and verification in Slovak Republic. It gives an overview of experimental verification of selected nuclear parameters in the course of physics testing during reactor start-up. The comparison of IAEA recommendations and testing procedures at Slovak and European nuclear power plants of similar design is included. An introduction of two level criteria for evaluation of tests represents an effort to formulate the relation between safety evaluation and measured values (Authors)

  17. Why do patients decline surgical trials? Findings from a qualitative interview study embedded in the Cancer Research UK BOLERO trial (Bladder cancer: Open versus Lapararoscopic or RObotic cystectomy).

    Science.gov (United States)

    Harrop, Emily; Kelly, John; Griffiths, Gareth; Casbard, Angela; Nelson, Annmarie

    2016-01-19

    Surgical trials have typically experienced recruitment difficulties when compared with other types of oncology trials. Qualitative studies have an important role to play in exploring reasons for low recruitment, although to date few such studies have been carried out that are embedded in surgical trials. The BOLERO trial (Bladder cancer: Open versus Lapararoscopic or RObotic cystectomy) is a study to determine the feasibility of randomisation to open versus laparoscopic access/robotic cystectomy in patients with bladder cancer. We describe the results of a qualitative study embedded within the clinical trial that explored why patients decline randomisation. Ten semi-structured interviews with patients who declined randomisation to the clinical trial, and two interviews with recruiting research nurses were conducted. Data were analysed for key themes. The majority of patients declined the trial because they had preferences for a particular treatment arm, and in usual practice could choose which surgical method they would be given. In most cases the robotic option was preferred. Patients described an intuitive 'sense' that favoured the new technology and had carried out their own inquiries, including Internet research and talking with previous patients and friends and family with medical backgrounds. Medical histories and lifestyle considerations also shaped these personalised choices. Of importance too, however, were the messages patients perceived from their clinical encounters. Whilst some patients felt their surgeon favoured the robotic option, others interpreted 'indirect' cues such as the 'established' reputation of the surgeon and surgical method and comments made during clinical assessments. Many patients expressed a wish for greater direction from their surgeon when making these decisions. For trials where the 'new technology' is available to patients, there will likely be difficulties with recruitment. Greater attention could be paid to how messages about

  18. Ethical and policy issues in cluster randomized trials: rationale and design of a mixed methods research study

    Directory of Open Access Journals (Sweden)

    Chaudhry Shazia H

    2009-07-01

    Full Text Available Abstract Background Cluster randomized trials are an increasingly important methodological tool in health research. In cluster randomized trials, intact social units or groups of individuals, such as medical practices, schools, or entire communities – rather than individual themselves – are randomly allocated to intervention or control conditions, while outcomes are then observed on individual cluster members. The substantial methodological differences between cluster randomized trials and conventional randomized trials pose serious challenges to the current conceptual framework for research ethics. The ethical implications of randomizing groups rather than individuals are not addressed in current research ethics guidelines, nor have they even been thoroughly explored. The main objectives of this research are to: (1 identify ethical issues arising in cluster trials and learn how they are currently being addressed; (2 understand how ethics reviews of cluster trials are carried out in different countries (Canada, the USA and the UK; (3 elicit the views and experiences of trial participants and cluster representatives; (4 develop well-grounded guidelines for the ethical conduct and review of cluster trials by conducting an extensive ethical analysis and organizing a consensus process; (5 disseminate the guidelines to researchers, research ethics boards (REBs, journal editors, and research funders. Methods We will use a mixed-methods (qualitative and quantitative approach incorporating both empirical and conceptual work. Empirical work will include a systematic review of a random sample of published trials, a survey and in-depth interviews with trialists, a survey of REBs, and in-depth interviews and focus group discussions with trial participants and gatekeepers. The empirical work will inform the concurrent ethical analysis which will lead to a guidance document laying out principles, policy options, and rationale for proposed guidelines. An

  19. A Missing Piece in Clinical Trial Inspections in Latin America: Interviews With Research Subjects in Peru.

    Science.gov (United States)

    Minaya, Gabriela E; Fuentes-Delgado, Duilio J; Ugalde, Antonio; Homedes, Núria

    2017-10-01

    Most regulatory agencies conduct clinical trial (CT) site inspections, but the experiences and behaviors of research subjects and their knowledge of the rights and obligations that ensue from participating in a CT are seldom explored. The authors assessed the technical feasibility of incorporating interviews with participants in CT inspections. This article analyzes the responses of 13 CT participants, 14% ( n = 96) of those included in three tuberculosis (TB) CTs. Participants did not object to being interviewed and provided information not obtained during regular inspections. Participants were appreciative of the agency's concern for the integrity of the CT process. Most interviewees did not understand the consent form and were unaware that they were participating in an experiment with unapproved new drugs. Participants' decision to enroll in CT related to undue inducement and therapeutic misconception. Some patients' behaviors, undisclosed to researchers, could have compromised the integrity of the data collected.

  20. Verification of Software Components: Addressing Unbounded Paralelism

    Czech Academy of Sciences Publication Activity Database

    Adámek, Jiří

    2007-01-01

    Roč. 8, č. 2 (2007), s. 300-309 ISSN 1525-9293 R&D Projects: GA AV ČR 1ET400300504 Institutional research plan: CEZ:AV0Z10300504 Keywords : software components * formal verification * unbounded parallelism Subject RIV: JC - Computer Hardware ; Software

  1. Behaviour Protocols Verification: Fighting State Explosion

    Czech Academy of Sciences Publication Activity Database

    Mach, M.; Plášil, František; Kofroň, Jan

    2005-01-01

    Roč. 6, č. 2 (2005), s. 22-30 ISSN 1525-9293 R&D Projects: GA ČR(CZ) GA102/03/0672 Institutional research plan: CEZ:AV0Z10300504 Keywords : formal verification * software components * stateexplos ion * behavior protocols * parse trees Subject RIV: JC - Computer Hardware ; Software

  2. Implementing a Randomized Controlled Trial through a Community-Academia Partnered Participatory Research: Arte con Salud Research-Informed Intervention.

    Science.gov (United States)

    Noboa-Ortega, Patricia; Figueroa-Cosme, Wanda I; Feldman-Soler, Alana; Miranda-Díaz, Christine

    2017-06-01

    "Arte con Salud" is an HIV/AIDS prevention intervention tailored for Puerto Rican women who have sex with men. The intervention curriculum was refined through a community-academic collaboration between Taller Salud, the UPRCayey Campus, and the UCC-School of Medicine, subsided in 2012-13 by PRCTRC. The collaboration has been crucial to validate the impact of using art as a tool to facilitate sexual negotiation skills and safer sexual practices among adult women have sex with men participating in HIV prevention education. This article describes the vision, valley, victory phases endured to establish a community-academia partnership based on the CPPR framework as an effective mean to implement a randomized controlled trial intervention (RCT). We also discuss the barriers, outcomes, and lessons learned from this partnership. Some of the identified solutions include: setting goals to secure funding, regular meetings, and the inclusion of undergraduate level students to assist in the implementation of the intervention. These solutions helped to build trust among the community and academic partners. As a result of this collaboration, a total of 86 participants were enrolled and 5 competitive research grants have been submitted. The community-academic collaboration was essential in order to build a solid research infrastructure that addresses the complexities of HIV prevention education among groups of Puerto Rican women.

  3. Is flow verification necessary

    International Nuclear Information System (INIS)

    Beetle, T.M.

    1986-01-01

    Safeguards test statistics are used in an attempt to detect diversion of special nuclear material. Under assumptions concerning possible manipulation (falsification) of safeguards accounting data, the effects on the statistics due to diversion and data manipulation are described algebraically. A comprehensive set of statistics that is capable of detecting any diversion of material is defined in terms of the algebraic properties of the effects. When the assumptions exclude collusion between persons in two material balance areas, then three sets of accounting statistics are shown to be comprehensive. Two of the sets contain widely known accountancy statistics. One of them does not require physical flow verification - comparisons of operator and inspector data for receipts and shipments. The third set contains a single statistic which does not require physical flow verification. In addition to not requiring technically difficult and expensive flow verification, this single statistic has several advantages over other comprehensive sets of statistics. This algebraic approach as an alternative to flow verification for safeguards accountancy is discussed in this paper

  4. Integrated Java Bytecode Verification

    DEFF Research Database (Denmark)

    Gal, Andreas; Probst, Christian; Franz, Michael

    2005-01-01

    Existing Java verifiers perform an iterative data-flow analysis to discover the unambiguous type of values stored on the stack or in registers. Our novel verification algorithm uses abstract interpretation to obtain definition/use information for each register and stack location in the program...

  5. Clinical Trials

    Medline Plus

    Full Text Available ... Entire Site NHLBI Entire Site Health Topics News & Resources Intramural Research ... or device is safe and effective for humans. What Are Clinical Trials? Clinical trials are research ...

  6. Clinical Trials

    Medline Plus

    Full Text Available ... decisionmaking. The purpose of clinical trials is research, so the studies follow strict scientific standards. These standards ... otherwise. The purpose of clinical trials is research, so the studies follow strict scientific standards. These standards ...

  7. Clinical Trials

    Medline Plus

    Full Text Available ... trials are research studies that explore whether a medical strategy, treatment, or device is safe and effective ... trials are research studies that explore whether a medical strategy, treatment, or device is safe and effective ...

  8. Clinical Trials

    Medline Plus

    Full Text Available ... treatment, or device is safe and effective for humans. What Are Clinical Trials? Clinical trials are research ... are required to have an IRB. Office for Human Research Protections The U.S. Department of Health and ...

  9. Clinical Trials

    Medline Plus

    Full Text Available ... best data available for health care decisionmaking. The purpose of clinical trials is research, so the studies ... Thus, research in humans is needed. For safety purposes, clinical trials start with small groups of patients ...

  10. Obstacles to researching the researchers: a case study of the ethical challenges of undertaking methodological research investigating the reporting of randomised controlled trials.

    Science.gov (United States)

    McKenzie, Joanne E; Herbison, G Peter; Roth, Paul; Paul, Charlotte

    2010-03-21

    Recent cohort studies of randomised controlled trials have provided evidence of within-study selective reporting bias; where statistically significant outcomes are more likely to be more completely reported compared to non-significant outcomes. Bias resulting from selective reporting can impact on meta-analyses, influencing the conclusions of systematic reviews, and in turn, evidence based clinical practice guidelines.In 2006 we received funding to investigate if there was evidence of within-study selective reporting in a cohort of RCTs submitted to New Zealand Regional Ethics Committees in 1998/99. This research involved accessing ethics applications, their amendments and annual reports, and comparing these with corresponding publications. We did not plan to obtain informed consent from trialists to view their ethics applications for practical and scientific reasons. In November 2006 we sought ethical approval to undertake the research from our institutional ethics committee. The Committee declined our application on the grounds that we were not obtaining informed consent from the trialists to view their ethics application. This initiated a seventeen month process to obtain ethical approval. This publication outlines what we planned to do, the issues we encountered, discusses the legal and ethical issues, and presents some potential solutions. Methodological research such as this has the potential for public benefit and there is little or no harm for the participants (trialists) in undertaking it. Further, in New Zealand, there is freedom of information legislation, which in this circumstance, unambiguously provided rights of access and use of the information in the ethics applications. The decision of our institutional ethics committee defeated this right and did not recognise the nature of this observational research. Methodological research, such as this, can be used to develop processes to improve quality in research reporting. Recognition of the potential

  11. Confronting challenges in intervention research with ethnically diverse older adults: the USC Well Elderly II Trial.

    Science.gov (United States)

    Jackson, Jeanne; Mandel, Deborah; Blanchard, Jeanine; Carlson, Mike; Cherry, Barbara; Azen, Stanley; Chou, Chih-Ping; Jordan-Marsh, Maryalice; Forman, Todd; White, Brett; Granger, Douglas; Knight, Bob; Clark, Florence

    2009-02-01

    Community-dwelling older adults are at risk for declines in physical health, cognition, and psychosocial well-being. However, their enactment of active and health-promoting lifestyles can reduce such declines. The purpose of this article is to describe the USC Well Elderly II study, a randomized clinical trial designed to test the effectiveness of a healthy lifestyle program for elders, and document how various methodological challenges were addressed during the course of the trial. In the study, 460 ethnically diverse elders recruited from a variety of sites in the urban Los Angeles area were enrolled in a randomized experiment involving a crossover design component. Within either the first or second 6-month phase of their study involvement, each elder received a lifestyle intervention designed to improve a variety of aging outcomes. At 4-5 time points over an 18-24 month interval, the research participants were assessed on measures of healthy activity, coping, social support, perceived control, stress-related biomarkers, perceived physical health, psychosocial well-being, and cognitive functioning to test the effectiveness of the intervention and document the process mechanisms responsible for its effects. The study protocol was successfully implemented, including the enrollment of study sites, the recruitment of 460 older adults, administration of the intervention, adherence to the plan for assessment, and establishment of a large computerized data base. Methodological challenges were encountered in the areas of site recruitment, participant recruitment, testing, and intervention delivery. The completion of clinical trials involving elders from numerous local sites requires careful oversight and anticipation of threats to the study design that stem from: (a) social situations that are particular to specific study sites; and (b) physical, functional, and social challenges pertaining to the elder population.

  12. Cluster randomized trial in the general practice research database: 2. Secondary prevention after first stroke (eCRT study: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Dregan Alex

    2012-10-01

    Full Text Available Abstract Background The purpose of this research is to develop and evaluate methods for conducting pragmatic cluster randomized trials in a primary care electronic database. The proposal describes one application, in a less frequent chronic condition of public health importance, secondary prevention of stroke. A related protocol in antibiotic prescribing was reported previously. Methods/Design The study aims to implement a cluster randomized trial (CRT using the electronic patient records of the General Practice Research Database (GPRD as a sampling frame and data source. The specific objective of the trial is to evaluate the effectiveness of a computer-delivered intervention at enhancing the delivery of stroke secondary prevention in primary care. GPRD family practices will be allocated to the intervention or usual care. The intervention promotes the use of electronic prompts to support adherence with the recommendations of the UK Intercollegiate Stroke Working Party and NICE guidelines for the secondary prevention of stroke in primary care. Primary outcome measure will be the difference in systolic blood pressure between intervention and control trial arms at 12-month follow-up. Secondary outcomes will be differences in serum cholesterol, prescribing of antihypertensive drugs, statins, and antiplatelet therapy. The intervention will continue for 12 months. Information on the utilization of the decision-support tools will also be analyzed. Discussion The CRT will investigate the effectiveness of using a computer-delivered intervention to reduce the risk of stroke recurrence following a first stroke event. The study will provide methodological guidance on the implementation of CRTs in electronic databases in primary care. Trial registration Current Controlled Trials ISRCTN35701810

  13. Involvement of consumers in studies run by the Medical Research Council Clinical Trials Unit: Results of a survey

    Directory of Open Access Journals (Sweden)

    Vale Claire L

    2012-01-01

    Full Text Available Abstract Background We aimed to establish levels of consumer involvement in randomised controlled trials (RCTs, meta-analyses and other studies carried out by the UK Medical Research Council (MRC Clinical Trials Unit across the range of research programs, predominantly in cancer and HIV. Methods Staff responsible for studies that were included in a Unit Progress Report (MRC CTU, April 2009 were asked to complete a semi-structured questionnaire survey regarding consumer involvement. This was defined as active involvement of consumers as partners in the research process and not as subjects of that research. The electronic questionnaires combined open and closed questions, intended to capture quantitative and qualitative information on whether studies had involved consumers; types of activities undertaken; recruitment and support; advantages and disadvantages of involvement and its perceived impact on aspects of the research. Results Between October 2009 and April 2010, 138 completed questionnaires (86% were returned. Studies had been conducted over a 20 year period from 1989, and around half were in cancer; 30% in HIV and 20% were in other disease areas including arthritis, tuberculosis and blood transfusion medicine. Forty-three studies (31% had some consumer involvement, most commonly as members of trial management groups (TMG [88%]. A number of positive impacts on both the research and the researcher were identified. Researchers generally felt involvement was worthwhile and some felt that consumer involvement had improved the credibility of the research. Benefits in design and quality, trial recruitment, dissemination and decision making were also perceived. Researchers felt they learned from consumer involvement, albeit that there were some barriers. Conclusions Whilst most researchers identified benefits of involving consumers, most of studies included in the survey had no involvement. Information from this survey will inform the development

  14. Involvement of consumers in studies run by the Medical Research Council Clinical Trials Unit: results of a survey.

    Science.gov (United States)

    Vale, Claire L; Thompson, Lindsay C; Murphy, Claire; Forcat, Silvia; Hanley, Bec

    2012-01-13

    We aimed to establish levels of consumer involvement in randomised controlled trials (RCTs), meta-analyses and other studies carried out by the UK Medical Research Council (MRC) Clinical Trials Unit across the range of research programs, predominantly in cancer and HIV. Staff responsible for studies that were included in a Unit Progress Report (MRC CTU, April 2009) were asked to complete a semi-structured questionnaire survey regarding consumer involvement. This was defined as active involvement of consumers as partners in the research process and not as subjects of that research. The electronic questionnaires combined open and closed questions, intended to capture quantitative and qualitative information on whether studies had involved consumers; types of activities undertaken; recruitment and support; advantages and disadvantages of involvement and its perceived impact on aspects of the research. Between October 2009 and April 2010, 138 completed questionnaires (86%) were returned. Studies had been conducted over a 20 year period from 1989, and around half were in cancer; 30% in HIV and 20% were in other disease areas including arthritis, tuberculosis and blood transfusion medicine. Forty-three studies (31%) had some consumer involvement, most commonly as members of trial management groups (TMG) [88%]. A number of positive impacts on both the research and the researcher were identified. Researchers generally felt involvement was worthwhile and some felt that consumer involvement had improved the credibility of the research. Benefits in design and quality, trial recruitment, dissemination and decision making were also perceived. Researchers felt they learned from consumer involvement, albeit that there were some barriers. Whilst most researchers identified benefits of involving consumers, most of studies included in the survey had no involvement. Information from this survey will inform the development of a unit policy on consumer involvement, to guide future

  15. Verification Games: Crowd-Sourced Formal Verification

    Science.gov (United States)

    2016-03-01

    additional paintbrushes. Additionally, in Paradox , human players are never given small optimization problems (for example, toggling the values of 50...were developed by the Center for Game Science: Pipe Jam, Traffic Jam, Flow Jam and Paradox . Verification tools and games were integrated to verify...4 4. Paradox …………………………………………………......5 5. MyClass ………………………………………………….....7 6. Results …………………………………………………......11 7. Time to

  16. Pharmacy Students’ Knowledge and Attitude toward Registration Trials and Clinical Research: A Survey in a Japanese University Hospital

    Directory of Open Access Journals (Sweden)

    Natsuko Ise

    2017-12-01

    Full Text Available Clinical research plays a fundamental role in establishing new treatments. Clinical research coordinators are considered essential in clinical research, and medical professionals such as pharmacists often take on this role. Pharmacy students can be considered future candidates for this task. We used questionnaires to survey the knowledge of and attitudes toward registration trials and clinical research of pharmacy students at Tokushima University Hospital. All pharmacy students (103 to whom questionnaires were sent responded. Almost all respondents were aware of registration trials and clinical research. More than 90% were aware of the existence of clinical research coordinators, and about half (48.6% understood their role. In clinical research terminology, most respondents were aware of informed consent and related issues, but fewer than 20% were aware of more practical things. In total, 29.1% and 40.8% of the respondents were willing to carry out and coordinate research. These findings suggest that pharmacy students have basic knowledge of clinical research and that many students are willing to carry out and coordinate clinical research. More practical exposure to clinical research may help to strengthen their future contribution. Further studies may help to determine how to provide education on registration trials and clinical research to pharmacy students.

  17. The design of verification regimes

    International Nuclear Information System (INIS)

    Gallagher, N.W.

    1991-01-01

    Verification of a nuclear agreement requires more than knowledge of relevant technologies and institutional arrangements. It also demands thorough understanding of the nature of verification and the politics of verification design. Arms control efforts have been stymied in the past because key players agreed to verification in principle, only to disagree radically over verification in practice. In this chapter, it is shown that the success and stability of arms control endeavors can be undermined by verification designs which promote unilateral rather than cooperative approaches to security, and which may reduce, rather than enhance, the security of both sides. Drawing on logical analysis and practical lessons from previous superpower verification experience, this chapter summarizes the logic and politics of verification and suggests implications for South Asia. The discussion begins by determining what properties all forms of verification have in common, regardless of the participants or the substance and form of their agreement. Viewing verification as the political process of making decisions regarding the occurrence of cooperation points to four critical components: (1) determination of principles, (2) information gathering, (3) analysis and (4) projection. It is shown that verification arrangements differ primarily in regards to how effectively and by whom these four stages are carried out

  18. The participation of minors in preventive HIV research trials in South Africa: legal and human rights considerations.

    Science.gov (United States)

    van Wyk, Christa

    2003-01-01

    The constitutional prohibition of experimentation/research without the individual subject's (own) consent is investigated. A distinction is drawn between therapeutic and non-therapeutic research. A minor of 14 is competent to consent independently to medical treatment (which would include therapeutic research), but not to non-therapeutic research. A minor must be at least 18 years to be able to do so. Proxy consent can be secured for the participation of minors under 18 in non-therapeutic research only if they assent, if their participation in the research is indispensable and the research carries no more than negligible risk. Since the risks inherent in HIV preventive vaccine trials may carry more than negligible risk, these trials may not be carried out on children under 18. The limitation of rights and the consideration of foreign and international law in the interpretation of the South African Bill of Rights are investigated.

  19. The research gap in chronic paediatric pain: A systematic review of randomised controlled trials.

    Science.gov (United States)

    Boulkedid, R; Abdou, A Y; Desselas, E; Monégat, M; de Leeuw, T G; Avez-Couturier, J; Dugue, S; Mareau, C; Charron, B; Alberti, C; Kaguelidou, F

    2018-02-01

    Chronic pain is associated with significant functional and social impairment. The objective of this review was to assess the characteristics and quality of randomized controlled trials (RCTs) evaluating pain management interventions in children and adolescents with chronic pain. We performed a systematic search of PubMed, Embase and the Cochrane Library up to July 2017. We included RCTs that involved children and adolescents (3 months-18 years) and evaluated the use of pharmacological or non-pharmacological intervention(s) in the context of pain persisting or re-occurring for more than 3 months. Methodological quality was evaluated using the Cochrane Risk of Bias (ROB) Tool. A total of 58 RCTs were identified and numbers steadily increased over time. The majority were conducted in single hospital institutions, with no information on study funding. Median sample size was 47.5 participants (Q1,Q3: 32, 70). Forty-five percent of RCTs included both adults and children and the median of the mean ages at inclusion was 12.9 years (Q1,Q3: 11, 15). Testing of non-pharmacological interventions was predominant and only 5 RCTs evaluated analgesics or co-analgesics. Abdominal pain, headache/migraine and musculoskeletal pain were the most common types of chronic pain among participants. Methodological quality was poor with 90% of RCTs presenting a high or unclear ROB. Evaluation of analgesics targeting chronic pain relief in children and adolescents through RCTs is marginal. Infants and children with long-lasting painful conditions are insufficiently represented in RCTs. We discuss possible research constraints and challenges as well as methodologies to circumvent them. There is a substantial research gap regarding analgesic interventions for children and adolescents with chronic pain. Most clinical trials in the field focus on the evaluation of non-pharmacological interventions and are of low methodological quality. There is also a specific lack of trials involving infants

  20. Preventing Obesity in the Military Community (POMC): The Development of a Clinical Trials Research Network

    Science.gov (United States)

    Spieker, Elena A.; Sbrocco, Tracy; Theim, Kelly R.; Maurer, Douglas; Johnson, Dawn; Bryant, Edny; Bakalar, Jennifer L.; Schvey, Natasha A.; Ress, Rachel; Seehusen, Dean; Klein, David A.; Stice, Eric; Yanovski, Jack A.; Chan, Linda; Gentry, Shari; Ellsworth, Carol; Hill, Joanne W.; Tanofsky-Kraff, Marian; Stephens, Mark B.

    2015-01-01

    Obesity impacts the U.S. military by affecting the health and readiness of active duty service members and their families. Preventing Obesity in Military Communities (POMC) is a comprehensive research program within Patient Centered Medical Homes (PCMHs) in three Military Training Facilities. This paper describes three pilot randomized controlled trials that target critical high risk periods for unhealthy weight gain from birth to young adulthood: (1) pregnancy and early infancy (POMC-Mother-Baby), (2) adolescence (POMC-Adolescent), and (3) the first tour of duty after boot camp (POMC-Early Career). Each study employs a two-group randomized treatment or prevention program with follow up. POMC offers a unique opportunity to bring together research and clinical expertise in obesity prevention to develop state-of-the-art programs within PCMHs in Military Training Facilities. This research builds on existing infrastructure that is expected to have immediate clinical benefits to DoD and far-reaching potential for ongoing collaborative work. POMC may offer an economical approach for widespread obesity prevention, from conception to young adulthood, in the U.S. military as well as in civilian communities. PMID:25648176

  1. Greenshell™ Mussels: A Review of Veterinary Trials and Future Research Directions

    Directory of Open Access Journals (Sweden)

    Charles T. Eason

    2018-03-01

    Full Text Available The therapeutic benefits of Greenshell™ mussel (GSM; Perna canaliculus preparations have been studied using in vitro test systems, animal models, and human clinical trials focusing mainly on anti-inflammatory and anti-arthritic effects. Activity is thought to be linked to key active ingredients that include omega-3 polyunsaturated fatty acids, a variety of carotenoids and other bioactive compounds. In this paper, we review the studies that have been undertaken in dogs, cats, and horses, and outline new research directions in shellfish breeding and high-value nutrition research programmes targeted at enhancing the efficacy of mussel and algal extracts. The addition of GSM to animal diets has alleviated feline degenerative joint disease and arthritis symptoms, and chronic orthopaedic pain in dogs. In horses, GSM extracts decreased the severity of lameness and joint pain and provided improved joint flexion in limbs with lameness attributed to osteoarthritis. Future research in this area should focus on elucidating the key active ingredients in order to link concentrations of these active ingredients with their pharmacokinetics and therapeutic effects. This would enable consistent and improved efficacy from GSM-based products for the purpose of improved animal health.

  2. Types of Cancer Clinical Trials

    Science.gov (United States)

    Information about the several types of cancer clinical trials, including treatment trials, prevention trials, screening trials, supportive and palliative care trials. Each type of trial is designed to answer different research questions.

  3. Report on achievements in fiscal 1999 of energy and environment technology verification project formation assisting project and international joint verification and research project. Verification of discrete power generation system utilizing mini-power generation that utilizes micro gas turbine; 1999 nendo micro gas turbine riyo mini hatsuden wo riyoshita bunsangata hatsuden system no kensho seika hokokusho

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2000-03-01

    This paper describes the verification test on power generation by using natural gas driven micro gas turbines (rated at 28 kW) in Thailand. The turbine presented excellent result of providing a maximum power generation output of 25 kW, having no efficiency deterioration even at the 50% output point (about 22%). Its exhaust gas emitted under the normal operation is clean. The waste heat is as low as 290 degrees C, which can be used for hot water supply, but may be difficult for steam generation. Under the severe condition for building large power plants in remote areas due to environmental issues and power transmission loss, proliferation of the discrete power generation system in the suburbs of the city of Bangkok draws expectation. This system can be more advantageous than the existing facilities if the end user gas price is 6.7 Bht/m{sup 3} or less. Discussions were given on a hybrid electric vehicle (HEV) bus driven by electric power generated from the gas turbine mounted on the bus. The bus is overwhelmingly superior in the environmental aspect to diesel fueled buses. The HEV bus emits no black smoke at all, and NOx emission is as low as about 1/70. Fuel consumption is less than half (when regenerative braking is used). However, the vehicle body cost is higher by 40%. Smooth operation of the buses requires indispensably deployment of compressed natural gas service stations (to be located at 40-km interval ideally). Assistance is required also on the fund for gas line installations, and civil engineering construction technologies. (NEDO)

  4. CYberinfrastructure for COmparative effectiveness REsearch (CYCORE): improving data from cancer clinical trials.

    Science.gov (United States)

    Patrick, Kevin; Wolszon, Laura; Basen-Engquist, Karen M; Demark-Wahnefried, Wendy; Prokhorov, Alex V; Barrera, Stephanie; Baru, Chaitan; Farcas, Emilia; Krueger, Ingolf; Palmer, Doug; Raab, Fred; Rios, Phil; Ziftci, Celal; Peterson, Susan

    2011-03-01

    Improved approaches and methodologies are needed to conduct comparative effectiveness research (CER) in oncology. While cancer therapies continue to emerge at a rapid pace, the review, synthesis, and dissemination of evidence-based interventions across clinical trials lag in comparison. Rigorous and systematic testing of competing therapies has been clouded by age-old problems: poor patient adherence, inability to objectively measure the environmental influences on health, lack of knowledge about patients' lifestyle behaviors that may affect cancer's progression and recurrence, and limited ability to compile and interpret the wide range of variables that must be considered in the cancer treatment. This lack of data integration limits the potential for patients and clinicians to engage in fully informed decision-making regarding cancer prevention, treatment, and survivorship care, and the translation of research results into mainstream medical care. Particularly important, as noted in a 2009 report on CER to the President and Congress, the limited focus on health behavior-change interventions was a major hindrance in this research landscape (DHHS 2009). This paper describes an initiative to improve CER for cancer by addressing several of these limitations. The Cyberinfrastructure for Comparative Effectiveness Research (CYCORE) project, informed by the National Science Foundation's 2007 report "Cyberinfrastructure Vision for 21(st) Century Discovery" has, as its central aim, the creation of a prototype for a user-friendly, open-source cyberinfrastructure (CI) that supports acquisition, storage, visualization, analysis, and sharing of data important for cancer-related CER. Although still under development, the process of gathering requirements for CYCORE has revealed new ways in which CI design can significantly improve the collection and analysis of a wide variety of data types, and has resulted in new and important partnerships among cancer researchers engaged in

  5. Using Mechanical Turk to recruit participants for internet intervention research: experience from recruitment for four trials targeting hazardous alcohol consumption.

