WorldWideScience

Sample records for research verification trials

  1. 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

  2. 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.

  3. Integrated testing and verification system for research flight software

    Science.gov (United States)

    Taylor, R. N.

    1979-01-01

    The MUST (Multipurpose User-oriented Software Technology) program is being developed to cut the cost of producing research flight software through a system of software support tools. An integrated verification and testing capability was designed as part of MUST. Documentation, verification and test options are provided with special attention on real-time, multiprocessing issues. The needs of the entire software production cycle were considered, with effective management and reduced lifecycle costs as foremost goals.

  4. 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.

  5. 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.

  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. Plan for a laser weapon verification research program

    Energy Technology Data Exchange (ETDEWEB)

    Karr, T.J.

    1990-03-01

    Currently there is great interest in the question of how, or even whether, a treaty limiting the development and deployment of laser weapons could be verified. The concept of cooperative laser weapon verification is that each party would place monitoring stations near the other party's declared or suspect laser weapon facilities. The monitoring stations would measure the primary laser observables'' such as power or energy, either directly or by collecting laser radiation scattered from the air or the target, and would verify that the laser is operated within treaty limits. This concept is modeled along the lines of the seismic network recently activated in the USSR as a joint project of the United States Geologic Survey and the Soviet Academy of Sciences. The seismic data, gathered cooperatively, can be used by each party as it wishes, including to support verification of future nuclear test ban treaties. For laser weapon verification the monitoring stations are envisioned as ground-based, and would verify treaty limitations on ground-based laser anti-satellite (ASAT) weapons and on the ground-based development of other laser weapons. They would also contribute to verification of limitations on air-, sea- and space-based laser weapons, and the technology developed for cooperative verification could also be used in national technical means of verification. 2 figs., 4 tabs.

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

    International Nuclear Information System (INIS)

    Sasajima, Fumio; Ichimura, Shigeju; Ohtomo, Akitoshi; Takayanagi, Masaji

    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 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 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)

  10. 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

  11. Reducing software security risk through an integrated approach research initiative model based verification of the Secure Socket Layer (SSL) Protocol

    Science.gov (United States)

    Powell, John D.

    2003-01-01

    This document discusses the verification of the Secure Socket Layer (SSL) communication protocol as a demonstration of the Model Based Verification (MBV) portion of the verification instrument set being developed under the Reducing Software Security Risk (RSSR) Trough an Integrated Approach research initiative. Code Q of the National Aeronautics and Space Administration (NASA) funds this project. The NASA Goddard Independent Verification and Validation (IV&V) facility manages this research program at the NASA agency level and the Assurance Technology Program Office (ATPO) manages the research locally at the Jet Propulsion Laboratory (California institute of Technology) where the research is being carried out.

  12. 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

  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. 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.

  15. 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

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

    African Journals Online (AJOL)

    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 ...

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

    International Nuclear Information System (INIS)

    Poston, J.W.

    1983-04-01

    This research has been directed toward the development of experimental techniques for the evaluation of internal-dosimetry calculations. There have been three major objectives. The first was the development and refinement of dosimetric techniques necessary to obtain absorbed doses averaged over the entire volume of particular organs. Other major objectives have included the utilization of these dosimetry systems to measure absorbed doses in anthropomorphic phantoms, and the comparison of these experimental results to absorbed dose estimates obtained from Monte Carlo computer calculations. At the present time, only limited data are available for direct comparison. However, more data should be available soon and comparisons will be made before the end of the present contract period. This proposal outlines the current status of our research toward that end. In addition, it is proposed that this contract be renewed to continue investigations into other aspects of dosimetry, for example, dosimetry for the survivors of the bombings of Hiroshima and Nagasaki

  18. Integrated testing and verification system for research flight software design document

    Science.gov (United States)

    Taylor, R. N.; Merilatt, R. L.; Osterweil, L. J.

    1979-01-01

    The NASA Langley Research Center is developing the MUST (Multipurpose User-oriented Software Technology) program to cut the cost of producing research flight software through a system of software support tools. The HAL/S language is the primary subject of the design. Boeing Computer Services Company (BCS) has designed an integrated verification and testing capability as part of MUST. Documentation, verification and test options are provided with special attention on real time, multiprocessing issues. The needs of the entire software production cycle have been considered, with effective management and reduced lifecycle costs as foremost goals. Capabilities have been included in the design for static detection of data flow anomalies involving communicating concurrent processes. Some types of ill formed process synchronization and deadlock also are detected statically.

  19. 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)

  20. 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, ...

  1. 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.

  2. 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.

  3. 78 FR 33132 - Quality Verification for Plate-Type Uranium-Aluminum Fuel Elements for Use in Research and Test...

    Science.gov (United States)

    2013-06-03

    ... Fuel Elements for Use in Research and Test Reactors AGENCY: Nuclear Regulatory Commission. ACTION... Regulatory Guide (RG) 2.3, ``Quality Verification for Plate-Type Uranium-Aluminum Fuel Elements for Use in... assurance program for verifying the quality of plate-type uranium-aluminum fuel elements used in research...

  4. Trials, tribulations, and triumphs of insider researchers

    Science.gov (United States)

    McBride, S.; Tilley, E. N.; Becker, J.; Orchiston, C.; Johnston, D. M.

    2016-12-01

    Is there merit in "insider" research? An insider researcher, in the social science context, is someone who conducts their research and provides their observations and perspectives on a project, sector or disaster setting which they are intimately familiar with. One strength of insider research is the unique insights and awareness that are gained as a consequence of the experience of working within the research setting. This could also be considered the most significant criticism of insider research, one that is fraught with bias and subjectivity. So, given their potential biases, can an insider develop worthwhile research? The trials and tribulations of an insider are many. Given the insider position, traditional observer empirical research is not ideal, so this research necessitates exploring different research theoretical perspectives, including the use of critical theory and constructivism. Constructivism-based research permits the researcher to use their unique perspectives and knowledge to `construct' knowledge through their research. However, using constructivist theoretical perspectives and methods may be a complex and challenging endeavor for those better acquainted with empirical methods. Further, ethical restrictions can create further complexities to insider research. Compounding the complexities of methodologies and theoretical perspective, an insiders' perspective can be difficult to manage, given their embedded viewpoint, and may include professional and emotional risks for the researcher. Given its many challenges, insider research is not a frequent pathway of academic examination, particularly in emergency management and natural hazards research. Triumphs of insider research endeavors become clear once ways to address methodological and ethical issues are resolved. I will explore these solutions in my presentation. Further, insider researchers laid the foundation for the contemporary emergency management discipline but this research has been largely

  5. 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.

  6. 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

  7. EXAMINING THE ROLE AND RESEARCH CHALLENGES OF SOCIAL MEDIA AS A TOOL