    Science.gov (United States)

    Cunningham, John A; Godinho, Alexandra; Kushnir, Vladyslav

    2017-12-01

    Mechanical Turk (MTurk) is an online portal operated by Amazon where 'requesters' (individuals or businesses) can submit jobs for 'workers.' MTurk is used extensively by academics as a quick and cheap means of collecting questionnaire data, including information on alcohol consumption, from a diverse sample of participants. We tested the feasibility of recruiting for alcohol Internet intervention trials through MTurk. Participants, 18 years or older, who drank at least weekly were recruited for four intervention trials (combined sample size, N = 11,107). The same basic recruitment strategy was employed for each trial - invite participants to complete a survey about alcohol consumption (less than 15 min in length, US$1.50 payment), identify eligible participants who drank in a hazardous fashion, invite those eligible to complete a follow-up survey ($10 payment), randomize participants to be sent or not sent information to access an online intervention for hazardous alcohol use. Procedures where put in place to optimize the chances that participants could only complete the baseline survey once. There was a substantially slower rate of recruitment by the fourth trial compared to the earlier trials. Demographic characteristics also varied across trials (age, sex, employment and marital status). Patterns of alcohol consumption, while displaying some differences, did not appear to vary in a linear fashion between trials. It is possible to recruit large (but not inexhaustible) numbers of people who drink in a hazardous fashion. Issues for online intervention research when employing this sample are discussed.

  6. Promoting advance planning for health care and research among older adults: A randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Bravo Gina

    2012-01-01

    Full Text Available Abstract Background Family members are often required to act as substitute decision-makers when health care or research participation decisions must be made for an incapacitated relative. Yet most families are unable to accurately predict older adult preferences regarding future health care and willingness to engage in research studies. Discussion and documentation of preferences could improve proxies' abilities to decide for their loved ones. This trial assesses the efficacy of an advance planning intervention in improving the accuracy of substitute decision-making and increasing the frequency of documented preferences for health care and research. It also investigates the financial impact on the healthcare system of improving substitute decision-making. Methods/Design Dyads (n = 240 comprising an older adult and his/her self-selected proxy are randomly allocated to the experimental or control group, after stratification for type of designated proxy and self-report of prior documentation of healthcare preferences. At baseline, clinical and research vignettes are used to elicit older adult preferences and assess the ability of their proxy to predict those preferences. Responses are elicited under four health states, ranging from the subject's current health state to severe dementia. For each state, we estimated the public costs of the healthcare services that would typically be provided to a patient under these scenarios. Experimental dyads are visited at home, twice, by a specially trained facilitator who communicates the dyad-specific results of the concordance assessment, helps older adults convey their wishes to their proxies, and offers assistance in completing a guide entitled My Preferences that we designed specifically for that purpose. In between these meetings, experimental dyads attend a group information session about My Preferences. Control dyads attend three monthly workshops aimed at promoting healthy behaviors. Concordance

  7. Distorted Fingerprint Verification System

    Directory of Open Access Journals (Sweden)

    Divya KARTHIKAESHWARAN

    2011-01-01

    Full Text Available Fingerprint verification is one of the most reliable personal identification methods. Fingerprint matching is affected by non-linear distortion introduced in fingerprint impression during the image acquisition process. This non-linear deformation changes both the position and orientation of minutiae. The proposed system operates in three stages: alignment based fingerprint matching, fuzzy clustering and classifier framework. First, an enhanced input fingerprint image has been aligned with the template fingerprint image and matching score is computed. To improve the performance of the system, a fuzzy clustering based on distance and density has been used to cluster the feature set obtained from the fingerprint matcher. Finally a classifier framework has been developed and found that cost sensitive classifier produces better results. The system has been evaluated on fingerprint database and the experimental result shows that system produces a verification rate of 96%. This system plays an important role in forensic and civilian applications.

  8. RESRAD-BUILD verification

    International Nuclear Information System (INIS)

    Kamboj, S.; Yu, C.; Biwer, B. M.; Klett, T.

    2002-01-01

    The results generated by the RESRAD-BUILD code (version 3.0) were verified with hand or spreadsheet calculations using equations given in the RESRAD-BUILD manual for different pathways. For verification purposes, different radionuclides--H-3, C-14, Na-22, Al-26, Cl-36, Mn-54, Co-60, Au-195, Ra-226, Ra-228, Th-228, and U-238--were chosen to test all pathways and models. Tritium, Ra-226, and Th-228 were chosen because of the special tritium and radon models in the RESRAD-BUILD code. Other radionuclides were selected to represent a spectrum of radiation types and energies. Verification of the RESRAD-BUILD code was conducted with an initial check of all the input parameters for correctness against their original source documents. Verification of the calculations was performed external to the RESRAD-BUILD code with Microsoft Excel to verify all the major portions of the code. In some cases, RESRAD-BUILD results were compared with those of external codes, such as MCNP (Monte Carlo N-particle) and RESRAD. The verification was conducted on a step-by-step basis and used different test cases as templates. The following types of calculations were investigated: (1) source injection rate, (2) air concentration in the room, (3) air particulate deposition, (4) radon pathway model, (5) tritium model for volume source, (6) external exposure model, (7) different pathway doses, and (8) time dependence of dose. Some minor errors were identified in version 3.0; these errors have been corrected in later versions of the code. Some possible improvements in the code were also identified

  9. Methods of Software Verification

    Directory of Open Access Journals (Sweden)

    R. E. Gurin

    2015-01-01

    Full Text Available This article is devoted to the problem of software verification (SW. Methods of software verification designed to check the software for compliance with the stated requirements such as correctness, system security and system adaptability to small changes in the environment, portability and compatibility, etc. These are various methods both by the operation process and by the way of achieving result. The article describes the static and dynamic methods of software verification and paid attention to the method of symbolic execution. In its review of static analysis are discussed and described the deductive method, and methods for testing the model. A relevant issue of the pros and cons of a particular method is emphasized. The article considers classification of test techniques for each method. In this paper we present and analyze the characteristics and mechanisms of the static analysis of dependencies, as well as their views, which can reduce the number of false positives in situations where the current state of the program combines two or more states obtained both in different paths of execution and in working with multiple object values. Dependences connect various types of software objects: single variables, the elements of composite variables (structure fields, array elements, the size of the heap areas, the length of lines, the number of initialized array elements in the verification code using static methods. The article pays attention to the identification of dependencies within the framework of the abstract interpretation, as well as gives an overview and analysis of the inference tools.Methods of dynamic analysis such as testing, monitoring and profiling are presented and analyzed. Also some kinds of tools are considered which can be applied to the software when using the methods of dynamic analysis. Based on the work a conclusion is drawn, which describes the most relevant problems of analysis techniques, methods of their solutions and

  10. Material integrity verification radar

    International Nuclear Information System (INIS)

    Koppenjan, S.K.

    1999-01-01

    The International Atomic Energy Agency (IAEA) has the need for verification of 'as-built' spent fuel-dry storage containers and other concrete structures. The IAEA has tasked the Special Technologies Laboratory (STL) to fabricate, test, and deploy a stepped-frequency Material Integrity Verification Radar (MIVR) system to nondestructively verify the internal construction of these containers. The MIVR system is based on previously deployed high-frequency, ground penetrating radar (GPR) systems that have been developed by STL for the U.S. Department of Energy (DOE). Whereas GPR technology utilizes microwave radio frequency energy to create subsurface images, MTVR is a variation for which the medium is concrete instead of soil. The purpose is to nondestructively verify the placement of concrete-reinforcing materials, pipes, inner liners, and other attributes of the internal construction. The MIVR system underwent an initial field test on CANDU reactor spent fuel storage canisters at Atomic Energy of Canada Limited (AECL), Chalk River Laboratories, Ontario, Canada, in October 1995. A second field test at the Embalse Nuclear Power Plant in Embalse, Argentina, was completed in May 1996. The DOE GPR also was demonstrated at the site. Data collection and analysis were performed for the Argentine National Board of Nuclear Regulation (ENREN). IAEA and the Brazilian-Argentine Agency for the Control and Accounting of Nuclear Material (ABACC) personnel were present as observers during the test. Reinforcing materials were evident in the color, two-dimensional images produced by the MIVR system. A continuous pattern of reinforcing bars was evident and accurate estimates on the spacing, depth, and size were made. The potential uses for safeguard applications were jointly discussed. The MIVR system, as successfully demonstrated in the two field tests, can be used as a design verification tool for IAEA safeguards. A deployment of MIVR for Design Information Questionnaire (DIQ

  11. Can self-verification strivings fully transcend the self-other barrier? Seeking verification of ingroup identities.

    Science.gov (United States)

    Gómez, Angel; Seyle, D Conor; Huici, Carmen; Swann, William B

    2009-12-01

    Recent research has demonstrated self-verification strivings in groups, such that people strive to verify collective identities, which are personal self-views (e.g., "sensitive") associated with group membership (e.g., "women"). Such demonstrations stop short of showing that the desire for self-verification can fully transcend the self-other barrier, as in people working to verify ingroup identities (e.g., "Americans are loud") even when such identities are not self-descriptive ("I am quiet and unassuming"). Five studies focus on such ingroup verification strivings. Results indicate that people prefer to interact with individuals who verify their ingroup identities over those who enhance these identities (Experiments 1-5). Strivings for ingroup identity verification were independent of the extent to which the identities were self-descriptive but were stronger among participants who were highly invested in their ingroup identities, as reflected in high certainty of these identities (Experiments 1-4) and high identification with the group (Experiments 1-5). In addition, whereas past demonstrations of self-verification strivings have been limited to efforts to verify the content of identities (Experiments 1 to 3), the findings also show that they strive to verify the valence of their identities (i.e., the extent to which the identities are valued; Experiments 4 and 5). Self-verification strivings, rather than self-enhancement strivings, appeared to motivate participants' strivings for ingroup identity verification. Links to collective self-verification strivings and social identity theory are discussed.

  12. Spent fuel verification options for final repository safeguards in Finland. A study on verification methods, their feasibility and safety aspects

    International Nuclear Information System (INIS)

    Hautamaeki, J.; Tiitta, A.

    2000-12-01

    The verification possibilities of the spent fuel assemblies from the Olkiluoto and Loviisa NPPs and the fuel rods from the research reactor of VTT are contemplated in this report. The spent fuel assemblies have to be verified at the partial defect level before the final disposal into the geologic repository. The rods from the research reactor may be verified at the gross defect level. Developing a measurement system for partial defect verification is a complicated and time-consuming task. The Passive High Energy Gamma Emission Tomography and the Fork Detector combined with Gamma Spectrometry are the most potential measurement principles to be developed for this purpose. The whole verification process has to be planned to be as slick as possible. An early start in the planning of the verification and developing the measurement devices is important in order to enable a smooth integration of the verification measurements into the conditioning and disposal process. The IAEA and Euratom have not yet concluded the safeguards criteria for the final disposal. E.g. criteria connected to the selection of the best place to perform the verification. Measurements have not yet been concluded. Options for the verification places have been considered in this report. One option for a verification measurement place is the intermediate storage. The other option is the encapsulation plant. Crucial viewpoints are such as which one offers the best practical possibilities to perform the measurements effectively and which would be the better place in the safeguards point of view. Verification measurements may be needed both in the intermediate storages and in the encapsulation plant. In this report also the integrity of the fuel assemblies after wet intermediate storage period is assessed, because the assemblies have to stand the handling operations of the verification measurements. (orig.)

  13. Collaborative research between academia and industry using a large clinical trial database: a case study in Alzheimer's disease

    DEFF Research Database (Denmark)

    Jones, Roy; Wilkinson, David; Lopez, Oscar L

    2011-01-01

    Large clinical trials databases, developed over the course of a comprehensive clinical trial programme, represent an invaluable resource for clinical researchers. Data mining projects sponsored by industry that use these databases, however, are often not viewed favourably in the academic medical...... community because of concerns that commercial, rather than scientific, goals are the primary purpose of such endeavours. Thus, there are few examples of sustained collaboration between leading academic clinical researchers and industry professionals in a large-scale data mining project. We present here...

  14. A multimedia consent tool for research participants in the Gambia: a randomized controlled trial.

    Science.gov (United States)

    Afolabi, Muhammed Olanrewaju; McGrath, Nuala; D'Alessandro, Umberto; Kampmann, Beate; Imoukhuede, Egeruan B; Ravinetto, Raffaella M; Alexander, Neal; Larson, Heidi J; Chandramohan, Daniel; Bojang, Kalifa

    2015-05-01

    To assess the effectiveness of a multimedia informed consent tool for adults participating in a clinical trial in the Gambia. Adults eligible for inclusion in a malaria treatment trial (n = 311) were randomized to receive information needed for informed consent using either a multimedia tool (intervention arm) or a standard procedure (control arm). A computerized, audio questionnaire was used to assess participants' comprehension of informed consent. This was done immediately after consent had been obtained (at day 0) and at subsequent follow-up visits (days 7, 14, 21 and 28). The acceptability and ease of use of the multimedia tool were assessed in focus groups. On day 0, the median comprehension score in the intervention arm was 64% compared with 40% in the control arm (P = 0.042). The difference remained significant at all follow-up visits. Poorer comprehension was independently associated with female sex (odds ratio, OR: 0.29; 95% confidence interval, CI: 0.12-0.70) and residing in Jahaly rather than Basse province (OR: 0.33; 95% CI: 0.13-0.82). There was no significant independent association with educational level. The risk that a participant's comprehension score would drop to half of the initial value was lower in the intervention arm (hazard ratio 0.22, 95% CI: 0.16-0.31). Overall, 70% (42/60) of focus group participants from the intervention arm found the multimedia tool clear and easy to understand. A multimedia informed consent tool significantly improved comprehension and retention of consent information by research participants with low levels of literacy.

  15. What Difference Does Patient and Public Involvement Make and What Are Its Pathways to Impact? Qualitative Study of Patients and Researchers from a Cohort of Randomised Clinical Trials.

    Directory of Open Access Journals (Sweden)

    Louise Dudley

    Full Text Available Patient and public involvement (PPI is advocated in clinical trials yet evidence on how to optimise its impact is limited. We explored researchers' and PPI contributors' accounts of the impact of PPI within trials and factors likely to influence its impact.Semi-structured qualitative interviews with researchers and PPI contributors accessed through a cohort of randomised clinical trials. Analysis of transcripts of audio-recorded interviews was informed by the principles of the constant comparative method, elements of content analysis and informant triangulation.We interviewed 21 chief investigators, 10 trial managers and 17 PPI contributors from 28 trials. The accounts of informants within the same trials were largely in agreement. Over half the informants indicted PPI had made a difference within a trial, through contributions that influenced either an aspect of a trial, or how researchers thought about a trial. According to informants, the opportunity for PPI to make a difference was influenced by two main factors: whether chief investigators had goals and plans for PPI and the quality of the relationship between the research team and the PPI contributors. Early involvement of PPI contributors and including them in responsive (e.g. advisory groups and managerial (e.g. trial management groups roles were more likely to achieve impact compared to late involvement and oversight roles (e.g. trial steering committees.Those seeking to enhance PPI in trials should develop goals for PPI at an early stage that fits the needs of the trial, plan PPI implementation in accordance with these goals, invest in developing good relationships between PPI contributors and researchers, and favour responsive and managerial roles for contributors in preference to oversight-only roles. These features could be used by research funders in judging PPI in trial grant applications and to inform policies to optimise PPI within trials.

  16. Clinical Trials

    Medline Plus

    Full Text Available ... Health Topics / About Clinical Trials About Clinical Trials Clinical trials are research studies that explore whether a medical strategy, treatment, ... tool for advancing medical knowledge and patient care. Clinical research is done only if doctors don't know ...

  17. Quantum money with classical verification

    Energy Technology Data Exchange (ETDEWEB)

    Gavinsky, Dmitry [NEC Laboratories America, Princeton, NJ (United States)

    2014-12-04

    We propose and construct a quantum money scheme that allows verification through classical communication with a bank. This is the first demonstration that a secure quantum money scheme exists that does not require quantum communication for coin verification. Our scheme is secure against adaptive adversaries - this property is not directly related to the possibility of classical verification, nevertheless none of the earlier quantum money constructions is known to possess it.

  18. Quantum money with classical verification

    International Nuclear Information System (INIS)

    Gavinsky, Dmitry

    2014-01-01

    We propose and construct a quantum money scheme that allows verification through classical communication with a bank. This is the first demonstration that a secure quantum money scheme exists that does not require quantum communication for coin verification. Our scheme is secure against adaptive adversaries - this property is not directly related to the possibility of classical verification, nevertheless none of the earlier quantum money constructions is known to possess it

  19. Research design considerations for single-dose analgesic clinical trials in acute pain

    DEFF Research Database (Denmark)

    Cooper, Stephen A; Desjardins, Paul J; Turk, Dennis C

    2016-01-01

    This article summarizes the results of a meeting convened by the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) on key considerations and best practices governing the design of acute pain clinical trials. We discuss the role of early phase clinical trials......, including pharmacokinetic-pharmacodynamic (PK-PD) trials, and the value of including both placebo and active standards of comparison in acute pain trials. This article focuses on single-dose and short-duration trials with emphasis on the perioperative and study design factors that influence assay...... sensitivity. Recommendations are presented on assessment measures, study designs, and operational factors. Although most of the methodological advances have come from studies of postoperative pain after dental impaction, bunionectomy, and other surgeries, the design considerations discussed are applicable...

  20. The Cervix Cancer Research Network (CCRN: Increasing access to cancer clinical trials in low- and middle-income countries

    Directory of Open Access Journals (Sweden)

    Gita eSuneja

    2015-02-01

    Full Text Available Introduction: The burden of cervical cancer is large and growing in developing countries, due in large part to limited access to screening services and lack of human papillomavirus (HPV vaccination. In spite of modern advances in diagnostic and therapeutic modalities, outcomes from cervical cancer have not markedly improved in recent years. Novel clinical trials are urgently needed to improve outcomes from cervical cancer worldwide. Methods: The Cervix Cancer Research Network (CCRN, a subsidiary of the Gynecologic Cancer InterGroup (GCIG, is a multi-national, multi-institutional consortium of physicians and scientists focused on improving cervical cancer outcomes worldwide by making cancer clinical trials available in low-, middle-, and high-income countries. Standard operating procedures for participation in CCRN include a pre-qualifying questionnaire to evaluate clinical activities and research infrastructure, followed by a site visit. Once a site is approved, they may choose to participate in one of four currently accruing clinical trials.Results: To date, 13 different CCRN site visits have been performed. Of these 13 sites visited, 10 have been approved as CCRN sites including Tata Memorial Hospital, India; Bangalore, India; Trivandrum, India; Ramathibodi, Thailand; Siriaj, Thailand; Pramongkutklao, Thailand; Ho Chi Minh, Vietnam; Blokhin Russian Cancer Research Center; the Hertzen Moscow Cancer Research Institute; and the Russian Scientific Center of Roentgenoradiology. The four currently accruing clinical trials are TACO, OUTBACK, INTERLACE, and SHAPE.Discussion: The CCRN has successfully enrolled 10 sites in developing countries to participate in four randomized clinical trials. The primary objectives are to provide novel therapeutics to regions with the greatest need and to improve the validity and generalizability of clinical trial results by enrolling a diverse sample of patients.

  1. Informing potential participants about research: observational study with an embedded randomized controlled trial.

    Directory of Open Access Journals (Sweden)

    Helen M Kirkby

    Full Text Available OBJECTIVES: To assess: 1 the feasibility of electronic information provision; 2 gather evidence on the topics and level of detail of information potential research participant's accessed; 3 to assess satisfaction and understanding. DESIGN: Observational study with an embedded randomised controlled trial. SETTING: Low risk intervention study based in primary care. PARTICIPANTS: White British & Irish, South Asian and African-Caribbean subjects aged between 40-74 years eligible for a blood pressure monitoring study. INTERVENTIONS: PDF copy of the standard paper participant information sheet (PDF-PIS and an electronic Interactive Information Sheet (IIS where participants could choose both the type and level of detail accessed. MAIN OUTCOME MEASURES: 1 Proportion of participants providing an email address and accessing electronic information 2 Willingness to participate in a recruitment clinic. 3 Type and depth of information accessed on the IIS. 4 Participant satisfaction and understanding. RESULTS: 1160 participants were eligible for the study. Of these, 276 (24% provided an active email address, of whom 84 did not respond to the email. 106 responded to the email but chose not to access any electronic information and were therefore ineligible for randomisation. 42 were randomised to receive the PDF-PIS and 44 to receive the IIS (with consent rates of 48% and 36%, respectively; odds ratio 0.6, 95% confidence interval 0.25 to 1.4. Electronic observation of information accessed by potential participants showed 41% chose to access no information and only 9% accessed the detail presented on the Research Ethics Committee approved participant information sheet before booking to attend a recruitment clinic for the intervention study. 63 of the 106 participants (59% who chose not to access any electronic information also booked an appointment. CONCLUSIONS: Current written information about research may not be read, emphasising the importance of the consent

  2. FINAL INTERIM REPORT VERIFICATION SURVEY ACTIVITIES IN FINAL STATUS SURVEY UNITS 7, 8, 9, 10, 11, 13 and 14 AT THE SEPARATIONS PROCESS RESEARCH UNIT, NISKAYUNA, NEW YORK

    International Nuclear Information System (INIS)

    Jadick, M.G.

    2010-01-01

    The Separations Process Research Unit (SPRU) facilities were constructed in the late 1940s to research the chemical separation of plutonium and uranium. SPRU operated between February 1950 and October 1953. The research activities ceased following the successful development of the reduction/oxidation and plutonium/uranium extraction processes that were subsequently used by the Hanford and the Savannah River sites.

  3. Achievement report on developing superconductor power applied technologies in fiscal 1999 (1). Research and development of superconductor wire materials, research and development of superconductor power generators, research of total systems, research and development of freezing systems, and verification tests; 1999 nendo chodendo denryoku oyo gijutsu kaihatsu seika hokokusho. 1. Chodendo senzai no kenkyu kaihatsu / chodendo hatsudenki no kenkyu kaihatsu / total system no kenkyu / reito system no kenkyu kaihatsu / jissho shiken

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2000-03-01

    With an objective to achieve higher efficiency, higher density, and higher stability in power systems, research and development has been performed on superconductor power applied technologies. This paper summarizes the achievements thereof in fiscal 1999. In research and development of the superconductor wire materials, decrease in loss and increase in capacity of the conductors were progressed for the Nb{sub 3}Sn wire material, whereas its mechanical properties and stability were evaluated. In research and development of the superconductor generators, an ultra high speed responding generator was verified of its healthiness in a sudden short circuit test. A linkage test with an operating 77-kV system was performed, wherein verification was given that the superconductor generator can be operated stably against various disturbances. In research and development of the freezing systems, an improved system was structured, which achieved operation of 11,390 hours in a single system as a result of the high reliability of the oil-free structure. In the verification tests, the ultra high speed responding model generator was connect to the freezing system to give such tests as load test, onerous test, actuation test by using the M-G system, and 77-kV system linkage test. The functions, reliability, and durability of the system were verified, and different data were acquired. (NEDO)

  4. A Practitioners Perspective on Verification

    Science.gov (United States)

    Steenburgh, R. A.

    2017-12-01

    NOAAs Space Weather Prediction Center offers a wide range of products and services to meet the needs of an equally wide range of customers. A robust verification program is essential to the informed use of model guidance and other tools by both forecasters and end users alike. In this talk, we present current SWPC practices and results, and examine emerging requirements and potential approaches to satisfy them. We explore the varying verification needs of forecasters and end users, as well as the role of subjective and objective verification. Finally, we describe a vehicle used in the meteorological community to unify approaches to model verification and facilitate intercomparison.

  5. Clinical trial registries: a practical guide for sponsors and researchers of medicinal products

    National Research Council Canada - National Science Library

    Foote, MaryAnn

    2006-01-01

    ... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ix MaryAnn Foote Clinical trial registries and publication of results - a primer . . . . . . . . . . . . . . . . . . 1 Ana Marušić and Charlotte Haug The journal...

  6. EULAR recommendations for the treatment of systemic sclerosis: a report from the EULAR Scleroderma Trials and Research group (EUSTAR)

    NARCIS (Netherlands)

    Kowal-Bielecka, O.; Landewé, R.; Avouac, J.; Chwiesko, S.; Miniati, I.; Czirjak, L.; Clements, P.; Denton, C.; Farge, D.; Fligelstone, K.; Földvari, I.; Furst, D. E.; Müller-Ladner, U.; Seibold, J.; Silver, R. M.; Takehara, K.; Toth, B. Garay; Tyndall, A.; Valentini, G.; van den Hoogen, F.; Wigley, F.; Zulian, F.; Matucci-Cerinic, Marco

    2009-01-01

    The optimal treatment of systemic sclerosis (SSc) is a challenge because the pathogenesis of SSc is unclear and it is an uncommon and clinically heterogeneous disease affecting multiple organ systems. The aim of the European League Against Rheumatism (EULAR) Scleroderma Trials and Research group

  7. Changes in clinical trials methodology over time: a systematic review of six decades of research in psychopharmacology.

    Science.gov (United States)

    Brunoni, André R; Tadini, Laura; Fregni, Felipe

    2010-03-03

    There have been many changes in clinical trials methodology since the introduction of lithium and the beginning of the modern era of psychopharmacology in 1949. The nature and importance of these changes have not been fully addressed to date. As methodological flaws in trials can lead to false-negative or false-positive results, the objective of our study was to evaluate the impact of methodological changes in psychopharmacology clinical research over the past 60 years. We performed a systematic review from 1949 to 2009 on MEDLINE and Web of Science electronic databases, and a hand search of high impact journals on studies of seven major drugs (chlorpromazine, clozapine, risperidone, lithium, fluoxetine and lamotrigine). All controlled studies published 100 months after the first trial were included. Ninety-one studies met our inclusion criteria. We analyzed the major changes in abstract reporting, study design, participants' assessment and enrollment, methodology and statistical analysis. Our results showed that the methodology of psychiatric clinical trials changed substantially, with quality gains in abstract reporting, results reporting, and statistical methodology. Recent trials use more informed consent, periods of washout, intention-to-treat approach and parametric tests. Placebo use remains high and unchanged over time. Clinical trial quality of psychopharmacological studies has changed significantly in most of the aspects we analyzed. There was significant improvement in quality reporting and internal validity. These changes have increased study efficiency; however, there is room for improvement in some aspects such as rating scales, diagnostic criteria and better trial reporting. Therefore, despite the advancements observed, there are still several areas that can be improved in psychopharmacology clinical trials.

  8. Changes in clinical trials methodology over time: a systematic review of six decades of research in psychopharmacology.

    Directory of Open Access Journals (Sweden)

    André R Brunoni

    2010-03-01

    Full Text Available There have been many changes in clinical trials methodology since the introduction of lithium and the beginning of the modern era of psychopharmacology in 1949. The nature and importance of these changes have not been fully addressed to date. As methodological flaws in trials can lead to false-negative or false-positive results, the objective of our study was to evaluate the impact of methodological changes in psychopharmacology clinical research over the past 60 years.We performed a systematic review from 1949 to 2009 on MEDLINE and Web of Science electronic databases, and a hand search of high impact journals on studies of seven major drugs (chlorpromazine, clozapine, risperidone, lithium, fluoxetine and lamotrigine. All controlled studies published 100 months after the first trial were included. Ninety-one studies met our inclusion criteria. We analyzed the major changes in abstract reporting, study design, participants' assessment and enrollment, methodology and statistical analysis. Our results showed that the methodology of psychiatric clinical trials changed substantially, with quality gains in abstract reporting, results reporting, and statistical methodology. Recent trials use more informed consent, periods of washout, intention-to-treat approach and parametric tests. Placebo use remains high and unchanged over time.Clinical trial quality of psychopharmacological studies has changed significantly in most of the aspects we analyzed. There was significant improvement in quality reporting and internal validity. These changes have increased study efficiency; however, there is room for improvement in some aspects such as rating scales, diagnostic criteria and better trial reporting. Therefore, despite the advancements observed, there are still several areas that can be improved in psychopharmacology clinical trials.

  9. Clinical Trials

    Medline Plus

    Full Text Available ... medical knowledge and practice. Why Clinical Trials Are Important Clinical trials are a key research tool for ... other for moderate persistent asthma. The results provided important treatment information for doctors and patients. The results ...

  10. Clinical Trials

    Medline Plus

    Full Text Available ... Working at the NHLBI Contact and FAQs Accessible Search Form Search the NHLBI, use the drop down list to ... to learn more about clinical research and to search for clinical trials: NHLBI Clinical Trials Browse a ...

  11. Clinical Trials

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    Full Text Available ... to main content U.S. Department of Health & Human ... of people. Clinical trials produce the best data available for health care decisionmaking. The purpose of clinical trials is research, ...

  12. Clinical Trials

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    Full Text Available ... risks that outweigh any possible benefits. Clinical Trial Phases Clinical trials of new medicines or medical devices are done in phases. These phases have different purposes and help researchers ...

  13. Clinical Trials

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    Full Text Available ... the past, clinical trial participants often were White men. Researchers assumed that trial results were valid for ... different ethnic groups sometimes respond differently than White men to the same medical approach. As a result, ...

  14. Clinical Trials

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    Full Text Available ... comparison groups by chance, rather than choice. This method helps ensure that any differences observed during a ... to learn more about clinical research and to search for clinical trials: NHLBI Clinical Trials Browse a ...

  15. Clinical Trials

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    Full Text Available ... Clinical trials produce the best data available for health care decisionmaking. The purpose of clinical trials is research, ... and advance medical care. They also can help health care decisionmakers direct resources to the strategies and treatments ...

  16. Clinical Trials

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    Full Text Available ... whether a new approach causes any harm. In later phases of clinical trials, researchers learn more about ... other National Institutes of Health (NIH) Institutes and Centers sponsor clinical trials. Many other groups, companies, and ...

  17. Clinical Trials

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    Full Text Available ... are research studies that explore whether a medical strategy, treatment, or device is safe and effective for ... a Clinical Trial If you're interested in learning more about, or taking part in, clinical trials, ...

  18. Clinical Trials

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    Full Text Available ... trials produce the best data available for health care decisionmaking. The purpose of clinical trials is research, ... they advance medical knowledge and help improve patient care. Sponsorship and Funding The National Heart, Lung, and ...

  19. Clinical Trials

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    Full Text Available ... medical knowledge and practice. Why Clinical Trials Are Important Clinical trials are a key research tool for ... and Usage No FEAR Act Grants and Funding Customer Service/Center for Health Information Email Alerts Jobs ...

  20. High-level verification

    CERN Document Server

    Lerner, Sorin; Kundu, Sudipta

    2011-01-01

    Given the growing size and heterogeneity of Systems on Chip (SOC), the design process from initial specification to chip fabrication has become increasingly complex. This growing complexity provides incentive for designers to use high-level languages such as C, SystemC, and SystemVerilog for system-level design. While a major goal of these high-level languages is to enable verification at a higher level of abstraction, allowing early exploration of system-level designs, the focus so far for validation purposes has been on traditional testing techniques such as random testing and scenario-based

  1. Cellular Therapies Clinical Research Roadmap: lessons learned on how to move a cellular therapy into a clinical trial.

    Science.gov (United States)

    Ouseph, Stacy; Tappitake, Darah; Armant, Myriam; Wesselschmidt, Robin; Derecho, Ivy; Draxler, Rebecca; Wood, Deborah; Centanni, John M

    2015-04-01

    A clinical research roadmap has been developed as a resource for researchers to identify critical areas and potential pitfalls when transitioning a cellular therapy product from the research laboratory, by means of an Investigational New Drug (IND) application, into early-phase clinical trials. The roadmap describes four key areas: basic and preclinical research, resource development, translational research and Good Manufacturing Practice (GMP) and IND assembly and submission. Basic and preclinical research identifies a new therapeutic concept and demonstrates its potential value with the use of a model of the relevant disease. During resource development, the appropriate specialists and the required expertise to bring this product into the clinic are identified (eg, researchers, regulatory specialists, GMP manufacturing staff, clinicians and clinical trials staff, etc). Additionally, the funds required to achieve this goal (or a plan to procure them) are identified. In the next phase, the plan to translate the research product into a clinical-grade therapeutic is developed. Finally regulatory approval to start the trial must be obtained. In the United States, this is done by filing an IND application with the Food and Drug Administration. The National Heart, Lung and Blood Institute-funded Production Assistance for Cellular Therapies program has facilitated the transition of a variety of cellular therapy products from the laboratory into Phase1/2 trials. The five Production Assistance for Cellular Therapies facilities have assisted investigators by performing translational studies and GMP manufacturing to ensure that cellular products met release specifications and were manufactured safely, reproducibly and at the appropriate scale. The roadmap resulting from this experience is the focus of this article. Copyright © 2015 International Society for Cellular Therapy. Published by Elsevier Inc. All rights reserved.

  2. Nailfold capillaroscopy in systemic sclerosis: data from the EULAR scleroderma trials and research (EUSTAR) database.

    Science.gov (United States)

    Ingegnoli, Francesca; Ardoino, Ilaria; Boracchi, Patrizia; Cutolo, Maurizio

    2013-09-01

    The aims of this study were to obtain cross-sectional data on capillaroscopy in an international multi-center cohort of Systemic Sclerosis (SSc) and to investigate the frequency of the capillaroscopic patterns and their disease-phenotype associations. Data collected between June 2004 and October 2011 in the EULAR Scleroderma Trials and Research (EUSTAR) registry were examined. Patients' profiles based on clinical and laboratory data were obtained by cluster analysis and the association between profiles and capillaroscopy was investigated by multinomial logistic regression. 62 of the 110 EUSTAR centers entered data on capillaroscopy in the EUSTAR database. 376 of the 2754 patients (13.65%) were classified as scleroderma pattern absent, but non-specific capillary abnormalities were noted in 55.48% of the cases. Four major patients' profiles were identified characterized by a progressive severity for skin involvement, as well as an increased number of systemic manifestations. The "early" and "active" scleroderma patterns were generally observed in patients with mild/moderate skin involvement and a low number of disease manifestations, while the "late" scleroderma pattern was found more frequently in the more severe forms of the disease. These data indicate the importance of capillaroscopy in SSc management and that capillaroscopic patterns are directly related to the extent of organ involvement. Copyright © 2013 Elsevier Inc. All rights reserved.

  3. Research designs for proof-of-concept chronic pain clinical trials

    DEFF Research Database (Denmark)

    Gewandter, Jennifer S; Dworkin, Robert H; Turk, Dennis C

    2014-01-01

    Proof-of-concept (POC) clinical trials play an important role in developing novel treatments and determining whether existing treatments may be efficacious in broader populations of patients. The goal of most POC trials is to determine whether a treatment is likely to be efficacious for a given i...

  4. Survey on Offline Finger Print Verification System

    NARCIS (Netherlands)

    Suman, R.; Kaur, R.

    2012-01-01

    The fingerprint verification, means where "verification" implies a user matching a fingerprint against a single fingerprint associated with the identity that the user claims. Biometrics can be classified into two types Behavioral (signature verification, keystroke dynamics, etc.) And Physiological

  5. HIV vaccine research--South Africa's ethical-legal framework and its ability to promote the welfare of trial participants.

    Science.gov (United States)

    Strode, Ann; Slack, Catherine; Mushariwa, Muriel

    2005-08-01

    An effective ethical-legal framework for the conduct of research is critical. We describe five essential components of such a system, review the extent to which these components have been realised in South Africa, present brief implications for the ethical conduct of clinical trials of HIV vaccines in South Africa and make recommendations. The components of an effective ethical-legal system that we propose are the existence of scientific ethical and policy-making structures that regulate research; research ethics committees (RECs) that ethically review research; national ethical guidelines and standards; laws protecting research participants; and mechanisms to enforce and monitor legal rights and ethical standards. We conclude that the ethical-legal framework has, for the most part, the necessary institutions, and certain necessary guidelines but does not have many of the laws needed to protect and promote the rights of persons participating in research, including HIV vaccine trials. Recommendations made include advocacy measures to finalise and implement legislation, development of regulations, analysis and comparison of ethical guidelines, and the development of measures to monitor ethical-legal rights at trial sites.

  6. Influences on recruitment to randomised controlled trials in mental health settings in England: a national cross-sectional survey of researchers working for the Mental Health Research Network.

    Science.gov (United States)

    Borschmann, Rohan; Patterson, Sue; Poovendran, Dilkushi; Wilson, Danielle; Weaver, Tim

    2014-02-17

    Recruitment to trials is complex and often protracted; selection bias may compromise generalisability. In the mental health field (as elsewhere), diverse factors have been described as hindering researcher access to potential participants and various strategies have been proposed to overcome barriers. However, the extent to which various influences identified in the literature are operational across mental health settings in England has not been systematically examined. A cross-sectional, online survey of clinical studies officers employed by the Mental Health Research Network in England to recruit to trials from National Health Service mental health services. The bespoke questionnaire invited participants to report exposure to specified influences on recruitment, the perceived impact of these on access to potential participants, and to describe additional positive or negative influences on recruitment. Analysis employed descriptive statistics, the framework approach and triangulation of data. Questionnaires were returned by 98 (58%) of 170 clinical studies officers who reported diverse experience. Data demonstrated a disjunction between policy and practice. While the particulars of trial design and various marketing and communication strategies could influence recruitment, consensus was that the culture of NHS mental health services is not conducive to research. Since financial rewards for recruitment paid to Trusts and feedback about studies seldom reaching frontline services, clinicians were described as distanced from research. Facing continual service change and demanding clinical workloads, clinicians generally did not prioritise recruitment activities. Incentives to trial participants had variable impact on access but recruitment could be enhanced by engagement of senior investigators and integrating referral with routine practice. Comprehensive, robust feasibility studies and reciprocity between researchers and clinicians were considered crucial to

  7. Characterization of radioactive contaminants and water treatment trials for the Taiwan Research Reactor's spent fuel pool

    International Nuclear Information System (INIS)

    Huang, Chun-Ping; Lin, Tzung-Yi; Chiao, Ling-Huan; Chen, Hong-Bin

    2012-01-01

    Highlights: ► Deal with a practical radioactive contamination in Taiwan Research Reactor spent fuel pool water. ► Identify the properties of radioactive contaminants and performance test for water treatment materials. ► The radioactive solids were primary attributed by ruptured spent fuels, spent resins, and metal debris. ► The radioactive ions were major composed by uranium and fission products. ► Diatomite-based ceramic depth filter can simultaneously removal radioactive solids and ions. - Abstract: There were approximately 926 m 3 of water contaminated by fission products and actinides in the Taiwan Research Reactor's spent fuel pool (TRR SFP). The solid and ionic contaminants were thoroughly characterized using radiochemical analyses, scanning electron microscopy equipped with an energy dispersive spectrometer (SEM-EDS), and inductively coupled plasma optical emission spectrometry (ICP-OES) in this study. The sludge was made up of agglomerates contaminated by spent fuel particles. Suspended solids from spent ion-exchange resins interfered with the clarity of the water. In addition, the ionic radionuclides such as 137 Cs, 90 Sr, U, and α-emitters, present in the water were measured. Various filters and cation-exchange resins were employed for water treatment trials, and the results indicated that the solid and ionic contaminants could be effectively removed through the use of <0.9 μm filters and cation exchange resins, respectively. Interestingly, the removal of U was obviously efficient by cation exchange resin, and the ceramic depth filter composed of diatomite exhibited the properties of both filtration and adsorption. It was found that the ceramic depth filter could adsorb β-emitters, α-emitters, and uranium ions. The diatomite-based ceramic depth filter was able to simultaneously eliminate particles and adsorb ionic radionuclides from water.

  8. Functions of social support and self-verification in association with loneliness, depression, and stress.

    Science.gov (United States)

    Wright, Kevin B; King, Shawn; Rosenberg, Jenny

    2014-01-01

    This study investigated the influence of social support and self-verification on loneliness, depression, and stress among 477 college students. The authors propose and test a theoretical model using structural equation modeling. The results indicated empirical support for the model, with self-verification mediating the relation between social support and health outcomes. The results have implications for social support and self-verification research, which are discussed along with directions for future research and limitations of the study.

  9. The Development of a Communication Tool to Facilitate the Cancer Trial Recruitment Process and Increase Research Literacy among Underrepresented Populations.

    Science.gov (United States)

    Torres, Samantha; de la Riva, Erika E; Tom, Laura S; Clayman, Marla L; Taylor, Chirisse; Dong, Xinqi; Simon, Melissa A

    2015-12-01

    Despite increasing need to boost the recruitment of underrepresented populations into cancer trials and biobanking research, few tools exist for facilitating dialogue between researchers and potential research participants during the recruitment process. In this paper, we describe the initial processes of a user-centered design cycle to develop a standardized research communication tool prototype for enhancing research literacy among individuals from underrepresented populations considering enrollment in cancer research and biobanking studies. We present qualitative feedback and recommendations on the prototype's design and content from potential end users: five clinical trial recruiters and ten potential research participants recruited from an academic medical center. Participants were given the prototype (a set of laminated cards) and were asked to provide feedback about the tool's content, design elements, and word choices during semi-structured, in-person interviews. Results suggest that the prototype was well received by recruiters and patients alike. They favored the simplicity, lay language, and layout of the cards. They also noted areas for improvement, leading to card refinements that included the following: addressing additional topic areas, clarifying research processes, increasing the number of diverse images, and using alternative word choices. Our process for refining user interfaces and iterating content in early phases of design may inform future efforts to develop tools for use in clinical research or biobanking studies to increase research literacy.

  10. Assessing Clinical Research Capacity in Vietnam: A Framework for Strengthening Capability for Clinical Trials in Developing Countries.

    Science.gov (United States)

    Kagan, Jonathan; Giang, Dao Duc; Iademarco, Michael F; Phung, Van Tt; Lau, Chuen-Yen; Quang, Nguyen Ngo

    2016-01-01

    Although improving health systems promises important benefits, most developing nations lack the resources to support nationally driven clinical research. Strengthened clinical research capacity can advance national health goals by supporting greater autonomy in aligning research with national priorities. From March through June 2010, we assessed six elements of clinical research capacity in Vietnam: research agenda; clinical investigators and biostatisticians; donors and sponsors; community involvement; scientific, ethical, safety, and quality oversight; and clinical research institutions. Assessments were drawn from interviews with investigators, Ministry of Health staff members, nongovernment organizations, and U.S. Mission staff members, and document review. Observations and recommendations were shared with collaborators. Reassessment in 2015 found growth in the number of clinical trials, improved regulation in human subjects protection and community engagement, and modest advances in research agenda setting. Training and investment in institutions remain challenging. A framework for assessing clinical research capacity can affirm strengths and weaknesses and guide the coordination of capacity-building efforts.

  11. An assessment of radioactivity level in 51Cr-contaminated dry solid waste generated from a research facility for verification of clearance levels

    International Nuclear Information System (INIS)

    Nagamatsu, Tomohiro; Yamaoka, Kiyonori; Hanafusa, Tadashi; Ono, Toshiro

    2010-01-01

    Radioactive waste generated from research laboratories and other facilities is regulated by the Law Concerning Prevention from Radiation Hazards due to Radioisotopes etc. (Prevention Law). However, the Prevention Law does not provide the level of clearance or the procedures to follow for compliance monitoring. To assess radioactivity amounts for making decisions about clearance levels, the radioactivity levels in dry solid semi-combustible wastes generated from biomedical research, such as 51 Cr-release assays, were measured and evaluated. Radioactivity of semi-combustible waste was 1.42-6.32% of the initial level. In comparison, records for the past 8 years in the Shikata Laboratory, Department of Radiation Research, Okayama University Advanced Science Research Center, indicated 7% to 90% of the initial radioactivity remained in the waste and was differed widely among researchers. This study determined an accurate radioactivity level in dry solid waste, which could lead to savings in disposal costs. (author)

  12. Safety Verification for Probabilistic Hybrid Systems

    Czech Academy of Sciences Publication Activity Database

    Zhang, J.; She, Z.; Ratschan, Stefan; Hermanns, H.; Hahn, E.M.

    2012-01-01

    Roč. 18, č. 6 (2012), s. 572-587 ISSN 0947-3580 R&D Projects: GA MŠk OC10048; GA ČR GC201/08/J020 Institutional research plan: CEZ:AV0Z10300504 Keywords : model checking * hybrid system s * formal verification Subject RIV: IN - Informatics, Computer Science Impact factor: 1.250, year: 2012

  13. Using Mechanical Turk to recruit participants for internet intervention research: experience from recruitment for four trials targeting hazardous alcohol consumption

    Directory of Open Access Journals (Sweden)

    John A. Cunningham

    2017-12-01

    Full Text Available Abstract Background Mechanical Turk (MTurk is an online portal operated by Amazon where ‘requesters’ (individuals or businesses can submit jobs for ‘workers.’ MTurk is used extensively by academics as a quick and cheap means of collecting questionnaire data, including information on alcohol consumption, from a diverse sample of participants. We tested the feasibility of recruiting for alcohol Internet intervention trials through MTurk. Methods Participants, 18 years or older, who drank at least weekly were recruited for four intervention trials (combined sample size, N = 11,107. The same basic recruitment strategy was employed for each trial – invite participants to complete a survey about alcohol consumption (less than 15 min in length, US$1.50 payment, identify eligible participants who drank in a hazardous fashion, invite those eligible to complete a follow-up survey ($10 payment, randomize participants to be sent or not sent information to access an online intervention for hazardous alcohol use. Procedures where put in place to optimize the chances that participants could only complete the baseline survey once. Results There was a substantially slower rate of recruitment by the fourth trial compared to the earlier trials. Demographic characteristics also varied across trials (age, sex, employment and marital status. Patterns of alcohol consumption, while displaying some differences, did not appear to vary in a linear fashion between trials. Conclusions It is possible to recruit large (but not inexhaustible numbers of people who drink in a hazardous fashion. Issues for online intervention research when employing this sample are discussed.

  14. Patient and Family Engagement in Designing and Implementing a Weaning Trial: A Novel Research Paradigm in Critical Care.

    Science.gov (United States)

    Burns, Karen E A; Devlin, John W; Hill, Nicholas S

    2017-10-01

    The call for meaningful patient and family engagement in research has recently gained considerable momentum. This article defines patient and family engagement broadly and specifically in clinical research. Using a multicenter, North American weaning trial as an exemplar, we describe our early experiences as clinical researchers with patient and family engagement. The role of our Patient and Family Advisory Committee in trial design and implementation is illustrated. Through our experiences, we share our insights regarding the perceived opportunities and also highlight some challenges associated with engaging patients and family engagement in critical care research. Although "engagement science" is in its infancy, engaging patients and families in research holds promise as a novel research paradigm that will not only provide new insights into the questions, methods, and outcomes used in ICU research, but it will also make investments in research more accountable and ensure a strong "patient- and family-centered focus" of our research. Copyright © 2017 American College of Chest Physicians. Published by Elsevier Inc. All rights reserved.

  15. Brain Research to Ameliorate Impaired Neurodevelopment - Home-based Intervention Trial (BRAIN-HIT

    Directory of Open Access Journals (Sweden)

    Mahantshetti Niranjana S

    2010-04-01

    Full Text Available Abstract Background This randomized controlled trial aims to evaluate the effects of an early developmental intervention program on the development of young children in low- and low-middle-income countries who are at risk for neurodevelopmental disability because of birth asphyxia. A group of children without perinatal complications are evaluated in the same protocol to compare the effects of early developmental intervention in healthy infants in the same communities. Birth asphyxia is the leading specific cause of neonatal mortality in low- and low-middle-income countries and is also the main cause of neonatal and long-term morbidity including mental retardation, cerebral palsy, and other neurodevelopmental disorders. Mortality and morbidity from birth asphyxia disproportionately affect more infants in low- and low-middle-income countries, particularly those from the lowest socioeconomic groups. There is evidence that relatively inexpensive programs of early developmental intervention, delivered during home visit by parent trainers, are capable of improving neurodevelopment in infants following brain insult due to birth asphyxia. Methods/Design This trial is a block-randomized controlled trial that has enrolled 174 children with birth asphyxia and 257 without perinatal complications, comparing early developmental intervention plus health and safety counseling to the control intervention receiving health and safety counseling only, in sites in India, Pakistan, and Zambia. The interventions are delivered in home visits every two weeks by parent trainers from 2 weeks after birth until age 36 months. The primary outcome of the trial is cognitive development, and secondary outcomes include social-emotional and motor development. Child, parent, and family characteristics and number of home visits completed are evaluated as moderating factors. Discussion The trial is supervised by a trial steering committee, and an independent data monitoring

  16. A Systematic Review of Community-Based Participatory Research to Enhance Clinical Trials in Racial and Ethnic Minority Groups

    Science.gov (United States)

    De Las Nueces, Denise; Hacker, Karen; DiGirolamo, Ann; Hicks, LeRoi S

    2012-01-01

    Objective To examine the effectiveness of current community-based participatory research (CBPR) clinical trials involving racial and ethnic minorities. Data Source All published peer-reviewed CBPR intervention articles in PubMed and CINAHL databases from January 2003 to May 2010. Study Design We performed a systematic literature review. Data Collection/Extraction Methods Data were extracted on each study's characteristics, community involvement in research, subject recruitment and retention, and intervention effects. Principle Findings We found 19 articles meeting inclusion criteria. Of these, 14 were published from 2007 to 2010. Articles described some measures of community participation in research with great variability. Although CBPR trials examined a wide range of behavioral and clinical outcomes, such trials had very high success rates in recruiting and retaining minority participants and achieving significant intervention effects. Conclusions Significant publication gaps remain between CBPR and other interventional research methods. CBPR may be effective in increasing participation of racial and ethnic minority subjects in research and may be a powerful tool in testing the generalizability of effective interventions among these populations. CBPR holds promise as an approach that may contribute greatly to the study of health care delivery to disadvantaged populations. PMID:22353031

  17. Cost-effectiveness analysis alongside clinical trials II-An ISPOR Good Research Practices Task Force report.

    Science.gov (United States)

    Ramsey, Scott D; Willke, Richard J; Glick, Henry; Reed, Shelby D; Augustovski, Federico; Jonsson, Bengt; Briggs, Andrew; Sullivan, Sean D

    2015-03-01

    Clinical trials evaluating medicines, medical devices, and procedures now commonly assess the economic value of these interventions. The growing number of prospective clinical/economic trials reflects both widespread interest in economic information for new technologies and the regulatory and reimbursement requirements of many countries that now consider evidence of economic value along with clinical efficacy. As decision makers increasingly demand evidence of economic value for health care interventions, conducting high-quality economic analyses alongside clinical studies is desirable because they broaden the scope of information available on a particular intervention, and can efficiently provide timely information with high internal and, when designed and analyzed properly, reasonable external validity. In 2005, ISPOR published the Good Research Practices for Cost-Effectiveness Analysis Alongside Clinical Trials: The ISPOR RCT-CEA Task Force report. ISPOR initiated an update of the report in 2014 to include the methodological developments over the last 9 years. This report provides updated recommendations reflecting advances in several areas related to trial design, selecting data elements, database design and management, analysis, and reporting of results. Task force members note that trials should be designed to evaluate effectiveness (rather than efficacy) when possible, should include clinical outcome measures, and should obtain health resource use and health state utilities directly from study subjects. Collection of economic data should be fully integrated into the study. An incremental analysis should be conducted with an intention-to-treat approach, complemented by relevant subgroup analyses. Uncertainty should be characterized. Articles should adhere to established standards for reporting results of cost-effectiveness analyses. Economic studies alongside trials are complementary to other evaluations (e.g., modeling studies) as information for decision

  18. Development of outcome measures for large-vessel vasculitis for use in clinical trials: opportunities, challenges, and research agenda.

    Science.gov (United States)

    Direskeneli, Haner; Aydin, Sibel Z; Kermani, Tanaz A; Matteson, Eric L; Boers, Maarten; Herlyn, Karen; Luqmani, Raashid A; Neogi, Tuhina; Seo, Philip; Suppiah, Ravi; Tomasson, Gunnar; Merkel, Peter A

    2011-07-01

    Giant cell (GCA) and Takayasu's arteritis (TAK) are 2 forms of large-vessel vasculitis (LVV) that involve the aorta and its major branches. GCA has a predilection for the cranial branches, while TAK tends to affect the extracranial branches. Both disorders may also cause nonspecific constitutional symptoms. Although some clinical features are more common in one or the other disorder and the ages of initial presentation differ substantially, there is enough clinical and histopathologic overlap between these disorders that some investigators suggest GCA and TAK may be 2 processes within the spectrum of a single disease. There have been few randomized therapeutic trials completed in GCA, and none in TAK. The lack of therapeutic trials in LVV is only partially explained by the rarity of these diseases. It is likely that the lack of well validated outcome measures for LVV and uncertainties regarding trial design contribute to the paucity of trials for these diseases. An initiative to develop a core set of outcome measures for use in clinical trials of LVV was launched by the international OMERACT Vasculitis Working Group in 2009 and subsequently endorsed by the OMERACT community at the OMERACT 10 meeting. Aims of this initiative include: (1) to review the literature and existing data related to outcome assessments in LVV; (2) to obtain the opinion of experts and patients on disease content; and (3) to formulate a research agenda to facilitate a more data-based approach to outcomes development.

  19. Exercise and manual physiotherapy arthritis research trial (EMPART) for osteoarthritis of the hip: a multicenter randomized controlled trial.

    Science.gov (United States)

    French, Helen P; Cusack, Tara; Brennan, Aisling; Caffrey, Aoife; Conroy, Ronán; Cuddy, Vanessa; FitzGerald, Oliver M; Fitzpatrick, Martina; Gilsenan, Clare; Kane, David; O'Connell, Paul G; White, Breon; McCarthy, Geraldine M

    2013-02-01

    To determine the effectiveness of exercise therapy (ET) compared with ET with adjunctive manual therapy (MT) for people with hip osteoarthritis (OA); and to identify if immediate commencement of treatment (ET or ET+MT) was more beneficial than a 9-week waiting period for either intervention. Assessor-blind randomized controlled trial with a 9-week and 18-week follow-up. Four academic teaching hospitals in Dublin, Ireland. Patients (N=131) with hip OA recruited from general practitioners, rheumatologists, orthopedic surgeons, and other hospital consultants were randomized to 1 of 3 groups: ET (n=45), ET+MT (n=43), and waitlist controls (n=43). Participants in both the ET and ET+MT groups received up to 8 treatments over 8 weeks. Control group participants were rerandomized into either ET or ET+MT groups after 9 week follow-up. Their data were pooled with original treatment group data: ET (n=66) and ET+MT (n=65). The primary outcome was the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) physical function (PF) subscale. Secondary outcomes included physical performance, pain severity, hip range of motion (ROM), anxiety/depression, quality of life, medication usage, patient-perceived change, and patient satisfaction. There was no significant difference in WOMAC PF between the ET (n=66) and ET+MT (n=65) groups at 9 weeks (mean difference, .09; 95% confidence interval [CI] -2.93 to 3.11) or 18 weeks (mean difference, .42; 95% CI, -4.41 to 5.25), or between other outcomes, except patient satisfaction with outcomes, which was higher in the ET+MT group (P=.02). Improvements in WOMAC, hip ROM, and patient-perceived change occurred in both treatment groups compared with the control group. Self-reported function, hip ROM, and patient-perceived improvement occurred after an 8-week program of ET for patients with OA of the hip. MT as an adjunct to exercise provided no further benefit, except for higher patient satisfaction with outcome. Copyright © 2013

  20. Exercise and Manual therapy Arthritis Research Trial (EMPART) for osteoarthritis of the hip: A Multicentre Randomised Controlled trial.

    LENUS (Irish Health Repository)

    French, Helen P

    2012-10-16

    OBJECTIVE: To determine the effectiveness of exercise therapy (ET) compared to ET with adjunctive manual therapy (ET+MT) for people with hip osteoarthritis (OA). A secondary aim was to identify if immediate commencement of ET or ET+MT was more beneficial than a 9 week waiting period for either intervention. DESIGN: Assessor-blind randomised controlled trial with 9 and 18 week follow-ups. SETTING: Four academic teaching hospitals, Dublin, Ireland. PARTICIPANTS: 131 patients with hip OA recruited from general practitioners, rheumatologists, orthopaedic surgeons, and other hospital consultants were randomised to one of three groups: ET (n=45), ET+MT (n=43) and wait-list control (n=43). INTERVENTIONS: Participants in both ET and ET+ MT groups received up to 8 treatments over 8 weeks. Control group participants were re-randomised into either ET or ET+MT group after 9 week follow-up. Their data were pooled with original treatment group data: ET (n=66) and ET+MT (n=65). MAIN OUTCOME MEASURES: The primary outcome was the WOMAC physical function (PF) subscale. Secondary outcomes included physical performance, pain, hip range of motion (HROM), anxiety\\/depression, quality of life, medication usage, patient-perceived change and patient satisfaction. RESULTS: There was no significant difference in WOMAC PF between ET (n=66) and ET+MT (n=65) groups at 9 weeks (mean diff 0.09 (95% CI -4.41, 5.25)) or at 18 weeks (mean diff 0.42 (95% CI -3.98, 6.83)), or other outcomes, except \\'patient satisfaction with outcome\\' which was higher in the ET+MT group (p=0.02). Improvements in WOMAC, HROM and patient-perceived change occurred in both treatment groups compared with the control group. CONCLUSION: Self-reported function, HROM and patient-perceived improvement occurred after an 8 week programme of ET for patients with hip OA MT as an adjunct provided no further benefit, except for higher patient satisfaction.

  1. Systematic Review of Integrative Health Care Research: Randomized Control Trials, Clinical Controlled Trials, and Meta-Analysis

    OpenAIRE

    Khorsan, Raheleh; Coulter, Ian D.; Crawford, Cindy; Hsiao, An-Fu

    2010-01-01

    A systematic review was conducted to assess the level of evidence for integrative health care research. We searched PubMed, Allied and Complementary Medicine (AMED), BIOSIS Previews, EMBASE, the entire Cochrane Library, MANTIS, Social SciSearch, SciSearch Cited Ref Sci, PsychInfo, CINAHL, and NCCAM grantee publications listings, from database inception to May 2009, as well as searches of the “gray literature.” Available studies published in English language were included. Three independent re...

  2. Building research in diet and cognition: The BRIDGE randomized controlled trial.

    Science.gov (United States)

    Tussing-Humphreys, Lisa; Lamar, Melissa; Blumenthal, James A; Babyak, Michael; Fantuzzi, Giamila; Blumstein, Lara; Schiffer, Linda; Fitzgibbon, Marian L

    2017-08-01

    Obesity has been linked to cognitive impairment, cognitive decline and dementia. Given that 38.5% of U.S. adults 60years and older are obese and these numbers are rapidly increasing, strategies to decouple obesity from cognitive decline are needed. Innovative lifestyle strategies that may postpone the onset of subclinical symptoms or even arrest the transition to overt dementia in at-risk individuals are critically needed. Poor diet is central to the development of obesity and diet may affect cognition. Adherence to a Mediterranean Diet (MedDiet) is associated with reduced risk of cognitive impairment and dementia. Furthermore, weight loss through caloric restriction improves cognitive function. This paper describes the Building Research in Diet and CoGnition (BRIDGE) study, a randomized trial examining the effect of the MedDiet, with and without weight loss, on cognitive functioning in obese older adults. Obese (BMI≥30 and ≤50kg/m 2 ) older adults (≥55years) (n=180) will be randomized in a 2:2:1 allocation scheme to: Typical Diet Control; MedDiet alone, without weight loss; or MedDiet lifestyle intervention to promote weight loss and weight loss maintenance. Both MedDiet intervention groups will meet for one individual session and 27 group sessions over an 8-month period. Individuals in the control group will not receive instruction on changing lifestyle habits. Outcomes will be assessed at baseline, 8 and 14months. The primary outcome is cognitive functioning; secondary outcomes will include changes in body weight, diet, cardiovascular, metabolic, and inflammatory biomarkers. Copyright © 2017. Published by Elsevier Inc.

  3. Nonparametric estimation for censored mixture data with application to the Cooperative Huntington's Observational Research Trial.

    Science.gov (United States)

    Wang, Yuanjia; Garcia, Tanya P; Ma, Yanyuan

    2012-01-01

    This work presents methods for estimating genotype-specific distributions from genetic epidemiology studies where the event times are subject to right censoring, the genotypes are not directly observed, and the data arise from a mixture of scientifically meaningful subpopulations. Examples of such studies include kin-cohort studies and quantitative trait locus (QTL) studies. Current methods for analyzing censored mixture data include two types of nonparametric maximum likelihood estimators (NPMLEs) which do not make parametric assumptions on the genotype-specific density functions. Although both NPMLEs are commonly used, we show that one is inefficient and the other inconsistent. To overcome these deficiencies, we propose three classes of consistent nonparametric estimators which do not assume parametric density models and are easy to implement. They are based on the inverse probability weighting (IPW), augmented IPW (AIPW), and nonparametric imputation (IMP). The AIPW achieves the efficiency bound without additional modeling assumptions. Extensive simulation experiments demonstrate satisfactory performance of these estimators even when the data are heavily censored. We apply these estimators to the Cooperative Huntington's Observational Research Trial (COHORT), and provide age-specific estimates of the effect of mutation in the Huntington gene on mortality using a sample of family members. The close approximation of the estimated non-carrier survival rates to that of the U.S. population indicates small ascertainment bias in the COHORT family sample. Our analyses underscore an elevated risk of death in Huntington gene mutation carriers compared to non-carriers for a wide age range, and suggest that the mutation equally affects survival rates in both genders. The estimated survival rates are useful in genetic counseling for providing guidelines on interpreting the risk of death associated with a positive genetic testing, and in facilitating future subjects at risk

  4. Verification of Simulation Tools

    International Nuclear Information System (INIS)

    Richard, Thierry

    2015-01-01

    Before qualifying a simulation tool, the requirements shall first be clearly identified, i.e.: - What type of study needs to be carried out? - What phenomena need to be modeled? This phase involves writing a precise technical specification. Once the requirements are defined, the most adapted product shall be selected from the various software options available on the market. Before using a particular version of a simulation tool to support the demonstration of nuclear safety studies, the following requirements shall be met. - An auditable quality assurance process complying with development international standards shall be developed and maintained, - A process of verification and validation (V and V) shall be implemented. This approach requires: writing a report and/or executive summary of the V and V activities, defining a validated domain (domain in which the difference between the results of the tools and those of another qualified reference is considered satisfactory for its intended use). - Sufficient documentation shall be available, - A detailed and formal description of the product (software version number, user configuration, other settings and parameters) in the targeted computing environment shall be available. - Source codes corresponding to the software shall be archived appropriately. When these requirements are fulfilled, the version of the simulation tool shall be considered qualified for a defined domain of validity, in a given computing environment. The functional verification shall ensure that: - the computer architecture of the tool does not include errors, - the numerical solver correctly represents the physical mathematical model, - equations are solved correctly. The functional verification can be demonstrated through certification or report of Quality Assurance. The functional validation shall allow the user to ensure that the equations correctly represent the physical phenomena in the perimeter of intended use. The functional validation can

  5. Brain research to ameliorate impaired neurodevelopment--home-based intervention trial (BRAIN-HIT).

    Science.gov (United States)

    Wallander, Jan L; McClure, Elizabeth; Biasini, Fred; Goudar, Shivaprasad S; Pasha, Omrana; Chomba, Elwyn; Shearer, Darlene; Wright, Linda; Thorsten, Vanessa; Chakraborty, Hrishikesh; Dhaded, Sangappa M; Mahantshetti, Niranjana S; Bellad, Roopa M; Abbasi, Zahid; Carlo, Waldemar

    2010-04-30

    This randomized controlled trial aims to evaluate the effects of an early developmental intervention program on the development of young children in low- and low-middle-income countries who are at risk for neurodevelopmental disability because of birth asphyxia. A group of children without perinatal complications are evaluated in the same protocol to compare the effects of early developmental intervention in healthy infants in the same communities. Birth asphyxia is the leading specific cause of neonatal mortality in low- and low-middle-income countries and is also the main cause of neonatal and long-term morbidity including mental retardation, cerebral palsy, and other neurodevelopmental disorders. Mortality and morbidity from birth asphyxia disproportionately affect more infants in low- and low-middle-income countries, particularly those from the lowest socioeconomic groups. There is evidence that relatively inexpensive programs of early developmental intervention, delivered during home visit by parent trainers, are capable of improving neurodevelopment in infants following brain insult due to birth asphyxia. This trial is a block-randomized controlled trial that has enrolled 174 children with birth asphyxia and 257 without perinatal complications, comparing early developmental intervention plus health and safety counseling to the control intervention receiving health and safety counseling only, in sites in India, Pakistan, and Zambia. The interventions are delivered in home visits every two weeks by parent trainers from 2 weeks after birth until age 36 months. The primary outcome of the trial is cognitive development, and secondary outcomes include social-emotional and motor development. Child, parent, and family characteristics and number of home visits completed are evaluated as moderating factors. The trial is supervised by a trial steering committee, and an independent data monitoring committee monitors the trial. Findings from this trial have the potential

  6. Verification and validation in computational fluid dynamics

    Science.gov (United States)

    Oberkampf, William L.; Trucano, Timothy G.

    2002-04-01

    Verification and validation (V&V) are the primary means to assess accuracy and reliability in computational simulations. This paper presents an extensive review of the literature in V&V in computational fluid dynamics (CFD), discusses methods and procedures for assessing V&V, and develops a number of extensions to existing ideas. The review of the development of V&V terminology and methodology points out the contributions from members of the operations research, statistics, and CFD communities. Fundamental issues in V&V are addressed, such as code verification versus solution verification, model validation versus solution validation, the distinction between error and uncertainty, conceptual sources of error and uncertainty, and the relationship between validation and prediction. The fundamental strategy of verification is the identification and quantification of errors in the computational model and its solution. In verification activities, the accuracy of a computational solution is primarily measured relative to two types of highly accurate solutions: analytical solutions and highly accurate numerical solutions. Methods for determining the accuracy of numerical solutions are presented and the importance of software testing during verification activities is emphasized. The fundamental strategy of validation is to assess how accurately the computational results compare with the experimental data, with quantified error and uncertainty estimates for both. This strategy employs a hierarchical methodology that segregates and simplifies the physical and coupling phenomena involved in the complex engineering system of interest. A hypersonic cruise missile is used as an example of how this hierarchical structure is formulated. The discussion of validation assessment also encompasses a number of other important topics. A set of guidelines is proposed for designing and conducting validation experiments, supported by an explanation of how validation experiments are different

  7. Reconciling research and implementation in micro health insurance experiments in India: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Doyle Conor

    2011-10-01

    Full Text Available Abstract Background Microinsurance or Community-Based Health Insurance is a promising healthcare financing mechanism, which is increasingly applied to aid rural poor persons in low-income countries. Robust empirical evidence on the causal relations between Community-Based Health Insurance and healthcare utilisation, financial protection and other areas is scarce and necessary. This paper contains a discussion of the research design of three Cluster Randomised Controlled Trials in India to measure the impact of Community-Based Health Insurance on several outcomes. Methods/Design Each trial sets up a Community-Based Health Insurance scheme among a group of micro-finance affiliate families. Villages are grouped into clusters which are congruous with pre-existing social groupings. These clusters are randomly assigned to one of three waves of implementation, ensuring the entire population is offered Community-Based Health Insurance by the end of the experiment. Each wave of treatment is preceded by a round of mixed methods evaluation, with quantitative, qualitative and spatial evidence on impact collected. Improving upon practices in published Cluster Randomised Controlled Trial literature, we detail how research design decisions have ensured that both the households offered insurance and the implementers of the Community-Based Health Insurance scheme operate in an environment replicating a non-experimental implementation. Discussion When a Cluster Randomised Controlled Trial involves randomizing within a community, generating adequate and valid conclusions requires that the research design must be made congruous with social structures within the target population, to ensure that such trials are conducted in an implementing environment which is a suitable analogue to that of a non-experimental implementing environment.

  8. Understanding the patient perspective on research access to national health records databases for conduct of randomized registry trials.

    Science.gov (United States)

    Avram, Robert; Marquis-Gravel, Guillaume; Simard, François; Pacheco, Christine; Couture, Étienne; Tremblay-Gravel, Maxime; Desplantie, Olivier; Malhamé, Isabelle; Bibas, Lior; Mansour, Samer; Parent, Marie-Claude; Farand, Paul; Harvey, Luc; Lessard, Marie-Gabrielle; Ly, Hung; Liu, Geoffrey; Hay, Annette E; Marc Jolicoeur, E

    2018-07-01

    Use of health administrative databases is proposed for screening and monitoring of participants in randomized registry trials. However, access to these databases raises privacy concerns. We assessed patient's preferences regarding use of personal information to link their research records with national health databases, as part of a hypothetical randomized registry trial. Cardiology patients were invited to complete an anonymous self-reported survey that ascertained preferences related to the concept of accessing government health databases for research, the type of personal identifiers to be shared and the type of follow-up preferred as participants in a hypothetical trial. A total of 590 responders completed the survey (90% response rate), the majority of which were Caucasians (90.4%), male (70.0%) with a median age of 65years (interquartile range, 8). The majority responders (80.3%) would grant researchers access to health administrative databases for screening and follow-up. To this end, responders endorsed the recording of their personal identifiers by researchers for future record linkage, including their name (90%), and health insurance number (83.9%), but fewer responders agreed with the recording of their social security number (61.4%, pgranting researchers access to the administrative databases (OR: 1.69, 95% confidence interval: 1.03-2.90; p=0.04). The majority of Cardiology patients surveyed were supportive of use of their personal identifiers to access administrative health databases and conduct long-term monitoring in the context of a randomized registry trial. Copyright © 2018 Elsevier Ireland Ltd. All rights reserved.

  9. Clinical Trials

    Medline Plus

    Full Text Available ... clinical trials are required to have an IRB. Office for Human Research Protections The U.S. Department of Health and Human Services’ (HHS’) Office for Human Research Protections (OHRP) oversees all research ...

  10. Systematic Review of Integrative Health Care Research: Randomized Control Trials, Clinical Controlled Trials, and Meta-Analysis

    Directory of Open Access Journals (Sweden)

    Raheleh Khorsan

    2011-01-01

    Full Text Available A systematic review was conducted to assess the level of evidence for integrative health care research. We searched PubMed, Allied and Complementary Medicine (AMED, BIOSIS Previews, EMBASE, the entire Cochrane Library, MANTIS, Social SciSearch, SciSearch Cited Ref Sci, PsychInfo, CINAHL, and NCCAM grantee publications listings, from database inception to May 2009, as well as searches of the “gray literature.” Available studies published in English language were included. Three independent reviewers rated each article and assessed the methodological quality of studies using the Scottish Intercollegiate Guidelines Network (SIGN 50. Our search yielded 11,891 total citations but 6 clinical studies, including 4 randomized, met our inclusion criteria. There are no available systematic reviews/meta-analyses published that met our inclusion criteria. The methodological quality of the included studies was assessed independently using quality checklists of the SIGN 50. Only a small number of RCTs and CCTs with a limited number of patients and lack of adequate control groups assessing integrative health care research are available. These studies provide limited evidence of effective integrative health care on some modalities. However, integrative health care regimen appears to be generally safe.

  11. Shift Verification and Validation

    Energy Technology Data Exchange (ETDEWEB)

    Pandya, Tara M. [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States); Evans, Thomas M. [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States); Davidson, Gregory G [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States); Johnson, Seth R. [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States); Godfrey, Andrew T. [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States)

    2016-09-07

    This documentation outlines the verification and validation of Shift for the Consortium for Advanced Simulation of Light Water Reactors (CASL). Five main types of problems were used for validation: small criticality benchmark problems; full-core reactor benchmarks for light water reactors; fixed-source coupled neutron-photon dosimetry benchmarks; depletion/burnup benchmarks; and full-core reactor performance benchmarks. We compared Shift results to measured data and other simulated Monte Carlo radiation transport code results, and found very good agreement in a variety of comparison measures. These include prediction of critical eigenvalue, radial and axial pin power distributions, rod worth, leakage spectra, and nuclide inventories over a burn cycle. Based on this validation of Shift, we are confident in Shift to provide reference results for CASL benchmarking.

  12. Online fingerprint verification.

    Science.gov (United States)

    Upendra, K; Singh, S; Kumar, V; Verma, H K

    2007-01-01

    As organizations search for more secure authentication methods for user access, e-commerce, and other security applications, biometrics is gaining increasing attention. With an increasing emphasis on the emerging automatic personal identification applications, fingerprint based identification is becoming more popular. The most widely used fingerprint representation is the minutiae based representation. The main drawback with this representation is that it does not utilize a significant component of the rich discriminatory information available in the fingerprints. Local ridge structures cannot be completely characterized by minutiae. Also, it is difficult quickly to match two fingerprint images containing different number of unregistered minutiae points. In this study filter bank based representation, which eliminates these weakness, is implemented and the overall performance of the developed system is tested. The results have shown that this system can be used effectively for secure online verification applications.

  13. Clinical Trials

    Medline Plus

    Full Text Available ... part in a clinical trial is your decision. Talk with your doctor about all of your treatment options. Together, you can make the ... more about, or taking part in, clinical trials, talk with your doctor. He or she may know about ... clinical trials. NIH Clinical Research Studies ...

  14. Sensor-fusion-based biometric identity verification

    International Nuclear Information System (INIS)

    Carlson, J.J.; Bouchard, A.M.; Osbourn, G.C.; Martinez, R.F.; Bartholomew, J.W.; Jordan, J.B.; Flachs, G.M.; Bao, Z.; Zhu, L.

    1998-02-01

    Future generation automated human biometric identification and verification will require multiple features/sensors together with internal and external information sources to achieve high performance, accuracy, and reliability in uncontrolled environments. The primary objective of the proposed research is to develop a theoretical and practical basis for identifying and verifying people using standoff biometric features that can be obtained with minimal inconvenience during the verification process. The basic problem involves selecting sensors and discovering features that provide sufficient information to reliably verify a person's identity under the uncertainties caused by measurement errors and tactics of uncooperative subjects. A system was developed for discovering hand, face, ear, and voice features and fusing them to verify the identity of people. The system obtains its robustness and reliability by fusing many coarse and easily measured features into a near minimal probability of error decision algorithm

  15. Evaluation verification facilities (EVF) at MINT: concept and implementation

    International Nuclear Information System (INIS)

    Mohamed Hairul Hasmoni; Abd Nassir Ibrahim; Ab Razak Hamzah

    2003-01-01

    EVF facilities and components available are described comprehensively. Objective of establishing EVF as a National Centre for non-destructive testing (NDT) are discussed for various activities of method and equipment validation, R and D on quantitative NDT technique, training and certification, and defect characterization. For a successful activity available at EVF, it is vital that industry participates through input of funding, sponsorship and knowledge sharing. The Malaysian Institute for Nuclear Technology Research (MINT) invested a lot in this facility and ready to share this facility under various mechanisms such as memorandum of understanding (MOU), memorandum of agreement (MOA), contract research or letter of agreement. The facility would be open to industry. Member of NDT community are welcomed to conduct trial and discuss particular areas of interest with others in the industry. Optimising the facility by utilising the facility available and adding new components would make EVF a national centre for NDT and centre of excellence. This paper reviews the concept and implementation of an Evaluation Verification Facility (EVF) at MINT. The types and designs of facilities available are described and characterised by usage NDT. (Author)

  16. A Cluster-Randomized Trial of Restorative Practices: An Illustration to Spur High-Quality Research and Evaluation.

    Science.gov (United States)

    Acosta, Joie D; Chinman, Matthew; Ebener, Patricia; Phillips, Andrea; Xenakis, Lea; Malone, Patrick S

    2016-01-01

    Restorative Practices in schools lack rigorous evaluation studies. As an example of rigorous school-based research, this paper describes the first randomized control trial of restorative practices to date, the Study of Restorative Practices. It is a 5-year, cluster-randomized controlled trial (RCT) of the Restorative Practices Intervention (RPI) in 14 middle schools in Maine to assess whether RPI impacts both positive developmental outcomes and problem behaviors and whether the effects persist during the transition from middle to high school. The two-year RPI intervention began in the 2014-2015 school year. The study's rationale and theoretical concerns are discussed along with methodological concerns including teacher professional development. The theoretical rationale and description of the methods from this study may be useful to others conducting rigorous research and evaluation in this area.

  17. Clinical trial of cancer therapy with heavy ions at heavy ion research facility in lanzhou

    Science.gov (United States)

    Zhang, Hong

    With collaborative efforts of scientists from the Institute of Modern Physics (IMP), Chinese Academy of Sciences and hospitals in Gansu, initial clinical trial on cancer therapy with heavy ions has been successfully carried out in China. From November 2006 to December 2007, 51 patients with superficially-placed tumors were treated with carbon ions at Heavy Ion Research Facility in Lanzhou (HIRFL) within four beam time blocks of 6-11 days, collaborating with the General Hospital of Lanzhou Command and the Tumor Hospital of Gansu Province. Patients and Methods: There were 51 patients (31 males and 20 females) with superficially-placed tumors (squamous cell carcinoma of the skin, basal cell carcinoma of the skin, malignant skin melanoma, sarcoma, lymphoma, breast cancer, metastatic lymph nodes of carcinomas and other skin lesions). The tumors were less than 2.1 cm deep to the skin surface. All patients had histological confirmation of their tumors. Karnofsky Performance Scale (KPS) of all patients was more than 70. The majority of patients were with failures or recurrences of conventional therapies. Median age at the time of radiotherapy (RT) was 55.5 years (range 5-85 years). Patients were immobilized with a vacuum cushion or a head mask and irradiated by carbon ion beams with energy 80-100 MeV/u at spread-out Bragg peak field generated from HIRFL, with two and three-dimensional conformal irradiation methods. Target volume was defined by physical palpation [ultrasonography and Computerized tomography (CT), for some cases]. The clinical target volume (CTV) was defined as the gross total volume GTV with a 0.5-1.0cm margin axially. Field placement for radiation treatment planning was done based on the surface markings. RBE of 2.5-3 within the target volume, and 40-75 GyE with a weekly fractionation of 7 × 3-15 GyE/fraction were used in the trial. Patients had follow-up examinations performed 1 month after treatment, in 1 or 2 months for the first 6 months, and 3

  18. Statistical controversies in clinical research: requiem for the 3 + 3 design for phase I trials.

    Science.gov (United States)

    Paoletti, X; Ezzalfani, M; Le Tourneau, C

    2015-09-01

    More than 95% of published phase I trials have used the 3 + 3 design to identify the dose to be recommended for phase II trials. However, the statistical community agrees on the limitations of the 3 + 3 design compared with model-based approaches. Moreover, the mechanisms of action of targeted agents strongly challenge the hypothesis that the maximum tolerated dose constitutes the optimal dose, and more outcomes including clinical and biological activity increasingly need to be taken into account to identify the optimal dose. We review key elements from clinical publications and from the statistical literature to show that the 3 + 3 design lacks the necessary flexibility to address the challenges of targeted agents. The design issues raised by expansion cohorts, new definitions of dose-limiting toxicity and trials of combinations are not easily addressed by the 3 + 3 design or its extensions. Alternative statistical proposals have been developed to make a better use of the complex data generated by phase I trials. Their applications require a close collaboration between all actors of early phase clinical trials. © The Author 2015. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oup.com.

  19. Sample size calculations for cluster randomised crossover trials in Australian and New Zealand intensive care research.

    Science.gov (United States)

    Arnup, Sarah J; McKenzie, Joanne E; Pilcher, David; Bellomo, Rinaldo; Forbes, Andrew B

    2018-06-01

    The cluster randomised crossover (CRXO) design provides an opportunity to conduct randomised controlled trials to evaluate low risk interventions in the intensive care setting. Our aim is to provide a tutorial on how to perform a sample size calculation for a CRXO trial, focusing on the meaning of the elements required for the calculations, with application to intensive care trials. We use all-cause in-hospital mortality from the Australian and New Zealand Intensive Care Society Adult Patient Database clinical registry to illustrate the sample size calculations. We show sample size calculations for a two-intervention, two 12-month period, cross-sectional CRXO trial. We provide the formulae, and examples of their use, to determine the number of intensive care units required to detect a risk ratio (RR) with a designated level of power between two interventions for trials in which the elements required for sample size calculations remain constant across all ICUs (unstratified design); and in which there are distinct groups (strata) of ICUs that differ importantly in the elements required for sample size calculations (stratified design). The CRXO design markedly reduces the sample size requirement compared with the parallel-group, cluster randomised design for the example cases. The stratified design further reduces the sample size requirement compared with the unstratified design. The CRXO design enables the evaluation of routinely used interventions that can bring about small, but important, improvements in patient care in the intensive care setting.

  20. International Clinical Trials in Latin American and Caribbean Countries: Research and Development to Meet Local Health Needs

    Directory of Open Access Journals (Sweden)

    Ricardo E. da Silva

    2018-01-01

    Full Text Available Introduction: Although international health research involves some benefits for the host countries, such as access to innovative treatments, the research itself may not be aligned with their communities' actual health needs.Objective: To map the global landscape of clinical trials run in Latin American and Caribbean countries and discuss the addressing of local health needs in the agenda of international clinical trials.Methods: The present study is a cross-sectional overview and used data referent to studies registered between 01/01/2014 and 12/31/2014 in the World Health Organization's (WHO International Clinical Trials Registry Platform (ICTRP.Results: Non-communicable diseases such as diabetes, cancer, and asthma—studies which were financed mainly by industries—were the conditions investigated most in the region of Latin America and the Caribbean. The neglected diseases, on the other hand, such as Chagas disease, and dengue, made up 1% of the total number of studies. Hospitals and nonprofit nongovernmental organizations prioritize resources for investigating new drugs for neglected diseases, such as Chagas disease and dengue.Conclusion: The international multicenter clinical trials for investigating new drugs are aligned with the health needs of the region of Latin America and the Caribbean, when one considers the burden resulting from the non-communicable diseases in this region. However, the transmissible diseases, such as tuberculosis and AIDS, and the neglected diseases, such as Chagas disease and dengue, which have an important impact on public health in this region, continue to arouse little interest among the institutions which finance the clinical trials.

  1. Centralized adjudication of cardiovascular end points in cardiovascular and noncardiovascular pharmacologic trials: a report from the Cardiac Safety Research Consortium.

    Science.gov (United States)

    Seltzer, Jonathan H; Turner, J Rick; Geiger, Mary Jane; Rosano, Giuseppe; Mahaffey, Kenneth W; White, William B; Sabol, Mary Beth; Stockbridge, Norman; Sager, Philip T

    2015-02-01

    This white paper provides a summary of presentations and discussions at a cardiovascular (CV) end point adjudication think tank cosponsored by the Cardiac Safety Research Committee and the US Food and Drug Administration (FDA) that was convened at the FDA's White Oak headquarters on November 6, 2013. Attention was focused on the lack of clarity concerning the need for end point adjudication in both CV and non-CV trials: there is currently an absence of widely accepted academic or industry standards and a definitive regulatory policy on how best to structure and use clinical end point committees (CECs). This meeting therefore provided a forum for leaders in the fields of CV clinical trials and CV safety to develop a foundation of initial best practice recommendations for use in future CEC charters. Attendees included representatives from pharmaceutical companies, regulatory agencies, end point adjudication specialist groups, clinical research organizations, and active, academically based adjudicators. The manuscript presents recommendations from the think tank regarding when CV end point adjudication should be considered in trials conducted by cardiologists and by noncardiologists as well as detailing key issues in the composition of a CEC and its charter. In addition, it presents several recommended best practices for the establishment and operation of CECs. The science underlying CV event adjudication is evolving, and suggestions for additional areas of research will be needed to continue to advance this science. This manuscript does not constitute regulatory guidance. Copyright © 2014 Elsevier Inc. All rights reserved.

  2. Ethics approval in applications for open-access clinical trial data: An analysis of researcher statements to clinicalstudydatarequest.com.

    Directory of Open Access Journals (Sweden)

    Derek So

    Full Text Available Although there are a number of online platforms for patient-level clinical trial data sharing from industry sponsors, they are not very harmonized regarding the role of local ethics approval in the research proposal review process. The first and largest of these platforms is ClinicalStudyDataRequest.com (CSDR, which includes over three thousand trials from thirteen sponsors including GlaxoSmithKline, Novartis, Roche, Sanofi, and Bayer. CSDR asks applicants to state whether they have received ethics approval for their research proposal, but in most cases does not require that they submit evidence of approval. However, the website does require that applicants without ethical approval state the reason it was not required. In order to examine the perspectives of researchers on this topic, we coded every response to that question received by CSDR between June 2014 and February 2017. Of 111 applicants who stated they were exempt from ethics approval, 63% mentioned de-identification, 57% mentioned the use of existing data, 33% referred to local or jurisdictional regulations, and 20% referred to the approvals obtained by the original study. We conclude by examining the experience of CSDR within the broader context of the access mechanisms and policies currently being used by other data sharing platforms, and discuss how our findings might be used to help clinical trial data providers design clear and informative access documents.

  3. WE-G-BRB-00: NIH-Funded Research: Instrumental in the Pursuit of Clinical Trials and Technological Innovations

    International Nuclear Information System (INIS)

    2015-01-01

    Over the past 20 years the NIH has funded individual grants, program projects grants, and clinical trials which have been instrumental in advancing patient care. The ways that each grant mechanism lends itself to the different phases of translating research into clinical practice will be described. Major technological innovations, such as IMRT and proton therapy, have been advanced with R01-type and P01-type funding and will be discussed. Similarly, the role of program project grants in identifying and addressing key hypotheses on the potential of 3D conformal therapy, normal tissue-guided dose escalation and motion management will be described. An overview will be provided regarding how these technological innovations have been applied to multi-institutional NIH-sponsored trials. Finally, the panel will discuss regarding which research questions should be funded by the NIH to inspire the next advances in radiation therapy. Learning Objectives: Understand the different funding mechanisms of the NIH Learn about research advances that have led to innovation in delivery Review achievements due to NIH-funded program project grants in radiotherapy over the past 20 years Understand example advances achieved with multi-institutional clinical trials NIH

  4. A Quantitative Approach to the Formal Verification of Real-Time Systems.

    Science.gov (United States)

    1996-09-01

    Computer Science A Quantitative Approach to the Formal Verification of Real - Time Systems Sergio Vale Aguiar Campos September 1996 CMU-CS-96-199...ptisiic raieaiSI v Diambimos Lboiamtad _^ A Quantitative Approach to the Formal Verification of Real - Time Systems Sergio Vale Aguiar Campos...implied, of NSF, the Semiconduc- tor Research Corporation, ARPA or the U.S. government. Keywords: real - time systems , formal verification, symbolic

  5. Ethylenediurea (EDU): A research tool for assessment and verification of the effects of ground level ozone on plants under natural conditions

    Energy Technology Data Exchange (ETDEWEB)

    Manning, William J. [Department of Plant, Soil and Insect Sciences, University of Massachusetts, Amherst, MA 01003-9320 (United States); Paoletti, Elena, E-mail: e.paoletti@ipp.cnr.it [IPP CNR, Via Madonna del Piano 10, I-50019 Sesto Fiorentino (Italy); Sandermann, Heinrich [ecotox.freiburg, Schubertstr. 1, D-79104 Freiburg (Germany); Helmholtz Zentrum Muenchen, German Research Center for Environmental Health, Institute of Biochemical Plant Pathology, D-85764 Neuherberg (Germany); Ernst, Dieter [ecotox.freiburg, Schubertstr. 1, D-79104 Freiburg (Germany)

    2011-12-15

    Ethylenediurea (EDU) has been widely used to prevent ozone (O{sub 3}) injury and crop losses in crop plants and growth reductions in forest trees. Successful use requires establishing a dose/response curve for EDU and the proposed plant in the absence of O{sub 3} and in the presence of O{sub 3} before initiating multiple applications to prevent O{sub 3} injury. EDU can be used to verify foliar O{sub 3} symptoms in the field, and to screen plants for sensitivity to O{sub 3} under ambient conditions. Despite considerable research, the mode of action of EDU remains elusive. Additional research on the mode of action of EDU in suppressing O{sub 3} injury in plants may also be helpful in understanding the mode of action of O{sub 3} in causing injury in plants. - EDU is a verified and effective tool for the assessment of the effects of ozone on plants.

  6. Compressive sensing using optimized sensing matrix for face verification

    Science.gov (United States)

    Oey, Endra; Jeffry; Wongso, Kelvin; Tommy

    2017-12-01

    Biometric appears as one of the solutions which is capable in solving problems that occurred in the usage of password in terms of data access, for example there is possibility in forgetting password and hard to recall various different passwords. With biometrics, physical characteristics of a person can be captured and used in the identification process. In this research, facial biometric is used in the verification process to determine whether the user has the authority to access the data or not. Facial biometric is chosen as its low cost implementation and generate quite accurate result for user identification. Face verification system which is adopted in this research is Compressive Sensing (CS) technique, in which aims to reduce dimension size as well as encrypt data in form of facial test image where the image is represented in sparse signals. Encrypted data can be reconstructed using Sparse Coding algorithm. Two types of Sparse Coding namely Orthogonal Matching Pursuit (OMP) and Iteratively Reweighted Least Squares -ℓp (IRLS-ℓp) will be used for comparison face verification system research. Reconstruction results of sparse signals are then used to find Euclidean norm with the sparse signal of user that has been previously saved in system to determine the validity of the facial test image. Results of system accuracy obtained in this research are 99% in IRLS with time response of face verification for 4.917 seconds and 96.33% in OMP with time response of face verification for 0.4046 seconds with non-optimized sensing matrix, while 99% in IRLS with time response of face verification for 13.4791 seconds and 98.33% for OMP with time response of face verification for 3.1571 seconds with optimized sensing matrix.

  7. A deviation from standard design? Clinical trials, research ethics committees, and the regulatory co-construction of organizational deviance.

    Science.gov (United States)

    Hedgecoe, Adam

    2014-02-01

    Focusing on the high-profile drug disaster at London's Northwick Park Hospital in 2006, this article explores how such an event can be seen as an example of organizational deviance co-constructed between the company running the research and the research ethics committee which approved the trial. This deviance was the result of the normalization of a specific dosing practice in the broader regulatory field, allowing the researchers and regulators to take a risky dosing strategy for granted as best practice. Drawing on the work of Diane Vaughan, this article uses interview data with researchers and members of the research ethics committee concerned as well as documentary material, to show how work group cultures between regulators and those they are intended to oversee are maintained, and how the culturally embedded assumptions of such work groups can result in organizational and regulatory deviance.

  8. Towards a More Competitive Italy in Clinical Research: The Survey of Attitudes towards Trial sites in Europe (The SAT-EU Study TM

    Directory of Open Access Journals (Sweden)

    Marta Gehring

    2014-11-01

    Full Text Available  BackgroundItaly is Europe’s third largest pharmaceutical market, yet it ranks only ninth in the number of NIH-registered clinical trials per capita. The aim of our study was to explore stakeholders’ perception of Italy as place to undertake clinical trials, and to estimate the potential economic impact of selected reforms in terms of incremental trial activity.MethodsThe Survey of Attitudes towards Trials in Europe (SAT-EU Study was an anonymous, web-based survey which systematically assessed factors impacting clinical trial site selection in Europe. Estimates of Italian economic impact were developed in collaboration with AICRO (Association of Italian Contract Research Organisations.ResultsResponses were obtained from 485 professionals in 34 countries (15% residing in Italy representing over 100 institutions, spanning BioPharma Clinical Research Organizations (CROs, and Academic Clinical Trial Units (CTUs. Italy ranked tenth of twelve in terms of accessibility and transparency of information required to run clinical trials, and last with respect to predictability and speed of Ethics Committees. Costs of running clinical trials were not considered critical, whereas, fragmented and slow approval process was. Streamlined centralized trial authorization would translate into an estimated 1.1 billion Euros of incremental trial investments over three years. ConclusionsClinical trial professionals consider Italy’s governance of clinical research suboptimal, among the worst in Europe, and indicate that much could be done to make Italy more attractive for clinical trial investments. The present study also provides evidence about stakeholders’ willingness to invest in trials and its economic consequences provided effective reforms are put in place. 

  9. Description and verification of a U.S. Naval Research Lab's loosely coupled data assimilation system for the Navy's Earth System Model

    Science.gov (United States)

    Barton, N. P.; Metzger, E. J.; Smedstad, O. M.; Ruston, B. C.; Wallcraft, A. J.; Whitcomb, T.; Ridout, J. A.; Zamudio, L.; Posey, P.; Reynolds, C. A.; Richman, J. G.; Phelps, M.

    2017-12-01

    The Naval Research Laboratory is developing an Earth System Model (NESM) to provide global environmental information to meet Navy and Department of Defense (DoD) operations and planning needs from the upper atmosphere to under the sea. This system consists of a global atmosphere, ocean, ice, wave, and land prediction models and the individual models include: atmosphere - NAVy Global Environmental Model (NAVGEM); ocean - HYbrid Coordinate Ocean Model (HYCOM); sea ice - Community Ice CodE (CICE); WAVEWATCH III™; and land - NAVGEM Land Surface Model (LSM). Data assimilation is currently loosely coupled between the atmosphere component using a 6-hour update cycle in the Naval Research Laboratory (NRL) Atmospheric Variational Data Assimilation System - Accelerated Representer (NAVDAS-AR) and the ocean/ice components using a 24-hour update cycle in the Navy Coupled Ocean Data Assimilation (NCODA) with 3 hours of incremental updating. This presentation will describe the US Navy's coupled forecast model, the loosely coupled data assimilation, and compare results against stand-alone atmosphere and ocean/ice models. In particular, we will focus on the unique aspects of this modeling system, which includes an eddy resolving ocean model and challenges associated with different update-windows and solvers for the data assimilation in the atmosphere and ocean. Results will focus on typical operational diagnostics for atmosphere, ocean, and ice analyses including 500 hPa atmospheric height anomalies, low-level winds, temperature/salinity ocean depth profiles, ocean acoustical proxies, sea ice edge, and sea ice drift. Overall, the global coupled system is performing with comparable skill to the stand-alone systems.

  10. Numident Online Verification Utility (NOVU)

    Data.gov (United States)

    Social Security Administration — NOVU is a mainframe application that accesses the NUMIDENT to perform real-time SSN verifications. This program is called by other SSA online programs that serve as...

  11. Advancing Disarmament Verification Tools: A Task for Europe?

    International Nuclear Information System (INIS)

    Göttsche, Malte; Kütt, Moritz; Neuneck, Götz; Niemeyer, Irmgard

    2015-01-01

    A number of scientific-technical activities have been carried out to establish more robust and irreversible disarmament verification schemes. Regardless of the actual path towards deeper reductions in nuclear arsenals or their total elimination in the future, disarmament verification will require new verification procedures and techniques. This paper discusses the information that would be required as a basis for building confidence in disarmament, how it could be principally verified and the role Europe could play. Various ongoing activities are presented that could be brought together to produce a more intensified research and development environment in Europe. The paper argues that if ‘effective multilateralism’ is the main goal of the European Union’s (EU) disarmament policy, EU efforts should be combined and strengthened to create a coordinated multilateral disarmament verification capacity in the EU and other European countries. The paper concludes with several recommendations that would have a significant impact on future developments. Among other things, the paper proposes a one-year review process that should include all relevant European actors. In the long run, an EU Centre for Disarmament Verification could be envisaged to optimize verification needs, technologies and procedures.

  12. Verification in Referral-Based Crowdsourcing

    Science.gov (United States)

    Naroditskiy, Victor; Rahwan, Iyad; Cebrian, Manuel; Jennings, Nicholas R.

    2012-01-01

    Online social networks offer unprecedented potential for rallying a large number of people to accomplish a given task. Here we focus on information gathering tasks where rare information is sought through “referral-based crowdsourcing”: the information request is propagated recursively through invitations among members of a social network. Whereas previous work analyzed incentives for the referral process in a setting with only correct reports, misreporting is known to be both pervasive in crowdsourcing applications, and difficult/costly to filter out. A motivating example for our work is the DARPA Red Balloon Challenge where the level of misreporting was very high. In order to undertake a formal study of verification, we introduce a model where agents can exert costly effort to perform verification and false reports can be penalized. This is the first model of verification and it provides many directions for future research, which we point out. Our main theoretical result is the compensation scheme that minimizes the cost of retrieving the correct answer. Notably, this optimal compensation scheme coincides with the winning strategy of the Red Balloon Challenge. PMID:23071530

  13. Clinical trial aims to study immunotherapy for central nervous system tumors | Center for Cancer Research

    Science.gov (United States)

    A new clinical trial aims to determine whether nivolumab, an immune checkpoint inhibitor, can improve control of cancer for patients with several types of tumors of the central nervous system (CNS). The CNS is composed of the brain and spinal cord and the cause of most CNS tumors in adults is unknown. Learn more...

  14. New trial evaluates investigational drug for endometrial and breast cancers | Center for Cancer Research

    Science.gov (United States)

    A new clinical trial is testing ONC201, an investigational drug that in laboratory studies has been shown to kill breast and endometrial cancer cells most likely by destroying mitochondria within the tumor cells. Mitochondria are the “powerhouse” of the cell, and blocking its activity may kill tumor cells and shrink tumors in human patients.

  15. ENVIRONMENTAL TECHNOLOGY VERIFICATION REPORT: MOBILE SOURCE RETROFIT AIR POLLUTION CONTROL DEVICES: CLEAN CLEAR FUEL TECHNOLOGIES, INC.’S, UNIVERSAL FUEL CELL

    Science.gov (United States)

    The U.S. EPA's Office of Research and Development operates the Environmental Technology Verification (ETV) program to facilitate the deployment of innovative technologies through performance verification and information dissemination. Congress funds ETV in response to the belief ...

  16. Environmental Technology Verification: Biological Inactivation Efficiency by HVAC In-Duct Ultraviolet Light Systems--American Ultraviolet Corporation, DC24-6-120 [EPA600etv08005

    Science.gov (United States)

    The Air Pollution Control Technology Verification Center (APCT Center) is operated by RTI International (RTI), in cooperation with EPA's National Risk Management Research Laboratory. The APCT Center conducts verifications of technologies that clean air in ventilation systems, inc...

  17. Modality Switching in a Property Verification Task: An ERP Study of What Happens When Candles Flicker after High Heels Click.

    Science.gov (United States)

    Collins, Jennifer; Pecher, Diane; Zeelenberg, René; Coulson, Seana

    2011-01-01

    The perceptual modalities associated with property words, such as flicker or click, have previously been demonstrated to affect subsequent property verification judgments (Pecher et al., 2003). Known as the conceptual modality switch effect, this finding supports the claim that brain systems for perception and action help subserve the representation of concepts. The present study addressed the cognitive and neural substrate of this effect by recording event-related potentials (ERPs) as participants performed a property verification task with visual or auditory properties in key trials. We found that for visual property verifications, modality switching was associated with an increased amplitude N400. For auditory verifications, switching led to a larger late positive complex. Observed ERP effects of modality switching suggest property words access perceptual brain systems. Moreover, the timing and pattern of the effects suggest perceptual systems impact the decision-making stage in the verification of auditory properties, and the semantic stage in the verification of visual properties.

  18. Verification of a One-Dimensional Model of CO2 Atmospheric Transport Inside and Above a Forest Canopy Using Observations at the Norunda Research Station

    Science.gov (United States)

    Kovalets, Ivan; Avila, Rodolfo; Mölder, Meelis; Kovalets, Sophia; Lindroth, Anders

    2018-07-01

    A model of CO2 atmospheric transport in vegetated canopies is tested against measurements of the flow, as well as CO2 concentrations at the Norunda research station located inside a mixed pine-spruce forest. We present the results of simulations of wind-speed profiles and CO2 concentrations inside and above the forest canopy with a one-dimensional model of profiles of the turbulent diffusion coefficient above the canopy accounting for the influence of the roughness sub-layer on turbulent mixing according to Harman and Finnigan (Boundary-Layer Meteorol 129:323-351, 2008; hereafter HF08). Different modelling approaches are used to define the turbulent exchange coefficients for momentum and concentration inside the canopy: (1) the modified HF08 theory—numerical solution of the momentum and concentration equations with a non-constant distribution of leaf area per unit volume; (2) empirical parametrization of the turbulent diffusion coefficient using empirical data concerning the vertical profiles of the Lagrangian time scale and root-mean-square deviation of the vertical velocity component. For neutral, daytime conditions, the second-order turbulence model is also used. The flexibility of the empirical model enables the best fit of the simulated CO2 concentrations inside the canopy to the observations, with the results of simulations for daytime conditions inside the canopy layer only successful provided the respiration fluxes are properly considered. The application of the developed model for radiocarbon atmospheric transport released in the form of ^{14}CO2 is presented and discussed.

  19. Bibliography for Verification and Validation in Computational Simulation

    International Nuclear Information System (INIS)

    Oberkampf, W.L.

    1998-01-01

    A bibliography has been compiled dealing with the verification and validation of computational simulations. The references listed in this bibliography are concentrated in the field of computational fluid dynamics (CFD). However, references from the following fields are also included: operations research, heat transfer, solid dynamics, software quality assurance, software accreditation, military systems, and nuclear reactor safety. This bibliography, containing 221 references, is not meant to be comprehensive. It was compiled during the last ten years in response to the author's interest and research in the methodology for verification and validation. The emphasis in the bibliography is in the following areas: philosophy of science underpinnings, development of terminology and methodology, high accuracy solutions for CFD verification, experimental datasets for CFD validation, and the statistical quantification of model validation. This bibliography should provide a starting point for individual researchers in many fields of computational simulation in science and engineering

  20. Bibliography for Verification and Validation in Computational Simulations

    Energy Technology Data Exchange (ETDEWEB)

    Oberkampf, W.L.

    1998-10-01

    A bibliography has been compiled dealing with the verification and validation of computational simulations. The references listed in this bibliography are concentrated in the field of computational fluid dynamics (CFD). However, references from the following fields are also included: operations research, heat transfer, solid dynamics, software quality assurance, software accreditation, military systems, and nuclear reactor safety. This bibliography, containing 221 references, is not meant to be comprehensive. It was compiled during the last ten years in response to the author's interest and research in the methodology for verification and validation. The emphasis in the bibliography is in the following areas: philosophy of science underpinnings, development of terminology and methodology, high accuracy solutions for CFD verification, experimental datasets for CFD validation, and the statistical quantification of model validation. This bibliography should provide a starting point for individual researchers in many fields of computational simulation in science and engineering.

  1. Experimental inventory verification system

    International Nuclear Information System (INIS)

    Steverson, C.A.; Angerman, M.I.

    1991-01-01

    As Low As Reasonably Achievable (ALARA) goals and Department of Energy (DOE) inventory requirements are frequently in conflict at facilities across the DOE complex. The authors wish, on one hand, to verify the presence of correct amounts of nuclear materials that are in storage or in process; yet on the other hand, we wish to achieve ALARA goals by keeping individual and collective exposures as low as social, technical, economic, practical, and public policy considerations permit. The Experimental Inventory Verification System (EIVSystem) is a computer-based, camera-driven system that utilizes image processing technology to detect change in vault areas. Currently in the test and evaluation phase at Idaho National Engineering Laboratory, this system guards personnel. The EIVSystem continually monitors the vault, providing proof of changed status for objects sorted within the vault. This paper reports that these data could provide the basis for reducing inventory requirements when no change has occurred, thus helping implement ALARA policy; the data will also help describe there target area of an inventory when change has been shown to occur

  2. Woodward Effect Experimental Verifications

    Science.gov (United States)

    March, Paul

    2004-02-01

    The work of J. F. Woodward (1990 1996a; 1996b; 1998; 2002a; 2002b; 2004) on the existence of ``mass fluctuations'' and their use in exotic propulsion schemes was examined for possible application in improving space flight propulsion and power generation. Woodward examined Einstein's General Relativity Theory (GRT) and assumed that if the strong Machian interpretation of GRT as well as gravitational / inertia like Wheeler-Feynman radiation reaction forces hold, then when an elementary particle is accelerated through a potential gradient, its rest mass should fluctuate around its mean value during its acceleration. Woodward also used GRT to clarify the precise experimental conditions necessary for observing and exploiting these mass fluctuations or ``Woodward effect'' (W-E). Later, in collaboration with his ex-graduate student T. Mahood, they also pushed the experimental verification boundaries of these proposals. If these purported mass fluctuations occur as Woodward claims, and his assumption that gravity and inertia are both byproducts of the same GRT based phenomenon per Mach's Principle is correct, then many innovative applications such as propellantless propulsion and gravitational exotic matter generators may be feasible. This paper examines the reality of mass fluctuations and the feasibility of using the W-E to design propellantless propulsion devices in the near to mid-term future. The latest experimental results, utilizing MHD-like force rectification systems, will also be presented.

  3. Verification of hypergraph states

    Science.gov (United States)

    Morimae, Tomoyuki; Takeuchi, Yuki; Hayashi, Masahito

    2017-12-01

    Hypergraph states are generalizations of graph states where controlled-Z gates on edges are replaced with generalized controlled-Z gates on hyperedges. Hypergraph states have several advantages over graph states. For example, certain hypergraph states, such as the Union Jack states, are universal resource states for measurement-based quantum computing with only Pauli measurements, while graph state measurement-based quantum computing needs non-Clifford basis measurements. Furthermore, it is impossible to classically efficiently sample measurement results on hypergraph states unless the polynomial hierarchy collapses to the third level. Although several protocols have been proposed to verify graph states with only sequential single-qubit Pauli measurements, there was no verification method for hypergraph states. In this paper, we propose a method for verifying a certain class of hypergraph states with only sequential single-qubit Pauli measurements. Importantly, no i.i.d. property of samples is assumed in our protocol: any artificial entanglement among samples cannot fool the verifier. As applications of our protocol, we consider verified blind quantum computing with hypergraph states, and quantum computational supremacy demonstrations with hypergraph states.

  4. Communication is the key to success in pragmatic clinical trials in Practice-based Research Networks (PBRNs).

    Science.gov (United States)

    Bertram, Susan; Graham, Deborah; Kurland, Marge; Pace, Wilson; Madison, Suzanne; Yawn, Barbara P

    2013-01-01

    Effective communication is the foundation of feasibility and fidelity in practice-based pragmatic research studies. Doing a study with practices spread over several states requires long-distance communication strategies, including E-mails, faxes, telephone calls, conference calls, and texting. Compared with face-to-face communication, distance communication strategies are less familiar to most study coordinators and research teams. Developing and ensuring comfort with distance communications requires additional time and use of different talents and expertise than those required for face-to-face communication. It is necessary to make sure that messages are appropriate for the medium, clearly crafted, and presented in a manner that facilitates practices receiving and understanding the information. This discussion is based on extensive experience of 2 groups who have worked collaboratively on several large, federally funded, pragmatic trials in a practice-based research network. The goal of this article is to summarize lessons learned to facilitate the work of other research teams.

  5. Informed consent from cognitively impaired persons participating in research trials: comparative law observations.

    Science.gov (United States)

    Petrini, Carlo

    2011-01-01

    This article addresses the ethical requirements to be considered when conducting clinical trials involving human subjects whose mental condition limits their ability to understand the information and to express fully autonomous and informed consent. It does not address other categories of vulnerable persons, such as children, or advanced directives concerning end-of-life care. There are many ethical issues entailed in clinical trials involving subjects with mental disabilities: how to obtain informed consent, balancing risks and benefits, balancing individual benefits with collective scientific and social interests, legal representation and many more. This article focuses on the issues surrounding the concept of minimal risk and the relationship between informed consent and risk. These issues are addressed with particular emphasis on the regulations adopted by the European Union and the federal government of the United States of America. The conclusion proposes a list of working criteria.

  6. Informed consent from cognitively impaired persons participating in research trials: comparative law observations

    Directory of Open Access Journals (Sweden)

    Carlo Petrini

    2011-12-01

    Full Text Available This article addresses the ethical requirements to be considered when conducting clinical trials involving human subjects whose mental condition limits their ability to understand the information and to express fully autonomous and informed consent. It does not address other categories of vulnerable persons, such as children, or advanced directives concerning end-of-life care. There are many ethical issues entailed in clinical trials involving subjects with mental disabilities: how to obtain informed consent, balancing risks and benefits, balancing individual benefits with collective scientific and social interests, legal representation and many more. This article focuses on the issues surrounding the concept of minimal risk and the relationship between informed consent and risk. These issues are addressed with particular emphasis on the regulations adopted by the European Union and the federal government of the United States of America. The conclusion proposes a list of working criteria.

  7. Inconsistencies in quality of life data collection in clinical trials: a potential source of bias? Interviews with research nurses and trialists.

    Science.gov (United States)

    Kyte, Derek; Ives, Jonathan; Draper, Heather; Keeley, Thomas; Calvert, Melanie

    2013-01-01

    Patient-reported outcomes (PROs), such as health-related quality of life (HRQL) are increasingly used to evaluate treatment effectiveness in clinical trials, are valued by patients, and may inform important decisions in the clinical setting. It is of concern, therefore, that preliminary evidence, gained from group discussions at UK-wide Medical Research Council (MRC) quality of life training days, suggests there are inconsistent standards of HRQL data collection in trials and appropriate training and education is often lacking. Our objective was to investigate these reports, to determine if they represented isolated experiences, or were indicative of a potentially wider problem. We undertook a qualitative study, conducting 26 semi-structured interviews with research nurses, data managers, trial coordinators and research facilitators involved in the collection and entry of HRQL data in clinical trials, across one primary care NHS trust, two secondary care NHS trusts and two clinical trials units in the UK. We used conventional content analysis to analyze and interpret our data. Our study participants reported (1) inconsistent standards in HRQL measurement, both between, and within, trials, which appeared to risk the introduction of bias; (2), difficulties in dealing with HRQL data that raised concern for the well-being of the trial participant, which in some instances led to the delivery of non-protocol driven co-interventions, (3), a frequent lack of HRQL protocol content and appropriate training and education of trial staff, and (4) that HRQL data collection could be associated with emotional and/or ethical burden. Our findings suggest there are inconsistencies in the standards of HRQL data collection in some trials resulting from a general lack of HRQL-specific protocol content, training and education. These inconsistencies could lead to biased HRQL trial results. Future research should aim to develop HRQL guidelines and training programmes aimed at supporting

  8. Collaborative research between academia and industry using a large clinical trial database: a case study in Alzheimer's disease

    Directory of Open Access Journals (Sweden)

    Jones Roy

    2011-10-01

    Full Text Available Abstract Background Large clinical trials databases, developed over the course of a comprehensive clinical trial programme, represent an invaluable resource for clinical researchers. Data mining projects sponsored by industry that use these databases, however, are often not viewed favourably in the academic medical community because of concerns that commercial, rather than scientific, goals are the primary purpose of such endeavours. Thus, there are few examples of sustained collaboration between leading academic clinical researchers and industry professionals in a large-scale data mining project. We present here a successful example of this type of collaboration in the field of dementia. Methods The Donepezil Data Repository comprised 18 randomised, controlled trials conducted between 1991 and 2005. The project team at Pfizer determined that the data mining process should be guided by a diverse group of leading Alzheimer's disease clinical researchers called the "Expert Working Group." After development of a list of potential faculty members, invitations were extended and a group of seven members was assembled. The Working Group met regularly with Eisai/Pfizer clinicians and statisticians to discuss the data, identify issues that were currently of interest in the academic and clinical communities that might lend themselves to investigation using these data, and note gaps in understanding or knowledge of Alzheimer's disease that these data could address. Leadership was provided by the Pfizer Clinical Development team leader; Working Group members rotated responsibility for being lead and co-lead for each investigation and resultant publication. Results Six manuscripts, each published in a leading subspecialty journal, resulted from the group's work. Another project resulted in poster presentations at international congresses and two were cancelled due to resource constraints. Conclusions The experience represents a particular approach to

  9. The evaluation of complex clinical trial protocols: resources available to research ethics committees and the use of clinical trial registries--a case study.

    Science.gov (United States)

    Homedes, Núria; Ugalde, Antonio

    2015-06-01

    To assess the potential role of clinical trial (CT) registries and other resources available to research ethics committees (RECs) in the evaluation of complex CT protocols in low-income and middle-income countries. Using a case study approach, the authors examined the decision-making process of a REC in Argentina and its efforts to use available resources to decide on a complex protocol. We also analysed the information in the USA and other CT registries and consulted 24 CT experts in seven countries. Information requested by the Argentinean REC from other national RECs and ethics' experts was not useful to verify the adequacy of the REC's decision whether or not to approve the CT. The responses from the national regulatory agency and the sponsor were not helpful either. The identification of international resources that could assist was beyond the REC's capability. The information in the USA and other CT registries is limited, and at times misleading; and its accuracy is not verified by register keepers. RECs have limited access to experts and institutions that could assist them in their deliberations. Sponsors do not always answer RECs' request for information to properly conduct the ethical and methodological assessment of CT protocols. The usefulness of the CT registries is curtailed by the lack of appropriate codes and by data errors. Information about reasons for rejection, withdrawal or suspension of the trial should be included in the registries. Establishing formal channels of communication among national and foreign RECs and with independent international reference centres could strengthen the ethical review of CT protocols. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  10. Top-down design and verification methodology for analog mixed-signal integrated circuits

    NARCIS (Netherlands)

    Beviz, P.

    2016-01-01

    The current report contains the introduction of a novel Top-Down Design and Verification methodology for AMS integrated circuits. With the introduction of new design and verification flow, more reliable and efficient development of AMS ICs is possible. The assignment incorporated the research on the

  11. 78 FR 28812 - Energy Efficiency Program for Industrial Equipment: Petition of UL Verification Services Inc. for...

    Science.gov (United States)

    2013-05-16

    ... are engineers. UL today is comprised of five businesses, Product Safety, Verification Services, Life..., Director--Global Technical Research, UL Verification Services. Subscribed and sworn to before me this 20... (431.447(c)(4)) General Personnel Overview UL is a global independent safety science company with more...

  12. Development and Verification of Body Armor Target Geometry Created Using Computed Tomography Scans

    Science.gov (United States)

    2017-07-13

    Computed Tomography Scans by Autumn R Kulaga, Kathryn L Loftis, and Eric Murray Approved for public release; distribution is...Army Research Laboratory Development and Verification of Body Armor Target Geometry Created Using Computed Tomography Scans by Autumn R Kulaga...Development and Verification of Body Armor Target Geometry Created Using Computed Tomography Scans 5a. CONTRACT NUMBER 5b. GRANT NUMBER 5c

  13. Design of verification platform for wireless vision sensor networks

    Science.gov (United States)

    Ye, Juanjuan; Shang, Fei; Yu, Chuang

    2017-08-01

    At present, the majority of research for wireless vision sensor networks (WVSNs) still remains in the software simulation stage, and the verification platforms of WVSNs that available for use are very few. This situation seriously restricts the transformation from theory research of WVSNs to practical application. Therefore, it is necessary to study the construction of verification platform of WVSNs. This paper combines wireless transceiver module, visual information acquisition module and power acquisition module, designs a high-performance wireless vision sensor node whose core is ARM11 microprocessor and selects AODV as the routing protocol to set up a verification platform called AdvanWorks for WVSNs. Experiments show that the AdvanWorks can successfully achieve functions of image acquisition, coding, wireless transmission, and obtain the effective distance parameters between nodes, which lays a good foundation for the follow-up application of WVSNs.

  14. Challenges for effective WMD verification

    International Nuclear Information System (INIS)

    Andemicael, B.

    2006-01-01

    Effective verification is crucial to the fulfillment of the objectives of any disarmament treaty, not least as regards the proliferation of weapons of mass destruction (WMD). The effectiveness of the verification package depends on a number of factors, some inherent in the agreed structure and others related to the type of responses demanded by emerging challenges. The verification systems of three global agencies-the IAEA, the Comprehensive Nuclear-Test-Ban Treaty Organization (CTBTO, currently the Preparatory Commission), and the Organization for the Prohibition of Chemical Weapons (OPCW)-share similarities in their broad objectives of confidence-building and deterrence by assuring members that rigorous verification would deter or otherwise detect non-compliance. Yet they are up against various constraints and other issues, both internal and external to the treaty regime. These constraints pose major challenges to the effectiveness and reliability of the verification operations. In the nuclear field, the IAEA safeguards process was the first to evolve incrementally from modest Statute beginnings to a robust verification system under the global Treaty on the Non-Proliferation of Nuclear Weapons (NPT). The nuclear non-proliferation regime is now being supplemented by a technology-intensive verification system of the nuclear test-ban treaty (CTBT), a product of over three decades of negotiation. However, there still remain fundamental gaps and loopholes in the regime as a whole, which tend to diminish the combined effectiveness of the IAEA and the CTBT verification capabilities. He three major problems are (a) the lack of universality of membership, essentially because of the absence of three nuclear weapon-capable States-India, Pakistan and Israel-from both the NPT and the CTBT, (b) the changes in US disarmament policy, especially in the nuclear field, and (c) the failure of the Conference on Disarmament to conclude a fissile material cut-off treaty. The world is

  15. Reports from the 2010 Clinical and Translational Cancer Research Think Tank meeting: design strategies for personalized therapy trials.

    Science.gov (United States)

    Berry, Donald A; Herbst, Roy S; Rubin, Eric H

    2012-02-01

    It has long been evident that cancer is a heterogeneous disease, but only relatively recently have we come to realize the extent of this heterogeneity. No single therapy is effective for every patient with tumors having the same histology. A clinical strategy based on a single-therapy approach results in overtreatment for the majority of patients. Biomarkers can be considered as knives that dissect the disease ever more finely. The future of clinical research will be based on learning whether certain therapies are more appropriate than others for biomarker-defined subsets of patients. Therapies will eventually be tailored to narrow biomarker subsets. The ability to determine which therapies are appropriate for which patients requires information from biological science as well as empirical evidence from clinical trials. Neither is easy to achieve. Here we describe some nascent approaches for designing clinical trials that are biomarker-based and adaptive. Our focus is on adaptive trials that address many questions at once. In a way, these clinical experiments are themselves part of a much larger experiment: learning how (or whether it is possible) to design experiments that match patients in small subsets of disease with therapies that are especially effective and possibly even curative for them.

  16. LesionTracker: Extensible Open-Source Zero-Footprint Web Viewer for Cancer Imaging Research and Clinical Trials.

    Science.gov (United States)

    Urban, Trinity; Ziegler, Erik; Lewis, Rob; Hafey, Chris; Sadow, Cheryl; Van den Abbeele, Annick D; Harris, Gordon J

    2017-11-01

    Oncology clinical trials have become increasingly dependent upon image-based surrogate endpoints for determining patient eligibility and treatment efficacy. As therapeutics have evolved and multiplied in number, the tumor metrics criteria used to characterize therapeutic response have become progressively more varied and complex. The growing intricacies of image-based response evaluation, together with rising expectations for rapid and consistent results reporting, make it difficult for site radiologists to adequately address local and multicenter imaging demands. These challenges demonstrate the need for advanced cancer imaging informatics tools that can help ensure protocol-compliant image evaluation while simultaneously promoting reviewer efficiency. LesionTracker is a quantitative imaging package optimized for oncology clinical trial workflows. The goal of the project is to create an open source zero-footprint viewer for image analysis that is designed to be extensible as well as capable of being integrated into third-party systems for advanced imaging tools and clinical trials informatics platforms. Cancer Res; 77(21); e119-22. ©2017 AACR . ©2017 American Association for Cancer Research.

  17. Verification of the thermal design of electronic equipment

    Energy Technology Data Exchange (ETDEWEB)

    Hienonen, R.; Karjalainen, M.; Lankinen, R. [VTT Automation, Espoo (Finland). ProTechno

    1997-12-31

    The project `Verification of the thermal design of electronic equipment` studied the methodology to be followed in the verification of thermal design of electronic equipment. This project forms part of the `Cool Electronics` research programme funded by TEKES, the Finnish Technology Development Centre. This project was carried out jointly by VTT Automation, Lappeenranta University of Technology, Nokia Research Center and ABB Industry Oy VSD-Technology. The thermal design of electronic equipment has a significant impact on the cost, reliability, tolerance to different environments, selection of components and materials, and ergonomics of the product. This report describes the method for verification of thermal design. It assesses the goals set for thermal design, environmental requirements, technical implementation of the design, thermal simulation and modelling, and design qualification testing and the measurements needed. The verification method covers all packaging levels of electronic equipment from the system level to the electronic component level. The method described in this report can be used as part of the quality system of a corporation. The report includes information about the measurement and test methods needed in the verification process. Some measurement methods for the temperature, flow and pressure of air are described. (orig.) Published in Finnish VTT Julkaisuja 824. 22 refs.

  18. Disarmament Verification - the OPCW Experience

    International Nuclear Information System (INIS)

    Lodding, J.

    2010-01-01

    The Chemical Weapons Convention is the only multilateral treaty that bans completely an entire category of weapons of mass destruction under international verification arrangements. Possessor States, i.e. those that have chemical weapons stockpiles at the time of becoming party to the CWC, commit to destroying these. All States undertake never to acquire chemical weapons and not to help other States acquire such weapons. The CWC foresees time-bound chemical disarmament. The deadlines for destruction for early entrants to the CWC are provided in the treaty. For late entrants, the Conference of States Parties intervenes to set destruction deadlines. One of the unique features of the CWC is thus the regime for verifying destruction of chemical weapons. But how can you design a system for verification at military sites, while protecting military restricted information? What degree of assurance is considered sufficient in such circumstances? How do you divide the verification costs? How do you deal with production capability and initial declarations of existing stockpiles? The founders of the CWC had to address these and other challenges in designing the treaty. Further refinement of the verification system has followed since the treaty opened for signature in 1993 and since inspection work was initiated following entry-into-force of the treaty in 1997. Most of this work concerns destruction at the two large possessor States, Russia and the United States. Perhaps some of the lessons learned from the OPCW experience may be instructive in a future verification regime for nuclear weapons. (author)

  19. Verification of Chemical Weapons Destruction

    International Nuclear Information System (INIS)

    Lodding, J.

    2010-01-01

    The Chemical Weapons Convention is the only multilateral treaty that bans completely an entire category of weapons of mass destruction under international verification arrangements. Possessor States, i.e. those that have chemical weapons stockpiles at the time of becoming party to the CWC, commit to destroying these. All States undertake never to acquire chemical weapons and not to help other States acquire such weapons. The CWC foresees time-bound chemical disarmament. The deadlines for destruction for early entrants to the CWC are provided in the treaty. For late entrants, the Conference of States Parties intervenes to set destruction deadlines. One of the unique features of the CWC is thus the regime for verifying destruction of chemical weapons. But how can you design a system for verification at military sites, while protecting military restricted information? What degree of assurance is considered sufficient in such circumstances? How do you divide the verification costs? How do you deal with production capability and initial declarations of existing stockpiles? The founders of the CWC had to address these and other challenges in designing the treaty. Further refinement of the verification system has followed since the treaty opened for signature in 1993 and since inspection work was initiated following entry-into-force of the treaty in 1997. Most of this work concerns destruction at the two large possessor States, Russia and the United States. Perhaps some of the lessons learned from the OPCW experience may be instructive in a future verification regime for nuclear weapons. (author)

  20. Perspectives on barriers and facilitators to minority recruitment for clinical trials among cancer center leaders, investigators, research staff, and referring clinicians: enhancing minority participation in clinical trials (EMPaCT).

    Science.gov (United States)

    Durant, Raegan W; Wenzel, Jennifer A; Scarinci, Isabel C; Paterniti, Debora A; Fouad, Mona N; Hurd, Thelma C; Martin, Michelle Y

    2014-04-01

    The study of disparities in minority recruitment to cancer clinical trials has focused primarily on inquiries among minority populations. Yet very little is known about the perceptions of individuals actively involved in minority recruitment to clinical trials within cancer centers. Therefore, the authors assessed the perspectives of cancer center clinical and research personnel on barriers and facilitators to minority recruitment. In total, 91 qualitative interviews were conducted at 5 US cancer centers among 4 stakeholder groups: cancer center leaders, principal investigators, research staff, and referring clinicians. All interviews were recorded and transcribed. Qualitative analyses of response data was focused on identifying prominent themes related to barriers and facilitators to minority recruitment. The perspectives of the 4 stakeholder groups were largely overlapping with some variations based on their unique roles in minority recruitment. Four prominent themes were identified: 1) racial and ethnic minorities are influenced by varying degrees of skepticism related to trial participation, 2) potential minority participants often face multilevel barriers that preclude them from being offered an opportunity to participate in a clinical trial, 3) facilitators at both the institutional and participant level potentially encourage minority recruitment, and 4) variation between internal and external trial referral procedures may limit clinical trial opportunities for racial and ethnic minorities. Multilevel approaches are needed to address barriers and optimize facilitators within cancer centers to enhance minority recruitment for cancer clinical trials. © 2014 American Cancer Society.

  1. Can Facebook Be Used for Research? Experiences Using Facebook to Recruit Pregnant Women for a Randomized Controlled Trial

    Science.gov (United States)

    Adam, Laura M; Manca, Donna P

    2016-01-01

    Background Recruitment is often a difficult and costly part of any human research study. Social media and other emerging means of mass communication hold promise as means to complement traditional strategies used for recruiting participants because they can reach a large number of people in a short amount of time. With the ability to target a specified audience, paid Facebook advertisements have potential to reach future research participants of a specific demographic. This paper describes the experiences of a randomized controlled trial in Edmonton, Alberta, attempting to recruit healthy pregnant women between 8 and 20 weeks’ gestation for participation in a prenatal study. Various traditional recruitment approaches, in addition to paid Facebook advertisements were trialed. Objective To evaluate the effectiveness of paid advertisements on Facebook as a platform for recruiting pregnant women to a randomized controlled trial in comparison with traditional recruitment approaches. Methods Recruitment using traditional approaches occurred for 7 months, whereas Facebook advertisements ran for a total of 26 days. Interested women were prompted to contact the study staff for a screening call to determine study eligibility. Costs associated with each recruitment approach were recorded and used to calculate the cost to recruit eligible participants. Performance of Facebook advertisements was monitored using Facebook Ads Manager. Results Of the 115 women included, 39.1% (n=45) of the women who contacted study staff heard about the study through Facebook, whereas 60.9% (n=70) of them heard about it through traditional recruitment approaches. During the 215 days (~7 months) that the traditional approaches were used, the average rate of interest was 0.3 (0.2) women/day, whereas the 26 days of Facebook advertisements resulted in an average rate of interest of 2.8 (1.7) women/day. Facebook advertisements cost Can $506.91 with a cost per eligible participant of Cad $20.28. In

  2. Can simply answering research questions change behaviour? Systematic review and meta analyses of brief alcohol intervention trials.

    Directory of Open Access Journals (Sweden)

    Jim McCambridge

    Full Text Available Participant reports of their own behaviour are critical for the provision and evaluation of behavioural interventions. Recent developments in brief alcohol intervention trials provide an opportunity to evaluate longstanding concerns that answering questions on behaviour as part of research assessments may inadvertently influence it and produce bias. The study objective was to evaluate the size and nature of effects observed in randomized manipulations of the effects of answering questions on drinking behaviour in brief intervention trials.Multiple methods were used to identify primary studies. Between-group differences in total weekly alcohol consumption, quantity per drinking day and AUDIT scores were evaluated in random effects meta-analyses. Ten trials were included in this review, of which two did not provide findings for quantitative study, in which three outcomes were evaluated. Between-group differences were of the magnitude of 13.7 (-0.17 to 27.6 grams of alcohol per week (approximately 1.5 U.K. units or 1 standard U.S. drink and 1 point (0.1 to 1.9 in AUDIT score. There was no difference in quantity per drinking day.Answering questions on drinking in brief intervention trials appears to alter subsequent self-reported behaviour. This potentially generates bias by exposing non-intervention control groups to an integral component of the intervention. The effects of brief alcohol interventions may thus have been consistently under-estimated. These findings are relevant to evaluations of any interventions to alter behaviours which involve participant self-report.

  3. CASL Verification and Validation Plan

    Energy Technology Data Exchange (ETDEWEB)

    Mousseau, Vincent Andrew [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States); Dinh, Nam [North Carolina State Univ., Raleigh, NC (United States)

    2016-06-30

    This report documents the Consortium for Advanced Simulation of LWRs (CASL) verification and validation plan. The document builds upon input from CASL subject matter experts, most notably the CASL Challenge Problem Product Integrators, CASL Focus Area leaders, and CASL code development and assessment teams. This document will be a living document that will track progress on CASL to do verification and validation for both the CASL codes (including MPACT, CTF, BISON, MAMBA) and for the CASL challenge problems (CIPS, PCI, DNB). The CASL codes and the CASL challenge problems are at differing levels of maturity with respect to validation and verification. The gap analysis will summarize additional work that needs to be done. Additional VVUQ work will be done as resources permit. This report is prepared for the Department of Energy’s (DOE’s) CASL program in support of milestone CASL.P13.02.

  4. Technical challenges for dismantlement verification

    International Nuclear Information System (INIS)

    Olinger, C.T.; Stanbro, W.D.; Johnston, R.G.; Nakhleh, C.W.; Dreicer, J.S.

    1997-01-01

    In preparation for future nuclear arms reduction treaties, including any potential successor treaties to START I and II, the authors have been examining possible methods for bilateral warhead dismantlement verification. Warhead dismantlement verification raises significant challenges in the political, legal, and technical arenas. This discussion will focus on the technical issues raised by warhead arms controls. Technical complications arise from several sources. These will be discussed under the headings of warhead authentication, chain-of-custody, dismantlement verification, non-nuclear component tracking, component monitoring, and irreversibility. The authors will discuss possible technical options to address these challenges as applied to a generic dismantlement and disposition process, in the process identifying limitations and vulnerabilities. They expect that these considerations will play a large role in any future arms reduction effort and, therefore, should be addressed in a timely fashion

  5. Verification of Space Weather Forecasts using Terrestrial Weather Approaches

    Science.gov (United States)

    Henley, E.; Murray, S.; Pope, E.; Stephenson, D.; Sharpe, M.; Bingham, S.; Jackson, D.

    2015-12-01

    The Met Office Space Weather Operations Centre (MOSWOC) provides a range of 24/7 operational space weather forecasts, alerts, and warnings, which provide valuable information on space weather that can degrade electricity grids, radio communications, and satellite electronics. Forecasts issued include arrival times of coronal mass ejections (CMEs), and probabilistic forecasts for flares, geomagnetic storm indices, and energetic particle fluxes and fluences. These forecasts are produced twice daily using a combination of output from models such as Enlil, near-real-time observations, and forecaster experience. Verification of forecasts is crucial for users, researchers, and forecasters to understand the strengths and limitations of forecasters, and to assess forecaster added value. To this end, the Met Office (in collaboration with Exeter University) has been adapting verification techniques from terrestrial weather, and has been working closely with the International Space Environment Service (ISES) to standardise verification procedures. We will present the results of part of this work, analysing forecast and observed CME arrival times, assessing skill using 2x2 contingency tables. These MOSWOC forecasts can be objectively compared to those produced by the NASA Community Coordinated Modelling Center - a useful benchmark. This approach cannot be taken for the other forecasts, as they are probabilistic and categorical (e.g., geomagnetic storm forecasts give probabilities of exceeding levels from minor to extreme). We will present appropriate verification techniques being developed to address these forecasts, such as rank probability skill score, and comparing forecasts against climatology and persistence benchmarks. As part of this, we will outline the use of discrete time Markov chains to assess and improve the performance of our geomagnetic storm forecasts. We will also discuss work to adapt a terrestrial verification visualisation system to space weather, to help

  6. Utterance Verification for Text-Dependent Speaker Recognition

    DEFF Research Database (Denmark)

    Kinnunen, Tomi; Sahidullah, Md; Kukanov, Ivan

    2016-01-01

    Text-dependent automatic speaker verification naturally calls for the simultaneous verification of speaker identity and spoken content. These two tasks can be achieved with automatic speaker verification (ASV) and utterance verification (UV) technologies. While both have been addressed previously...

  7. Projected Impact of Compositional Verification on Current and Future Aviation Safety Risk

    Science.gov (United States)

    Reveley, Mary S.; Withrow, Colleen A.; Leone, Karen M.; Jones, Sharon M.

    2014-01-01

    The projected impact of compositional verification research conducted by the National Aeronautic and Space Administration System-Wide Safety and Assurance Technologies on aviation safety risk was assessed. Software and compositional verification was described. Traditional verification techniques have two major problems: testing at the prototype stage where error discovery can be quite costly and the inability to test for all potential interactions leaving some errors undetected until used by the end user. Increasingly complex and nondeterministic aviation systems are becoming too large for these tools to check and verify. Compositional verification is a "divide and conquer" solution to addressing increasingly larger and more complex systems. A review of compositional verification research being conducted by academia, industry, and Government agencies is provided. Forty-four aviation safety risks in the Biennial NextGen Safety Issues Survey were identified that could be impacted by compositional verification and grouped into five categories: automation design; system complexity; software, flight control, or equipment failure or malfunction; new technology or operations; and verification and validation. One capability, 1 research action, 5 operational improvements, and 13 enablers within the Federal Aviation Administration Joint Planning and Development Office Integrated Work Plan that could be addressed by compositional verification were identified.

  8. A prospective 2-site parallel intervention trial of a research-based film to increase exercise amongst older hemodialysis patients.

    Science.gov (United States)

    Kontos, Pia; Alibhai, Shabbir M H; Miller, Karen-Lee; Brooks, Dina; Colobong, Romeo; Parsons, Trisha; Jassal, Sarbjit Vanita; Thomas, Alison; Binns, Malcolm; Naglie, Gary

    2017-01-26

    Evidence suggests that exercise training for hemodialysis patients positively improves morbidity and mortality outcomes, yet exercise programs remain rare and are not systematically incorporated into care. We developed a research-based film, Fit for Dialysis, designed to introduce, motivate, and sustain exercise for wellness amongst older hemodialysis patients, and exercise counseling and support by nephrologists, nurses, and family caregivers. The objective of this clinical trial is to determine whether and in what ways Fit for Dialysis improves outcomes and influences knowledge/attitudes regarding the importance of exercise for wellness in the context of end-stage renal disease. This 2-site parallel intervention trial will recruit 60 older hemodialysis patients from two urban hospitals. The trial will compare the film + a 16-week exercise program in one hospital, with a 16-week exercise-only program in another hospital. Physical fitness and activity measures will be performed at baseline, 8 and 16 weeks, and 12 weeks after the end of the program. These include the 2-min Walk Test, Grip Strength, Duke Activity Status Index, and the Timed Up-and-Go Test, as well as wearing a pedometer for one week. Throughout the 16-week exercise program, and at 12 weeks after, we will record patients' exercise using the Godin Leisure-time Exercise Questionnaire. Patients will also keep a diary of the exercise that they do at home on non-dialysis days. Qualitative interviews, conducted at baseline, 8, and 16 weeks, will explore the impact of Fit for Dialysis on the knowledge/attitudes of patients, family caregivers, and nephrology staff regarding exercise for wellness, and in what ways the film is effective in educating, motivating, or sustaining patient exercise during dialysis, at home, and in the community. This research will determine for whom Fit for Dialysis is effective, why, and under what conditions. If Fit for Dialysis is proven beneficial to patients, nephrology

  9. Development of a checklist of quality indicators for clinical trials in resource-limited countries: the French National Agency for Research on AIDS and Viral Hepatitis (ANRS) experience.

    Science.gov (United States)

    Hanna, Mina; Minga, Albert; Fao, Paulin; Borand, Laurence; Diouf, Assane; Mben, Jean-Marc; Gad, Rita R; Anglaret, Xavier; Bazin, Brigitte; Chene, Geneviève

    2013-04-01

    Since 1994, the French National Agency for Research on AIDS and Viral Hepatitis (ANRS) has funded research sites in resource-limited countries (RLCs). These sites implement research on human immunodeficiency virus (HIV) infection and Hepatitis C. In parallel, international regulations and recommendations for clinical trials have evolved and proliferated. However, little guidance exists on how these should be interpreted and applied within academic trials and in the context of RLCs. After developing a specific Ethical Charter for research in developing countries in 2002, ANRS developed a set of quality indicators (QIs) as a monitoring tool for assessing compliance to international guidelines. We describe here the development process, QIs adopted, and areas for improvement. In 2008, a group of experts was convened that included a researcher representing each ANRS site (Cote d'Ivoire, Senegal, Cameroun, Burkina Faso, Egypt, and Cambodia). Our structuring interaction development process combined evidence and expert opinion in two nominal group meetings to identify (1) clinical trial processes involved, (2) issues specific to RLCs in terms of Good Clinical Practice (GCP) and the application of ethical recommendations, and (3) checklists of QIs adapted to clinical trials conducted in RLCs. The trial process reviewed and proposed for RLCs was mostly similar to the one produced in wealthier countries. The scheme generated by our work group added two further processes: 'drug management' and 'biological investigations'. Specific issues regarding trial management in RLCs were therefore described for eight trial steps (1) protocol conception and seeking authorizations, (2) participant enrollment and follow-up, (3) site monitoring, (4) drug management, (5) biological investigations, (6) record management, (7) data management, and (8) site closeout. A total of 58 indicators were identified with at least one indicator for each trial process. Some trial activities require further

  10. Ethics of treatment interruption trials in HIV cure research: addressing the conundrum of risk/benefit assessment

    Science.gov (United States)

    Henderson, Gail E; Peay, Holly L; Kroon, Eugene; Cadigan, Rosemary Jean; Meagher, Karen; Jupimai, Thidarat; Gilbertson, Adam; Fisher, Jill; Ormsby, Nuchanart Q; Chomchey, Nitiya; Phanuphak, Nittaya; Ananworanich, Jintanat; Rennie, Stuart

    2018-01-01

    Though antiretroviral therapy is the standard of care for people living with HIV, its treatment limitations, burdens, stigma and costs lead to continued interest in HIV cure research. Early-phase cure trials, particularly those that include analytic treatment interruption (ATI), involve uncertain and potentially high risk, with minimal chance of clinical benefit. Some question whether such trials should be offered, given the risk/benefit imbalance, and whether those who choose to participate are acting rationally. We address these questions through a longitudinal decision-making study nested in a Thai acute HIV research cohort. In-depth interviews revealed central themes about decisions to join. Participants felt they possessed an important identity as members of the acute cohort, viewing their bodies as uniquely suited to both testing and potentially benefiting from HIV cure approaches. While acknowledging risks of ATI, most perceived they were given an opportunity to interrupt treatment, to test their own bodies and increase normalcy in a safe, highly monitored circumstance. They were motivated by potential benefits to themselves, the investigators and larger acute cohort, and others with HIV. They believed their own trial experiences and being able to give back to the community were sufficient to offset participation risks. These decisions were driven by the specific circumstances experienced by our participants. Judging risk/benefit ratios without appreciating these lived experiences can lead to false determinations of irrational decision- making. While this does not minimise vital oversight considerations about risk reduction and protection from harm, it argues for inclusion of a more participant-centered approach. PMID:29127137

  11. Ethics of treatment interruption trials in HIV cure research: addressing the conundrum of risk/benefit assessment.

    Science.gov (United States)

    Henderson, Gail E; Peay, Holly L; Kroon, Eugene; Cadigan, Rosemary Jean; Meagher, Karen; Jupimai, Thidarat; Gilbertson, Adam; Fisher, Jill; Ormsby, Nuchanart Q; Chomchey, Nitiya; Phanuphak, Nittaya; Ananworanich, Jintanat; Rennie, Stuart

    2018-04-01

    Though antiretroviral therapy is the standard of care for people living with HIV, its treatment limitations, burdens, stigma and costs lead to continued interest in HIV cure research. Early-phase cure trials, particularly those that include analytic treatment interruption (ATI), involve uncertain and potentially high risk, with minimal chance of clinical benefit. Some question whether such trials should be offered, given the risk/benefit imbalance, and whether those who choose to participate are acting rationally. We address these questions through a longitudinal decision-making study nested in a Thai acute HIV research cohort.In-depth interviews revealed central themes about decisions to join. Participants felt they possessed an important identity as members of the acute cohort, viewing their bodies as uniquely suited to both testing and potentially benefiting from HIV cure approaches. While acknowledging risks of ATI, most perceived they were given an opportunity to interrupt treatment, to test their own bodies and increase normalcy in a safe, highly monitored circumstance. They were motivated by potential benefits to themselves, the investigators and larger acute cohort, and others with HIV. They believed their own trial experiences and being able to give back to the community were sufficient to offset participation risks.These decisions were driven by the specific circumstances experienced by our participants. Judging risk/benefit ratios without appreciating these lived experiences can lead to false determinations of irrational decision- making. While this does not minimise vital oversight considerations about risk reduction and protection from harm, it argues for inclusion of a more participant-centered approach. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  12. Formal Verification of Continuous Systems

    DEFF Research Database (Denmark)

    Sloth, Christoffer

    2012-01-01

    and the verification procedures should be algorithmically synthesizable. Autonomous control plays an important role in many safety-critical systems. This implies that a malfunction in the control system can have catastrophic consequences, e.g., in space applications where a design flaw can result in large economic...... losses. Furthermore, a malfunction in the control system of a surgical robot may cause death of patients. The previous examples involve complex systems that are required to operate according to complex specifications. The systems cannot be formally verified by modern verification techniques, due...

  13. Biometric Technologies and Verification Systems

    CERN Document Server

    Vacca, John R

    2007-01-01

    Biometric Technologies and Verification Systems is organized into nine parts composed of 30 chapters, including an extensive glossary of biometric terms and acronyms. It discusses the current state-of-the-art in biometric verification/authentication, identification and system design principles. It also provides a step-by-step discussion of how biometrics works; how biometric data in human beings can be collected and analyzed in a number of ways; how biometrics are currently being used as a method of personal identification in which people are recognized by their own unique corporal or behavior

  14. IMRT plan verification in radiotherapy

    International Nuclear Information System (INIS)

    Vlk, P.

    2006-01-01

    This article describes the procedure for verification of IMRT (Intensity modulated radiation therapy) plan, which is used in the Oncological Institute of St. Elisabeth in Bratislava. It contains basic description of IMRT technology and developing a deployment plan for IMRT planning system CORVUS 6.0, the device Mimic (Multilammelar intensity modulated collimator) and the overall process of verifying the schedule created. The aim of verification is particularly good control of the functions of MIMIC and evaluate the overall reliability of IMRT planning. (author)

  15. K Basins Field Verification Program

    International Nuclear Information System (INIS)

    Booth, H.W.

    1994-01-01

    The Field Verification Program establishes a uniform and systematic process to ensure that technical information depicted on selected engineering drawings accurately reflects the actual existing physical configuration. This document defines the Field Verification Program necessary to perform the field walkdown and inspection process that identifies the physical configuration of the systems required to support the mission objectives of K Basins. This program is intended to provide an accurate accounting of the actual field configuration by documenting the as-found information on a controlled drawing

  16. Runtime Verification Through Forward Chaining

    Directory of Open Access Journals (Sweden)

    Alan Perotti

    2014-12-01

    Full Text Available In this paper we present a novel rule-based approach for Runtime Verification of FLTL properties over finite but expanding traces. Our system exploits Horn clauses in implication form and relies on a forward chaining-based monitoring algorithm. This approach avoids the branching structure and exponential complexity typical of tableaux-based formulations, creating monitors with a single state and a fixed number of rules. This allows for a fast and scalable tool for Runtime Verification: we present the technical details together with a working implementation.

  17. Does a research article's country of origin affect perception of its quality and relevance? A national trial of US public health researchers.

    Science.gov (United States)

    Harris, M; Macinko, J; Jimenez, G; Mahfoud, M; Anderson, C

    2015-12-30

    The source of research may influence one's interpretation of it in either negative or positive ways, however, there are no robust experiments to determine how source impacts on one's judgment of the research article. We determine the impact of source on respondents' assessment of the quality and relevance of selected research abstracts. Web-based survey design using four healthcare research abstracts previously published and included in Cochrane Reviews. All Council on the Education of Public Health-accredited Schools and Programmes of Public Health in the USA. 899 core faculty members (full, associate and assistant professors) Each of the four abstracts appeared with a high-income source half of the time, and low-income source half of the time. Participants each reviewed the same four abstracts, but were randomly allocated to receive two abstracts with high-income source, and two abstracts with low-income source, allowing for within-abstract comparison of quality and relevance Within-abstract comparison of participants' rating scores on two measures--strength of the evidence, and likelihood of referral to a peer (1-10 rating scale). OR was calculated using a generalised ordered logit model adjusting for sociodemographic covariates. Participants who received high income country source abstracts were equal in all known characteristics to the participants who received the abstracts with low income country sources. For one of the four abstracts (a randomised, controlled trial of a pharmaceutical intervention), likelihood of referral to a peer was greater if the source was a high income country (OR 1.28, 1.02 to 1.62, pincome source in their rating of research abstracts. More research may be needed to explore how the origin of a research article may lead to stereotype activation and application in research evaluation. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  18. Ethics in research: from science fairs to clinical trials, the same golden rules apply

    CSIR Research Space (South Africa)

    Wright, C

    2011-07-01

    Full Text Available opinion and not causing anyone physical harm. Similar ?golden rules? apply when you do research and these are called research ethics. When you decide to do a research project that involves humans or animals, whether you are at school, at university... or a professor, there are important steps and rules that you need to follow. Why? Most importantly the steps and rules are there to protect you, the researcher, from making a mistake that may harm a person or an animal. There are important...

  19. The Phase I/II BNCT Trials at the Brookhaven medical research reactor: Critical considerations

    International Nuclear Information System (INIS)

    Diaz, A.Z.

    2001-01-01

    A phase I/II clinical trial of boronophenylalanine-fructose (BPA-F) mediated boron neutron capture therapy (BNCT) for Glioblastoma Multiforme (GBM) was initiated at Brookhaven National Laboratory (BNL) in 1994. Many critical issues were considered during the design of the first of many sequential dose escalation protocols. These critical issues included patient selection criteria, boron delivery agent, dose limits to the normal brain, dose escalation schemes for both neutron exposure and boron dose, and fractionation. As the clinical protocols progressed and evaluation of the tolerance of the central nervous system (CNS) to BPA-mediated BNCT at the BMRR continued new specifications were adopted. Clinical data reflecting the progression of the protocols will be presented to illustrate the steps taken and the reasons behind their adoption. (author)

  20. Research protocol for a randomized controlled trial of the health effects of volunteering for seniors.

    Science.gov (United States)

    Pettigrew, Simone; Jongenelis, Michelle; Newton, Robert U; Warburton, Jeni; Jackson, Ben

    2015-06-04

    A growing evidence base demonstrates that interventions that focus on participation in physical and social activities can assist in preventing and treating both physical and mental health problems. In addition, there is some evidence that engaging in volunteering activities can provide beneficial social, physical, psychological, and cognitive outcomes for older people. This study will use a randomized controlled trial approach to investigate the potential for interventions involving volunteer activities to produce positive physical and psychological outcomes for older people, thereby contributing to the limited evidence relating to the potential for volunteering to provide multiple health effects. This randomized controlled trial will involve 400 retired/non-employed individuals in good health aged 60+ years living in the metropolitan area in Perth, Western Australia. Participants will be recruited from the Perth metropolitan area using a variety of recruitment methods to achieve a diverse sample in terms of age, gender, and socioeconomic status. Consenting and eligible participants will be randomly assigned to an intervention (n = 200) or control group (n = 200). Those in the intervention group will be asked to engage in a minimum 60 min of volunteer activities per week for a period of 6 months, while those in the control group will be asked to maintain their existing lifestyle or take on new activities as they see fit. Physical and psychological outcomes will be assessed. Primary physical outcomes will include physical activity and sedentary time (measured using pedometers and Actigraph monitors) and physical health (measured using a battery of physical functioning tests, resting heart rate, blood pressure, BMI, and girth). Primary psychological outcomes will include psychological well-being, depression, self-esteem, and quality of life (measured using the Warwick-Edinburgh Mental Well-Being Scale, Center for Epidemiologic Studies Depression Scale, the

  1. Refining the definition of mandibular osteoradionecrosis in clinical trials: The cancer research UK HOPON trial (Hyperbaric Oxygen for the Prevention of Osteoradionecrosis).

    Science.gov (United States)

    Shaw, Richard; Tesfaye, Binyam; Bickerstaff, Matt; Silcocks, Paul; Butterworth, Christopher

    2017-01-01

    Mandibular osteoradionecrosis (ORN) is a common and serious complication of head and neck radiotherapy for which there is little reliable evidence for prevention or treatment. The diagnosis and classification of ORN have been inconsistently and imprecisely defined, even in clinical trials. A systematic review of diagnosis and classifications of ORN with specific focus on clinical trials is presented. The most suitable classification was evaluated for consistency using blinded independent review of outcome data (clinical photographs and radiographs) in the HOPON trial. Of 16 ORN classifications found, only one (Notani) appeared suitable as an endpoint in clinical trials. Clinical records of 217 timepoints were analysed amongst 94 randomised patients in the HOPON trial. The only inconsistency in classification arose where minor bone spicules (MBS) were apparent, which occurred in 19% of patients. Some trial investigators judged MBS as clinically unimportant and not reflecting ORN, others classified as ORN based on rigid definitions in common clinical use. When MBS was added as a distinct category to the Notani classification this ambiguity was resolved and agreement between observers was achieved. Most definitions and clinical classifications are based on retrospective case series and may be unsuitable for prospective interventional trials of ORN prevention or treatment. When ORN is used as a primary or secondary outcome in prospective clinical trials, the use of Notani classification with the additional category of MBS is recommended as it avoids subjectivity and enhances reliability and consistency of reporting. Copyright © 2016 Elsevier Ltd. All rights reserved.

  2. Randomised controlled trials of homeopathy in humans: characterising the research journal literature for systematic review.

    Science.gov (United States)

    Mathie, Robert T; Hacke, Daniela; Clausen, Jürgen; Nicolai, Ton; Riley, David S; Fisher, Peter

    2013-01-01

    A new programme of systematic reviews of randomised controlled trials (RCTs) in homeopathy will distinguish important attributes of RCT records, including: placebo controlled versus other-than-placebo (OTP) controlled; individualised versus non-individualised homeopathy; peer-reviewed (PR) versus non peer-reviewed (NPR) sources. (a) To outline the methods used to search and categorise the RCT literature; (b) to report details of the records retrieved; (c) to compare our retrieved records with those reported in two previous systematic reviews (Linde et al., 1997; Shang et al., 2005). Ten major electronic databases were searched for records published up to the end of 2011. A record was accepted for subsequent systematic review if it was a substantive report of a clinical trial of homeopathic treatment or prophylaxis in humans, randomised and controlled, and published in a PR or NPR journal. 489 records were potentially eligible: 226 were rejected as non-journal, minor or repeat publications, or lacking randomisation and/or controls and/or a 'homeopathic' intervention; 263 (164 PR, 99 NPR) were acceptable for systematic review. The 263 accepted records comprised 217 (137 PR, 80 NPR) placebo-controlled RCTs, of which 121 were included by, 66 were published after, and 30 were potentially eligible for, but not listed by, Linde or Shang. The 137 PR records of placebo-controlled RCTs comprise 41 on individualised homeopathy and 96 on non-individualised homeopathy. Our findings clarify the RCT literature in homeopathy. The 263 accepted journal papers will be the basis for our forthcoming programme of systematic reviews. Copyright © 2012 The Faculty of Homeopathy. Published by Elsevier Ltd. All rights reserved.

  3. A Scalable Approach for Hardware Semiformal Verification

    OpenAIRE

    Grimm, Tomas; Lettnin, Djones; Hübner, Michael

    2018-01-01

    The current verification flow of complex systems uses different engines synergistically: virtual prototyping, formal verification, simulation, emulation and FPGA prototyping. However, none is able to verify a complete architecture. Furthermore, hybrid approaches aiming at complete verification use techniques that lower the overall complexity by increasing the abstraction level. This work focuses on the verification of complex systems at the RT level to handle the hardware peculiarities. Our r...

  4. FY 1998 report on the results of the New Sunshine Project - Development of the commercialization technology of the photovoltaic power system. Verification study of the photovoltaic power system - Research on engineering methods for cost effective PV installation; 1998 nendo taiyoko hatsuden system jitsuyoka gijutsu kaihatsu seika hokokusho. Taiyoko hatsuden system no jissho kenkyu (tashu secchi koho no kenkyu kaihatsu)

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1999-03-01

    For the purpose of promoting installations of PV system and making use of the unused space for which a rise in the PV demand equal to that in houses, building roofs, etc. is expected, examination/research for much newer forms of land installation are proceeded with, and evaluation/verification of reliability/durability are conducted of new installation processes using thin film solar cells, adhesives, etc. In this fiscal year, study of the development/verification of low cost floating pedestal was promoted, and at the same time, examinational study of forms of land installation was made. As to the development of low cost floating pedestal, the module type flexible floating pedestal was developed as a small prototype pedestal and tested for installation in a pool. Survey was also carried out of geometry, mooring systems, materials, design conditions, and existing instances of different floats, and measures were studied for the effective use of the floating system. In relation to reliability and durability evaluation of the new installation process, the verification operation of evaluation facilities for various installation processes was continued, and the power generation capacity was made clear in special forms of installation such as installations on vertical/horizontal surfaces. And the study was made of the large area frameless structure, building use double glass structure, and durability of the adhesive/adhesive tape process of thin film solar cells. (NEDO)

  5. FPGA Design and Verification Procedure for Nuclear Power Plant MMIS

    Energy Technology Data Exchange (ETDEWEB)

    Lee, Dongil; Yoo, Kawnwoo; Ryoo, Kwangki [Hanbat National Univ., Daejeon (Korea, Republic of)

    2013-05-15

    In this paper, it is shown that it is possible to ensure reliability by performing the steps of the verification based on the FPGA development methodology, to ensure the safety of application to the NPP MMIS of the FPGA run along the step. Currently, the PLC (Programmable Logic Controller) which is being developed is composed of the FPGA (Field Programmable Gate Array) and CPU (Central Processing Unit). As the importance of the FPGA in the NPP (Nuclear Power Plant) MMIS (Man-Machine Interface System) has been increasing than before, the research on the verification of the FPGA has being more and more concentrated recently.

  6. Challenges in the Verification of Reinforcement Learning Algorithms

    Science.gov (United States)

    Van Wesel, Perry; Goodloe, Alwyn E.

    2017-01-01

    Machine learning (ML) is increasingly being applied to a wide array of domains from search engines to autonomous vehicles. These algorithms, however, are notoriously complex and hard to verify. This work looks at the assumptions underlying machine learning algorithms as well as some of the challenges in trying to verify ML algorithms. Furthermore, we focus on the specific challenges of verifying reinforcement learning algorithms. These are highlighted using a specific example. Ultimately, we do not offer a solution to the complex problem of ML verification, but point out possible approaches for verification and interesting research opportunities.

  7. IDEF method for designing seismic information system in CTBT verification

    International Nuclear Information System (INIS)

    Zheng Xuefeng; Shen Junyi; Jin Ping; Zhang Huimin; Zheng Jiangling; Sun Peng

    2004-01-01

    Seismic information system is of great importance for improving the capability of CTBT verification. A large amount of money has been appropriated for the research in this field in the U.S. and some other countries in recent years. However, designing and developing a seismic information system involves various technologies about complex system design. This paper discusses the IDEF0 method to construct function models and the IDEF1x method to make information models systemically, as well as how they are used in designing seismic information system in CTBT verification. (authors)

  8. Ethical and social implications of microdosing clinical trial (3). Radiological protection of human subjects in research

    International Nuclear Information System (INIS)

    Kurihara, Chieko

    2008-01-01

    Internal irradiation of human subjects in research is discussed. Radiological protection of human subjects in medical research in a framework of radiation protection is surveyed from a viewpoint of general life-ethics and research-ethics. A workshop 'On the internal irradiation of human subjects' to summarize special and systematic knowledge was organized by Research Center for Radiation Protection, National Institute of Radiological Sciences in the beginning of 2008. Activities of this workshop are introduced. Discussion covers also (1) Research ethics and radiation protection, (2) Fundamentals and applications of risk-benefit assessment, (3) Human subjects risk assessment in ICRP recommendation, (4) Mechanism of human subjects internal irradiation assessment, and (5) Present status and future prospects in Japan. (K.Y.)

  9. Impact of the Patient-Reported Outcomes Management Information System (PROMIS) upon the design and operation of multi-center clinical trials: a qualitative research study.

    Science.gov (United States)

    Eisenstein, Eric L; Diener, Lawrence W; Nahm, Meredith; Weinfurt, Kevin P

    2011-12-01

    New technologies may be required to integrate the National Institutes of Health's Patient Reported Outcome Management Information System (PROMIS) into multi-center clinical trials. To better understand this need, we identified likely PROMIS reporting formats, developed a multi-center clinical trial process model, and identified gaps between current capabilities and those necessary for PROMIS. These results were evaluated by key trial constituencies. Issues reported by principal investigators fell into two categories: acceptance by key regulators and the scientific community, and usability for researchers and clinicians. Issues reported by the coordinating center, participating sites, and study subjects were those faced when integrating new technologies into existing clinical trial systems. We then defined elements of a PROMIS Tool Kit required for integrating PROMIS into a multi-center clinical trial environment. The requirements identified in this study serve as a framework for future investigators in the design, development, implementation, and operation of PROMIS Tool Kit technologies.

  10. Likelihood-ratio-based biometric verification

    NARCIS (Netherlands)

    Bazen, A.M.; Veldhuis, Raymond N.J.

    2002-01-01

    This paper presents results on optimal similarity measures for biometric verification based on fixed-length feature vectors. First, we show that the verification of a single user is equivalent to the detection problem, which implies that for single-user verification the likelihood ratio is optimal.

  11. Likelihood Ratio-Based Biometric Verification

    NARCIS (Netherlands)

    Bazen, A.M.; Veldhuis, Raymond N.J.

    The paper presents results on optimal similarity measures for biometric verification based on fixed-length feature vectors. First, we show that the verification of a single user is equivalent to the detection problem, which implies that, for single-user verification, the likelihood ratio is optimal.

  12. Can Facebook Be Used for Research? Experiences Using Facebook to Recruit Pregnant Women for a Randomized Controlled Trial.

    Science.gov (United States)

    Adam, Laura M; Manca, Donna P; Bell, Rhonda C

    2016-09-21

    Recruitment is often a difficult and costly part of any human research study. Social media and other emerging means of mass communication hold promise as means to complement traditional strategies used for recruiting participants because they can reach a large number of people in a short amount of time. With the ability to target a specified audience, paid Facebook advertisements have potential to reach future research participants of a specific demographic. This paper describes the experiences of a randomized controlled trial in Edmonton, Alberta, attempting to recruit healthy pregnant women between 8 and 20 weeks' gestation for participation in a prenatal study. Various traditional recruitment approaches, in addition to paid Facebook advertisements were trialed. To evaluate the effectiveness of paid advertisements on Facebook as a platform for recruiting pregnant women to a randomized controlled trial in comparison with traditional recruitment approaches. Recruitment using traditional approaches occurred for 7 months, whereas Facebook advertisements ran for a total of 26 days. Interested women were prompted to contact the study staff for a screening call to determine study eligibility. Costs associated with each recruitment approach were recorded and used to calculate the cost to recruit eligible participants. Performance of Facebook advertisements was monitored using Facebook Ads Manager. Of the 115 women included, 39.1% (n=45) of the women who contacted study staff heard about the study through Facebook, whereas 60.9% (n=70) of them heard about it through traditional recruitment approaches. During the 215 days (~7 months) that the traditional approaches were used, the average rate of interest was 0.3 (0.2) women/day, whereas the 26 days of Facebook advertisements resulted in an average rate of interest of 2.8 (1.7) women/day. Facebook advertisements cost Can $506.91 with a cost per eligible participant of Cad $20.28. In comparison, the traditional approaches

  13. Automated Verification of Virtualized Infrastructures

    DEFF Research Database (Denmark)

    Bleikertz, Sören; Gross, Thomas; Mödersheim, Sebastian Alexander

    2011-01-01

    Virtualized infrastructures and clouds present new challenges for security analysis and formal verification: they are complex environments that continuously change their shape, and that give rise to non-trivial security goals such as isolation and failure resilience requirements. We present a pla...

  14. Future of monitoring and verification

    International Nuclear Information System (INIS)

    Wagenmakers, H.

    1991-01-01

    The organized verification entrusted to IAEA for the implementation of the NPT, of the Treaty of Tlatelolco and of the Treaty of Rarotonga, reaches reasonable standards. The current dispute with the Democratic People's Republic of Korea about the conclusion of a safeguards agreement with IAEA, by its exceptional nature, underscores rather than undermines the positive judgement to be passed on IAEA's overall performance. The additional task given to the Director General of IAEA under Security Council resolution 687 (1991) regarding Iraq's nuclear-weapons-usable material is particularly challenging. For the purposes of this paper, verification is defined as the process for establishing whether the States parties are complying with an agreement. In the final stage verification may lead into consideration of how to respond to non-compliance. Monitoring is perceived as the first level in the verification system. It is one generic form of collecting information on objects, activities or events and it involves a variety of instruments ranging from communications satellites to television cameras or human inspectors. Monitoring may also be used as a confidence-building measure

  15. Hot cell verification facility update

    International Nuclear Information System (INIS)

    Titzler, P.A.; Moffett, S.D.; Lerch, R.E.

    1985-01-01

    The Hot Cell Verification Facility (HCVF) provides a prototypic hot cell mockup to check equipment for functional and remote operation, and provides actual hands-on training for operators. The facility arrangement is flexible and assists in solving potential problems in a nonradioactive environment. HCVF has been in operation for six years, and the facility is a part of the Hanford Engineering Development Laboratory

  16. Eggspectation : organic egg verification tool

    NARCIS (Netherlands)

    Ruth, van S.M.; Hoogenboom, L.A.P.

    2011-01-01

    In 2009 RIKILT conducted a study on about 2,000 eggs to evaluate three different analytical verification methods: carotenoid profiling, fatty acid profiling and isotope ratio mass spectrometry. The eggs were collected from about 50 Dutch farms. The selection was based on the farms’ location and

  17. Specification and Verification of Hybrid System

    International Nuclear Information System (INIS)

    Widjaja, Belawati H.

    1997-01-01

    Hybrid systems are reactive systems which intermix between two components, discrete components and continuous components. The continuous components are usually called plants, subject to disturbances which cause the state variables of the systems changing continuously by physical laws and/or by the control laws. The discrete components can be digital computers, sensor and actuators controlled by programs. These programs are designed to select, control and supervise the behavior of the continuous components. Specification and verification of hybrid systems has recently become an active area of research in both computer science and control engineering, many papers concerning hybrid system have been published. This paper gives a design methodology for hybrid systems as an example to the specification and verification of hybrid systems. The design methodology is based on the cooperation between two disciplines, control engineering and computer science. The methodology brings into the design of control loops and decision loops. The external behavior of control loops are specified in a notation which is understandable by the two disciplines. The design of control loops which employed theory of differential equation is done by control engineers, and its correctness is also guaranteed analytically or experimentally by control engineers. The decision loops are designed in computing science based on the specifications of control loops. The verification of systems requirements can be done by computing scientists using a formal reasoning mechanism. For illustrating the proposed design, a problem of balancing an inverted pendulum which is a popular experiment device in control theory is considered, and the Mean Value Calculus is chosen as a formal notation for specifying the control loops and designing the decision loops

  18. VEG-01: Veggie Hardware Verification Testing

    Science.gov (United States)

    Massa, Gioia; Newsham, Gary; Hummerick, Mary; Morrow, Robert; Wheeler, Raymond

    2013-01-01

    The Veggie plant/vegetable production system is scheduled to fly on ISS at the end of2013. Since much of the technology associated with Veggie has not been previously tested in microgravity, a hardware validation flight was initiated. This test will allow data to be collected about Veggie hardware functionality on ISS, allow crew interactions to be vetted for future improvements, validate the ability of the hardware to grow and sustain plants, and collect data that will be helpful to future Veggie investigators as they develop their payloads. Additionally, food safety data on the lettuce plants grown will be collected to help support the development of a pathway for the crew to safely consume produce grown on orbit. Significant background research has been performed on the Veggie plant growth system, with early tests focusing on the development of the rooting pillow concept, and the selection of fertilizer, rooting medium and plant species. More recent testing has been conducted to integrate the pillow concept into the Veggie hardware and to ensure that adequate water is provided throughout the growth cycle. Seed sanitation protocols have been established for flight, and hardware sanitation between experiments has been studied. Methods for shipping and storage of rooting pillows and the development of crew procedures and crew training videos for plant activities on-orbit have been established. Science verification testing was conducted and lettuce plants were successfully grown in prototype Veggie hardware, microbial samples were taken, plant were harvested, frozen, stored and later analyzed for microbial growth, nutrients, and A TP levels. An additional verification test, prior to the final payload verification testing, is desired to demonstrate similar growth in the flight hardware and also to test a second set of pillows containing zinnia seeds. Issues with root mat water supply are being resolved, with final testing and flight scheduled for later in 2013.

  19. Association between framing of the research question using the PICOT format and reporting quality of randomized controlled trials

    Directory of Open Access Journals (Sweden)

    Thabane Lehana

    2010-02-01

    Full Text Available Abstract Background Experts recommend formulating a structured research question to guide the research design. However, the basis for this recommendation has not been formally evaluated. The aim of this study was to examine if a structured research question using the PICOT (Population, Intervention, Comparator, Outcome, Time-frame format is associated with a better reporting quality of randomized controlled trials (RCTs. Methods We evaluated 89 RCTs reports published in three endocrinology journals in 2005 and 2006, the quality of reporting of which was assessed in a previous study. We examined whether the reports stated each of the five elements of a structured research question: population, intervention, comparator, outcome and time-frame. A PICOT score was created with a possible score between 0 and 5. Outcomes were: 1 a 14-point overall reporting quality score (OQS based on the Consolidated Standards for Reporting Trials; and 2 a 3-point key score (KS, based on allocation concealment, blinding and use of intention-to-treat analysis. We conducted multivariable regression analyses using generalized estimating equations to determine if a higher PICOT score or the use of a structured research question were independently associated with a better reporting quality. Journal of publication, funding source and sample size were identified as factors associated with OQS in our previous report on this dataset, and therefore included in the model. Results A higher PICOT score was independently associated with OQS (incidence rate ratio (IRR = 1.021, 95% CI: 1.012 to 1.029 and KS (IRR = 1.142, 95% CI: 1.079 to 1.210. A structured research question was present in 33.7% of the reports and it was associated with a better OQS (IRR = 1.095, 95% CI 1.059-1.132 and KS (IRR = 1.530, 95% CI 1.311-1.786. Conclusions Better framing of the research question using the PICOT format is independently associated with better overall reporting quality - although the effect

  20. The TrialsTracker: Automated ongoing monitoring of failure to share clinical trial results by all major companies and research institutions.

    Science.gov (United States)

    Powell-Smith, Anna; Goldacre, Ben

    2016-01-01

    Background : Failure to publish trial results is a prevalent ethical breach with a negative impact on patient care. Audit is an important tool for quality improvement. We set out to produce an online resource that automatically identifies the sponsors with the best and worst record for failing to share trial results. Methods: A tool was produced that identifies all completed trials from clinicaltrials.gov, searches for results in the clinicaltrials.gov registry and on PubMed, and presents summary statistics for each sponsor online. Results : The TrialsTracker tool is now available. Results are consistent with previous publication bias cohort studies using manual searches. The prevalence of missing studies is presented for various classes of sponsor. All code and data is shared. Discussion: We have designed, built, and launched an easily accessible online service, the TrialsTracker, that identifies sponsors who have failed in their duty to make results of clinical trials available, and which can be maintained at low cost. Sponsors who wish to improve their performance metrics in this tool can do so by publishing the results of their trials.

  1. Assistant professor Andrea Wittenborn, research team conduct clinical trial to treat couples' depression, marital problems

    OpenAIRE

    Micale, Barbara L.

    2010-01-01

    Andrea Wittenborn, assistant professor, human development, is heading a research team conducting the Strengthening Bonds Couples Therapy Study to treat depression and marital problems (dyadic distress) in married/committed couple relationships.

  2. Variability in research ethics review of cluster randomized trials: a scenario-based survey in three countries

    Science.gov (United States)

    2014-01-01

    Background Cluster randomized trials (CRTs) present unique ethical challenges. In the absence of a uniform standard for their ethical design and conduct, problems such as variability in procedures and requirements by different research ethics committees will persist. We aimed to assess the need for ethics guidelines for CRTs among research ethics chairs internationally, investigate variability in procedures for research ethics review of CRTs within and among countries, and elicit research ethics chairs’ perspectives on specific ethical issues in CRTs, including the identification of research subjects. The proper identification of research subjects is a necessary requirement in the research ethics review process, to help ensure, on the one hand, that subjects are protected from harm and exploitation, and on the other, that reviews of CRTs are completed efficiently. Methods A web-based survey with closed- and open-ended questions was administered to research ethics chairs in Canada, the United States, and the United Kingdom. The survey presented three scenarios of CRTs involving cluster-level, professional-level, and individual-level interventions. For each scenario, a series of questions was posed with respect to the type of review required (full, expedited, or no review) and the identification of research subjects at cluster and individual levels. Results A total of 189 (35%) of 542 chairs responded. Overall, 144 (84%, 95% CI 79 to 90%) agreed or strongly agreed that there is a need for ethics guidelines for CRTs and 158 (92%, 95% CI 88 to 96%) agreed or strongly agreed that research ethics committees could be better informed about distinct ethical issues surrounding CRTs. There was considerable variability among research ethics chairs with respect to the type of review required, as well as the identification of research subjects. The cluster-cluster and professional-cluster scenarios produced the most disagreement. Conclusions Research ethics committees

  3. An Unattended Verification Station for UF6 Cylinders: Development Status

    International Nuclear Information System (INIS)

    Smith, E.; McDonald, B.; Miller, K.; Garner, J.; March-Leuba, J.; Poland, R.

    2015-01-01

    In recent years, the International Atomic Energy Agency (IAEA) has pursued innovative techniques and an integrated suite of safeguards measures to address the verification challenges posed by advanced centrifuge technologies and the growth in separative work unit capacity at modern centrifuge enrichment plants. These measures would include permanently installed, unattended instruments capable of performing the routine and repetitive measurements previously performed by inspectors. Among the unattended instruments currently being explored by the IAEA is an Unattended Cylinder Verification Stations (UCVS) that could provide independent verification of the declared relative enrichment, U-235 mass and total uranium mass of all declared cylinders moving through the plant, as well as the application and verification of a ''Non-destructive Assay Fingerprint'' to preserve verification knowledge on the contents of each cylinder throughout its life in the facility. As IAEA's vision for a UCVS has evolved, Pacific Northwest National Laboratory (PNNL) and Los Alamos National Laboratory have been developing and testing candidate non-destructive assay (NDA) methods for inclusion in a UCVS. Modeling and multiple field campaigns have indicated that these methods are capable of assaying relative cylinder enrichment with a precision comparable to or substantially better than today's high-resolution handheld devices, without the need for manual wall-thickness corrections. In addition, the methods interrogate the full volume of the cylinder, thereby offering the IAEA a new capability to assay the absolute U-235 mass in the cylinder, and much-improved sensitivity to substituted or removed material. Building on this prior work, and under the auspices of the United States Support Programme to the IAEA, a UCVS field prototype is being developed and tested. This paper provides an overview of: a) hardware and software design of the prototypes, b) preparation

  4. The second Symptom Management Research Trial in Oncology (SMaRT Oncology-2): a randomised trial to determine the effectiveness and cost-effectiveness of adding a complex intervention for major depressive disorder to usual care for cancer patients.

    Science.gov (United States)

    Walker, Jane; Cassidy, Jim; Sharpe, Michael

    2009-03-30

    Depression Care for People with Cancer is a complex intervention delivered by specially trained cancer nurses, under the supervision of a psychiatrist. It is given as a supplement to the usual care for depression, which patients receive from their general practitioner and cancer service. In a 'proof of concept' trial (Symptom Management Research Trials in Oncology-1) Depression Care for People with Cancer improved depression more than usual care alone. The second Symptom Management Research Trial in Oncology (SMaRT Oncology-2 Trial) will test its effectiveness and cost-effectiveness in a 'real world' setting. A two arm parallel group multi-centre randomised controlled trial. TRIAL PROCEDURES: 500 patients will be recruited through established systematic Symptom Monitoring Services, which screen patients for depression. Patients will have: a diagnosis of cancer (of various types); an estimated life expectancy of twelve months or more and a diagnosis of Major Depressive Disorder. Patients will be randomised to usual care or usual care plus Depression Care for People with Cancer. Randomisation will be carried out by telephoning a secure computerised central randomisation system or by using a secure web interface. The primary outcome measure is 'treatment response' measured at 24 week outcome data collection. 'Treatment response' will be defined as a reduction of 50% or more in the patient's baseline depression score, measured using the 20-item Symptom Checklist (SCL-20D). Secondary outcomes include remission of major depressive disorder, depression severity and patients' self-rated improvement of depression. Current controlled trials ISRCTN40568538 TRIAL HYPOTHESES: (1) Depression Care for People with Cancer as a supplement to usual care will be more effective than usual care alone in achieving a 50% reduction in baseline SCL-20D score at 24 weeks. (2) Depression Care for People with Cancer as a supplement to usual care will cost more than usual care alone but will be

  5. Automated collection of medical images for research from heterogeneous systems: trials and tribulations

    Science.gov (United States)

    Patel, M. N.; Looney, P.; Young, K.; Halling-Brown, M. D.

    2014-03-01

    Radiological imaging is fundamental within the healthcare industry and has become routinely adopted for diagnosis, disease monitoring and treatment planning. Over the past two decades both diagnostic and therapeutic imaging have undergone a rapid growth, the ability to be able to harness this large influx of medical images can provide an essential resource for research and training. Traditionally, the systematic collection of medical images for research from heterogeneous sites has not been commonplace within the NHS and is fraught with challenges including; data acquisition, storage, secure transfer and correct anonymisation. Here, we describe a semi-automated system, which comprehensively oversees the collection of both unprocessed and processed medical images from acquisition to a centralised database. The provision of unprocessed images within our repository enables a multitude of potential research possibilities that utilise the images. Furthermore, we have developed systems and software to integrate these data with their associated clinical data and annotations providing a centralised dataset for research. Currently we regularly collect digital mammography images from two sites and partially collect from a further three, with efforts to expand into other modalities and sites currently ongoing. At present we have collected 34,014 2D images from 2623 individuals. In this paper we describe our medical image collection system for research and discuss the wide spectrum of challenges faced during the design and implementation of such systems.

  6. Recruitment of patients into head and neck clinical trials: acceptability of studies to patients from perspective of the research team.

    Science.gov (United States)

    Ho, M W; Pick, A S; Sutton, D N; Dyker, K; Cardale, K; Gilbert, K; Johnson, J; Quantrill, J; McCaul, J A

    2018-05-01

    We reviewed longitudinal recruitment data to assess recruitment into head and neck cancer trials, and to identify factors that could influence this and affect their acceptability to patients. We retrieved data from the prospective computerised database (2009-2016) to measure acceptability to patients using the recruitment:screening ratio, and compared observational with interventional studies, single specialty (or site) with multispecialty (or site) studies, and "step-up" randomisation with "non-inferiority" randomisation designs. A total of 1283 patients were screened and 583 recruited. The recruitment:screening ratio for all National Institute for Health Research (NIHR) portfolio studies combined was 0.47 (486/1133). Studies that involved treatment by several specialties or at several sites had a significantly adverse impact on acceptability (p=0.01). Recruitment into non-inferiority randomised controlled studies was lower than that into step-up randomised studies (p=0.06). The complexity of a study's design did not compromise recruitment. Treatment across several specialties or several sites and perceived non-inferiority designs, reduced the acceptability of some trials. Crown Copyright © 2018. Published by Elsevier Ltd. All rights reserved.

  7. Cancer patient and survivor research from the cancer information service research consortium: a preview of three large randomized trials and initial lessons learned.

    Science.gov (United States)

    Marcus, Alfred C; Diefenbach, Michael A; Stanton, Annette L; Miller, Suzanne M; Fleisher, Linda; Raich, Peter C; Morra, Marion E; Perocchia, Rosemarie Slevin; Tran, Zung Vu; Bright, Mary Anne

    2013-01-01

    The authors describe 3 large randomized trials from the Cancer Information Service Research Consortium. Three web-based multimedia programs are being tested to help newly diagnosed prostate (Project 1) and breast cancer patients (Project 2) make informed treatment decisions and breast cancer patients prepare for life after treatment (Project 3). Project 3 also tests a telephone callback intervention delivered by a cancer information specialist. All participants receive standard print material specific to each project. Preliminary results from the 2-month follow-up interviews are reported for the initial wave of enrolled participants, most of whom were recruited from the Cancer Information Service (1-800-4-CANCER) telephone information program (Project 1: n =208; Project 2: n =340; Project 3: n =792). Self-reported use of the multimedia program was 51%, 52%, and 67% for Projects 1, 2, and 3, respectively. Self-reported use of the print materials (read all, most, or some) was 90%, 85%, and 83% for Projects 1, 2, and 3, respectively. The callback intervention was completed by 92% of Project 3 participants. Among those using the Cancer Information Service Research Consortium interventions, perceived usefulness and benefit was high, and more than 90% reported that they would recommend them to other cancer patients. The authors present 5 initial lessons learned that may help inform future cancer communications research.

  8. FEFTRA {sup TM} verification. Update 2013

    Energy Technology Data Exchange (ETDEWEB)

    Loefman, J. [VTT Technical Research Centre of Finland, Espoo (Finland); Meszaros, F. [The Relief Lab., Harskut, (Hungary)

    2013-12-15

    FEFTRA is a finite element program package developed at VTT for the analyses of groundwater flow in Posiva's site evaluation programme that seeks a final repository for spent nuclear fuel in Finland. The code is capable of modelling steady-state or transient groundwater flow, solute transport and heat transfer as coupled or separate phenomena. Being a typical research tool used only by its developers, the FEFTRA code lacked long of a competent testing system and precise documentation of the verification of the code. In 2006 a project was launched, in which the objective was to reorganise all the material related to the existing verification cases and place them into the FEFTRA program path under the version-control system. The work also included development of a new testing system, which automatically calculates the selected cases, checks the new results against the old approved results and constructs a summary of the test run. All the existing cases were gathered together, checked and added into the new testing system. The documentation of each case was rewritten with the LATEX document preparation system and added into the testing system in a way that the whole test documentation (this report) could easily be generated in a postscript or pdf-format. The current report is the updated version of the verification report published in 2007. At the moment the report includes mainly the cases related to the testing of the primary result quantities (i.e. hydraulic head, pressure, salinity concentration, temperature). The selected cases, however, represent typical hydrological applications, in which the program package has been and will be employed in the Posiva's site evaluation programme, i.e. the simulations of groundwater flow, solute transport and heat transfer as separate or coupled phenomena. The comparison of the FEFTRA results to the analytical, semianalytical and/or other numerical solutions proves the capability of FEFTRA to simulate such problems

  9. Research and field trials with a blend of ethanol in diesel oil

    Energy Technology Data Exchange (ETDEWEB)

    Egebaeck, K.E. [Autoemission K-E E Consultant, Nykoeping (Sweden)

    1999-03-01

    The aim of this report is to summarize the experiences acquired and data generated during the project named `The mixed fuel project` which was carried out during the years 1993 to 1997. The project was initiated after that some information had been collected in Australia, where a similar project was underway. The Australian project showed some interesting data and within that project an emulsifier had been developed - an emulsifier which has also been used in the Swedish project. In order to avoid a costly development of a method for blending ethanol in diesel oil, a form of co-operation was established between the people involved in Australia and those involved in Sweden. The content of ethanol in diesel oil used in Australia was 15 % and the investigations in Sweden reported further down in this report the ratio 15 % ethanol in MK 1 (an environmentally classified diesel fuel in Sweden) was the best alternative to be used also in Sweden. Twelve reports have been studied and used as references in order to summarize the results and experiences from the project. In order to fulfil the obligations of the project many institutions, private and community companies, consultants and universities in Sweden were involved. In the report presents the main results from the different investigations and field trials with ethanol-diesel fueled vehicles. It can be said that there are no technical problems connected to the use of ethanol-diesel fuel but the most serious drawback is the cost of the fuel. There is also a need for further development of the technology of making a homogenous emulsion of ethanol in diesel oil at a reasonable cost. The main advantage of using the mixed fuel is that the emission of particles is considerably reduced. The emission of CO{sub 2} is also reduced when the ethanol is produced from biomass using an environmentally friendly method 17 refs, 22 figs, 22 tabs

  10. Clinical Trials

    Medline Plus

    Full Text Available ... medicines, and how well they work. The U.S. Food and Drug Administration (FDA) oversees these ... trials are a key research tool for advancing medical knowledge and patient care. ...

  11. Clinical Trials

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    Full Text Available ... and compare new treatments with other available treatments. Steps To Avoid Bias The researchers doing clinical trials take steps to avoid bias. "Bias" means that human choices ...

  12. Clinical Trials

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    Full Text Available ... materials, and offer advice on research-related issues. Data Safety Monitoring Board Every National Institutes of Health ( ... III clinical trial is required to have a Data and Safety Monitoring Board (DSMB). This board consists ...

  13. Clinical Trials

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    Full Text Available ... final stages of a long and careful research process. The process often begins in a laboratory (lab), where scientists ... part in clinical trials are vital to the process of improving medical care. Many people volunteer because ...

  14. Clinical Trials

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    Full Text Available ... as gene therapy) or vulnerable patients (such as children). A DSMB's role is to review data from a clinical trial for safety problems or differences in results among different groups. The DSMB also reviews research results ...

  15. Clinical Trials

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    Full Text Available ... clinical trial. IRB members are doctors, statisticians, and community members. The IRB's purpose is to ensure that ... lung, and blood disorders. By engaging the research community and a broad group of stakeholders and advisory ...

  16. Clinical Trials

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    Full Text Available ... successfully developed and evaluated to fill an important gap in information and education for parents, clinicians, researchers, ... gathered can help others and add to scientific knowledge. People who take part in clinical trials are ...

  17. Clinical Trials

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    Full Text Available ... Masking, or "blinding," helps avoid bias. For this reason, researchers also may not be told which treatments ... from a study at any time, for any reason. Also, during the trial, you have the right ...

  18. Clinical Trials

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    Full Text Available ... get special protection as research subjects. Almost always, parents must give legal consent for their child to ... trial's potential risks are greater than minimal, both parents must give permission for their child to enroll. ...

  19. Clinical Trials

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    Full Text Available ... results. Clinical trials are one of the final stages of a long and careful research process. The ... a patient's age and gender, the type and stage of disease, and whether the patient has had ...

  20. Clinical Trials

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    Full Text Available ... A-Z Clinical Trials Publications and Resources Health Education and Awareness The Science Science Home Blood Disorders ... to fill an important gap in information and education for parents, clinicians, researchers, children, and the general ...

  1. Clinical Trials

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    Full Text Available ... work best for certain illnesses or groups of people. Clinical trials produce the best data available for ... or animals doesn't always work well in people. Thus, research in humans is needed. For safety ...

  2. Clinical Trials

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    Full Text Available ... harm. In later phases of clinical trials, researchers learn more about the new approach's risks and benefits. ... explore whether surgery or other medical treatments produce better results for certain illnesses or groups of people; ...

  3. Clinical Trials

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    Full Text Available ... patients. Usually, a computer program makes the group assignments. Masking The term "masking" refers to not telling ... questions to ask your doctor and the research staff, go to "How Do Clinical Trials Protect Participants?" ...

  4. Clinical Trials

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    Full Text Available ... questions to ask your doctor and the research staff, go to "How Do Clinical Trials Protect Participants?" ... in Bethesda, Maryland. The physicians, nurses, scientists and staff of the NHLBI encourage you to explore NIH ...

  5. Clinical Trials

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    Full Text Available ... and evaluated to fill an important gap in information and education for parents, clinicians, researchers, children, and the general public. What to Expect During a clinical trial, ...

  6. Clinical Trials

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    Full Text Available ... records can quickly show this information if safety issues arise. Participation and Eligibility Each clinical trial defines ... and materials, and offer advice on research-related issues. Data Safety Monitoring Board Every National Institutes of ...

  7. Clinical Trials

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    Full Text Available ... that the participants' rights are protected. The IRB reviews the trial's protocol before the study begins. An IRB will only approve research that deals with medically important questions ...

  8. Clinical Trials

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    Full Text Available ... as the U.S. Departments of Defense and Veterans Affairs; private companies; universities; and nonprofit organizations. NIH Institutes ... for parents, clinicians, researchers, children, and the general public. What to Expect During a clinical trial, doctors, ...

  9. Clinical Trials

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    Full Text Available ... Precision Medicine Activities Obesity, Nutrition, and Physical Activity Population and Epidemiology Studies Women’s Health All Science A- ... assumed that trial results were valid for other populations as well. Researchers now realize that women and ...

  10. The First Trial of the P Technique in Psychotherapy Research: A Still-Lively Legacy.

    Science.gov (United States)

    Luborsky, Lester

    1995-01-01

    Reexamines a 49-year-old study of P technique applied to a psychotherapy patient with a recurrent physical symptom. Explores dimensions of psychotherapeutic change as well as the context for the recurrent symptom. Illustrates the contributions from applying the P technique to psychotherapy research, to psychosomatic medicine, and to personality…

  11. Clinical trial regulation in Argentina: overview and analysis of regulatory framework, use of existing tools, and researchers' perspectives to identify potential barriers.

    Science.gov (United States)

    White, Lauren; Ortiz, Zulma; Cuervo, Luis G; Reveiz, Ludovic

    2011-11-01

    To review and analyze the regulatory framework of clinical trial registration, use of existing tools (publicly accessible national/international registration databases), and users' perspectives to identify possible barriers to registration compliance by sponsors and researchers in Argentina. Internationally registered trials recruiting patients in Argentina were found through clincialtrials.gov and the International Clinical Trial Registration Platform (ICTRP) and compared with publically available clinical trials registered through the National Administration of Drugs, Foods, and Medical Devices (ANMAT). A questionnaire addressing hypothesized attitudinal, knowledge-related, idiomatic, technical, economic, and regulatory barriers that could discourage or impede registration of clinical trials was developed, and semi-structured, in-depth interviews were conducted with a purposively selected sample of researchers (investigators, sponsors, and monitors) in Argentina. A response rate of 74.3% (n = 29) was achieved, and 27 interviews were ultimately used for analysis. Results suggested that the high proportion of foreign-sponsored or multinational trials (64.8% of all protocols approved by ANMAT from 1994-2006) may contribute to a communication gap between locally based investigators and foreign-based administrative officials. A lack of knowledge about available international registration tools and limited awareness of the importance of registration were also identified as limiting factors for local investigators and sponsors. To increase compliance and promote clinical trial registration in Argentina, national health authorities, sponsors, and local investigators could take the following steps: implement a grassroots educational campaign to improve clinical trial regulation, support local investigator-sponsor-initiated clinical trials, and/or encourage local and regional scientific journal compliance with standards from the International Committee of Medical Journal

  12. Exploring the experiences of substitute decision-makers with an exception to consent in a paediatric resuscitation randomised controlled trial: study protocol for a qualitative research study

    Science.gov (United States)

    de Laat, Sonya; Schwartz, Lisa

    2016-01-01

    Introduction Prospective informed consent is required for most research involving human participants; however, this is impracticable under some circumstances. The Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS) outlines the requirements for research involving human participants in Canada. The need for an exception to consent (deferred consent) is recognised and endorsed in the TCPS for research in individual medical emergencies; however, little is known about substitute decision-maker (SDM) experiences. A paediatric resuscitation trial (SQUEEZE) (NCT01973907) using an exception to consent process began enrolling at McMaster Children's Hospital in January 2014. This qualitative research study aims to generate new knowledge on SDM experiences with the exception to consent process as implemented in a randomised controlled trial. Methods and analysis The SDMs of children enrolled into the SQUEEZE pilot trial will be the sampling frame from which ethics study participants will be derived. Design: Qualitative research study involving individual interviews and grounded theory methodology. Participants: SDMs for children enrolled into the SQUEEZE pilot trial. Sample size: Up to 25 SDMs. Qualitative methodology: SDMs will be invited to participate in the qualitative ethics study. Interviews with consenting SDMs will be conducted in person or by telephone, taped and professionally transcribed. Participants will be encouraged to elaborate on their experience of being asked to consent after the fact and how this process occurred. Analysis: Data gathering and analysis will be undertaken simultaneously. The investigators will collaborate in developing the coding scheme, and data will be coded using NVivo. Emerging themes will be identified. Ethics and dissemination This research represents a rare opportunity to interview parents/guardians of critically ill children enrolled into a resuscitation trial without their knowledge or prior consent

  13. Exploring the experiences of substitute decision-makers with an exception to consent in a paediatric resuscitation randomised controlled trial: study protocol for a qualitative research study.

    Science.gov (United States)

    Parker, Melissa J; de Laat, Sonya; Schwartz, Lisa

    2016-09-13

    Prospective informed consent is required for most research involving human participants; however, this is impracticable under some circumstances. The Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS) outlines the requirements for research involving human participants in Canada. The need for an exception to consent (deferred consent) is recognised and endorsed in the TCPS for research in individual medical emergencies; however, little is known about substitute decision-maker (SDM) experiences. A paediatric resuscitation trial (SQUEEZE) (NCT01973907) using an exception to consent process began enrolling at McMaster Children's Hospital in January 2014. This qualitative research study aims to generate new knowledge on SDM experiences with the exception to consent process as implemented in a randomised controlled trial. The SDMs of children enrolled into the SQUEEZE pilot trial will be the sampling frame from which ethics study participants will be derived. Qualitative research study involving individual interviews and grounded theory methodology. SDMs for children enrolled into the SQUEEZE pilot trial. Up to 25 SDMs. Qualitative methodology: SDMs will be invited to participate in the qualitative ethics study. Interviews with consenting SDMs will be conducted in person or by telephone, taped and professionally transcribed. Participants will be encouraged to elaborate on their experience of being asked to consent after the fact and how this process occurred. Data gathering and analysis will be undertaken simultaneously. The investigators will collaborate in developing the coding scheme, and data will be coded using NVivo. Emerging themes will be identified. This research represents a rare opportunity to interview parents/guardians of critically ill children enrolled into a resuscitation trial without their knowledge or prior consent. Findings will inform implementation of the exception to consent process in the planned definitive SQUEEZE

  14. ENVIRONMENTAL TECHNOLOGY PROTOCOL VERIFICATION REPORT, EMISSIONS OF VOCS AND ALDEHYDES FROM COMMERCIAL FURNITURE (WITH APPENDICES)

    Science.gov (United States)

    As part of a U.S. Environmental Protection Agency Environmental Technology Verification program, the Research Triangle Institute (RTI) developed a test protocol for measuring volatile organic compounds and aldehydes in a large chamber. RTI convened stakeholders for the commercial...

  15. Zika Phase I Clinical Trial Material—From Research to Release in 90 Days | Poster

    Science.gov (United States)

    Over the past 12 months, we’ve grown accustomed to seeing Zika in the news. The virus has been linked to thousands of cases of microcephaly in Brazilian babies. Numerous countries, including the United States, have reported Zika-related deaths. And there is no vaccine available at this time. In the face of what has become a global health crisis, the Vaccine Research Center

  16. Note Taking on Trial: A Legal Application of Note-Taking Research

    Science.gov (United States)

    Kiewra, Kenneth A.

    2016-01-01

    This article is about note taking, but it is not an exhaustive review of note-taking literature. Instead, it portrays the application of note-taking research to an unusual and important area of practice--the law. I was hired to serve as an expert witness on note taking in a legal case that hinged, in part, on the completeness and accuracy of…

  17. Integration of Translational Research in the European Organization for Research and Treatment of Cancer Research (EORTC) Clinical Trial Cooperative Group Mechanisms.

    NARCIS (Netherlands)

    F. Lehmann (Frederick); D. Lacombe (Denis); A.M.M. Eggermont (Alexander)

    2003-01-01

    textabstractThe landscape for cancer research is profoundly different today from that only one decade ago. Basic science is moving rapidly and biotechnological revolutions in molecular targeting and immunology have completely modified the opportunities and concepts for cancer

  18. Design information verification

    International Nuclear Information System (INIS)

    Johnson, Shirley

    2001-01-01

    The paper provides the bases to complete a Design Information Questionnaire (DIQ) for a research reactor. The IAEA requirements for provision of design information for nuclear facility is described. The role of the provided information for the development of the safeguards approach and for planning of the IAEA's general inspection program for a specific facility is emphasized. Content and preparation of the IAEA DIQ by the State is presented

  19. A research-based strategy for managing housing adaptations: study protocol for a quasi-experimental trial.

    Science.gov (United States)

    Ekstam, Lisa; Carlsson, Gunilla; Chiatti, Carlos; Nilsson, Maria H; Malmgren Fänge, Agneta

    2014-11-29

    The primary aim of this paper is to describe the design of a project evaluating the effects of using a research-based strategy for managing housing adaptations (HAs). The evaluation targets clients' perspectives in terms of activity, participation, usability, fear of falling, fall incidence, use of mobility devices, and health-related quality of life, and determines the societal effects of HAs in terms of costs. Additional aims of the project are to explore and describe this strategy in relation to experiences and expectations (a) among clients and cohabitants and (b) occupational therapists in ordinary practice. This study is a quasi-experimental trial applying a multiphase design, combining quantitative and qualitative data. At the experimental sites, the occupational therapists (OTs) apply the intervention, i.e. a standardized research-based strategy for HA case management. At the control site, the occupational therapists are following their regular routine in relation to HA. Three municipalities in south Sweden will be included based on their population, their geographical dispersion, and their similar organizational structures for HA administration. Identical data on outcomes is being collected at all the sites at the same four time points: before the HA and then 3, 6, and 12 months after the HA. The data-collection methods are semi-structured qualitative interviews, observations, clinical assessments, and certificates related to each client's HA. The intervention in this study has been developed and tested through many years of research and in collaboration with practitioners. This process includes methodological development and testing research aimed at identifying the most important outcomes and research targeting current HA case-management procedures in Swedish municipalities. When the study is completed, the results will be used for further optimization of the practice strategy for HA, in close collaboration with the data-collecting OTs. No: NCT01960582.

  20. Self-verification and contextualized self-views.

    Science.gov (United States)

    Chen, Serena; English, Tammy; Peng, Kaiping

    2006-07-01

    Whereas most self-verification research has focused on people's desire to verify their global self-conceptions, the present studies examined self-verification with regard to contextualized selfviews-views of the self in particular situations and relationships. It was hypothesized that individuals whose core self-conceptions include contextualized self-views should seek to verify these self-views. In Study 1, the more individuals defined the self in dialectical terms, the more their judgments were biased in favor of verifying over nonverifying feedback about a negative, situation-specific self-view. In Study 2, consistent with research on gender differences in the importance of relationships to the self-concept, women but not men showed a similar bias toward feedback about a negative, relationship-specific self-view, a pattern not seen for global self-views. Together, the results support the notion that self-verification occurs for core self-conceptions, whatever form(s) they may take. Individual differences in self-verification and the nature of selfhood and authenticity are discussed.

  1. Methodology and Toolset for Model Verification, Hardware/Software co-simulation, Performance Optimisation and Customisable Source-code generation

    DEFF Research Database (Denmark)

    Berger, Michael Stübert; Soler, José; Yu, Hao

    2013-01-01

    The MODUS project aims to provide a pragmatic and viable solution that will allow SMEs to substantially improve their positioning in the embedded-systems development market. The MODUS tool will provide a model verification and Hardware/Software co-simulation tool (TRIAL) and a performance...... optimisation and customisable source-code generation tool (TUNE). The concept is depicted in automated modelling and optimisation of embedded-systems development. The tool will enable model verification by guiding the selection of existing open-source model verification engines, based on the automated analysis...

  2. Land surface Verification Toolkit (LVT)

    Science.gov (United States)

    Kumar, Sujay V.

    2017-01-01

    LVT is a framework developed to provide an automated, consolidated environment for systematic land surface model evaluation Includes support for a range of in-situ, remote-sensing and other model and reanalysis products. Supports the analysis of outputs from various LIS subsystems, including LIS-DA, LIS-OPT, LIS-UE. Note: The Land Information System Verification Toolkit (LVT) is a NASA software tool designed to enable the evaluation, analysis and comparison of outputs generated by the Land Information System (LIS). The LVT software is released under the terms and conditions of the NASA Open Source Agreement (NOSA) Version 1.1 or later. Land Information System Verification Toolkit (LVT) NOSA.

  3. Ontology Matching with Semantic Verification.

    Science.gov (United States)

    Jean-Mary, Yves R; Shironoshita, E Patrick; Kabuka, Mansur R

    2009-09-01

    ASMOV (Automated Semantic Matching of Ontologies with Verification) is a novel algorithm that uses lexical and structural characteristics of two ontologies to iteratively calculate a similarity measure between them, derives an alignment, and then verifies it to ensure that it does not contain semantic inconsistencies. In this paper, we describe the ASMOV algorithm, and then present experimental results that measure its accuracy using the OAEI 2008 tests, and that evaluate its use with two different thesauri: WordNet, and the Unified Medical Language System (UMLS). These results show the increased accuracy obtained by combining lexical, structural and extensional matchers with semantic verification, and demonstrate the advantage of using a domain-specific thesaurus for the alignment of specialized ontologies.

  4. TEST/QA PLAN FOR THE VERIFICATION TESTING OF ALTERNATIVES OR REFORMULATED LIQUID FUELS, FUEL ADDITIVES, FUEL EMULSONS, AND LUBRICANTS FOR HIGHWAY AND NONROAD USE HEAVY DUTY DIESEL ENGINES AND LIGHT DUTY GASOLINE ENGINES AND VEHICLES

    Science.gov (United States)

    The U.S. Environmental Protection Agency established the Environmental Technology Verification Program to accelerate the development and commercialization of improved environmental technology through third party verification and reporting of product performance. Research Triangl...

  5. A Correctness Verification Technique for Commercial FPGA Synthesis Tools

    International Nuclear Information System (INIS)

    Kim, Eui Sub; Yoo, Jun Beom; Choi, Jong Gyun; Kim, Jang Yeol; Lee, Jang Soo

    2014-01-01

    uses the 'Actel Libero IDE' (internally, 'Synopsys Synplify Pro') to synthesize Net list from the Verilog program, and also uses the 'EDIFtoBLIF-MV' to translate Net list into BLIF-MV. The VIS verification system is then used to prove the behavioral equivalence. This paper is organized as follows: Section 2 provides background information. Section 3 explains the developed tool, which translates EDIF to BLIF-MV. A case study with Verilog examples of a Korean nuclear power plant is presented in Section 4 and Section 5 concludes the paper and provides remarks on future research extension. This paper proposes a formal verification technique which can contribute to the correctness demonstration of commercial FPGA synthesis processes and tools in part. It formally checks the behavioral equivalence between Verilog and subsequently synthesized Net list with the VIS verification system. If the formal verification succeeds, then we can assure that the synthesis process from Verilog into Net list worked correctly at least for the Verilog program. In order to support the formal verification, we developed the mechanical translator 'EDIFtoBLIF-MV,' which translate EDIF into BLIF-MV, while preserving their behavior equivalence. The translation from EDIF into BLIF-MV consists of three steps Parsing, Pro-processing and Translation. We performed the case study with Verilog programs designed for a digital I and C system in Korea

  6. A Correctness Verification Technique for Commercial FPGA Synthesis Tools

    Energy Technology Data Exchange (ETDEWEB)

    Kim, Eui Sub; Yoo, Jun Beom [Konkuk University, Seoul (Korea, Republic of); Choi, Jong Gyun; Kim, Jang Yeol; Lee, Jang Soo [Korea Atomic Energy Research Institute, Daejeon (Korea, Republic of)

    2014-10-15

    uses the 'Actel Libero IDE' (internally, 'Synopsys Synplify Pro') to synthesize Net list from the Verilog program, and also uses the 'EDIFtoBLIF-MV' to translate Net list into BLIF-MV. The VIS verification system is then used to prove the behavioral equivalence. This paper is organized as follows: Section 2 provides background information. Section 3 explains the developed tool, which translates EDIF to BLIF-MV. A case study with Verilog examples of a Korean nuclear power plant is presented in Section 4 and Section 5 concludes the paper and provides remarks on future research extension. This paper proposes a formal verification technique which can contribute to the correctness demonstration of commercial FPGA synthesis processes and tools in part. It formally checks the behavioral equivalence between Verilog and subsequently synthesized Net list with the VIS verification system. If the formal verification succeeds, then we can assure that the synthesis process from Verilog into Net list worked correctly at least for the Verilog program. In order to support the formal verification, we developed the mechanical translator 'EDIFtoBLIF-MV,' which translate EDIF into BLIF-MV, while preserving their behavior equivalence. The translation from EDIF into BLIF-MV consists of three steps Parsing, Pro-processing and Translation. We performed the case study with Verilog programs designed for a digital I and C system in Korea.

  7. Experimental verification of internal dosimetry calculations. Annual progress report

    International Nuclear Information System (INIS)

    1980-05-01

    During the past year a dosimetry research program has been established in the School of Nuclear Engineering at the Georgia Institute of Technology. The major objective of this program has been to provide research results upon which a useful internal dosimetry system could be based. The important application of this dosimetry system will be the experimental verification of internal dosimetry calculations such as those published by the MIRD Committee

  8. Nuclear Data Verification and Standardization

    Energy Technology Data Exchange (ETDEWEB)

    Karam, Lisa R.; Arif, Muhammad; Thompson, Alan K.

    2011-10-01

    The objective of this interagency program is to provide accurate neutron interaction verification and standardization data for the U.S. Department of Energy Division of Nuclear Physics programs which include astrophysics, radioactive beam studies, and heavy-ion reactions. The measurements made in this program are also useful to other programs that indirectly use the unique properties of the neutron for diagnostic and analytical purposes. These include homeland security, personnel health and safety, nuclear waste disposal, treaty verification, national defense, and nuclear based energy production. The work includes the verification of reference standard cross sections and related neutron data employing the unique facilities and capabilities at NIST and other laboratories as required; leadership and participation in international intercomparisons and collaborations; and the preservation of standard reference deposits. An essential element of the program is critical evaluation of neutron interaction data standards including international coordinations. Data testing of critical data for important applications is included. The program is jointly supported by the Department of Energy and the National Institute of Standards and Technology.

  9. Building a recruitment database for asthma trials: a conceptual framework for the creation of the UK Database of Asthma Research Volunteers.

    Science.gov (United States)

    Nwaru, Bright I; Soyiri, Ireneous N; Simpson, Colin R; Griffiths, Chris; Sheikh, Aziz

    2016-05-26

    Randomised clinical trials are the 'gold standard' for evaluating the effectiveness of healthcare interventions. However, successful recruitment of participants remains a key challenge for many trialists. In this paper, we present a conceptual framework for creating a digital, population-based database for the recruitment of asthma patients into future asthma trials in the UK. Having set up the database, the goal is to then make it available to support investigators planning asthma clinical trials. The UK Database of Asthma Research Volunteers will comprise a web-based front-end that interactively allows participant registration, and a back-end that houses the database containing participants' key relevant data. The database will be hosted and maintained at a secure server at the Asthma UK Centre for Applied Research based at The University of Edinburgh. Using a range of invitation strategies, key demographic and clinical data will be collected from those pre-consenting to consider participation in clinical trials. These data will, with consent, in due course, be linkable to other healthcare, social, economic, and genetic datasets. To use the database, asthma investigators will send their eligibility criteria for participant recruitment; eligible participants will then be informed about the new trial and asked if they wish to participate. A steering committee will oversee the running of the database, including approval of usage access. Novel communication strategies will be utilised to engage participants who are recruited into the database in order to avoid attrition as a result of waiting time to participation in a suitable trial, and to minimise the risk of their being approached when already enrolled in a trial. The value of this database will be whether it proves useful and usable to researchers in facilitating recruitment into clinical trials on asthma and whether patient privacy and data security are protected in meeting this aim. Successful recruitment is

  10. Informed consent in oncology clinical trials: A Brown University Oncology Research Group prospective cross-sectional pilot study.

    Directory of Open Access Journals (Sweden)

    Andrew Schumacher

    Full Text Available Informed consent forms (ICFs for oncology clinical trials have grown increasingly longer and more complex. We evaluated objective understanding of critical components of informed consent among patients enrolling in contemporary trials of conventional or novel biologic/targeted therapies.We evaluated ICFs for cancer clinical trials for length and readability, and patients registered on those studies were asked to complete a validated 14-question survey assessing their understanding of key characteristics of the trial. Mean scores were compared in groups defined by trial and patient characteristics.Fifty patients, of whom half participated in trials of immunotherapy or biologic/targeted agents and half in trials of conventional therapy, completed the survey. On average, ICFs for industry-originated trials (N = 9 trials were significantly longer (P < .0001 and had lower Flesch ease-of-reading scores (P = .003 than investigator-initiated trials (N = 11. At least 80% of patients incorrectly responded to three key questions which addressed the experimental nature of their trial therapy, its purported efficacy and potential risks relative to alternative treatments. The mean objective understanding score was 76.9±8.8, but it was statistically significantly lower for patients who had not completed high school (P = .011. The scores did not differ significantly by type of cancer therapy (P = .12 or trial sponsor (P = .38.Many participants enrolled on cancer trials had poor understanding of essential elements of their trial. In order to ensure true informed consent, innovative approaches, such as expanded in-person counseling adapted to the patient's education level or cultural characteristics should be evaluated across socio-demographic groups.Clinicaltrials.gov NCT01772511.

  11. Motives for participating in a clinical research trial: a pilot study in Brazil

    Directory of Open Access Journals (Sweden)

    Nappo Solange A

    2013-01-01

    Full Text Available Abstract Background In the past, clinical study participants have suffered from the experiments that they were subjected to. Study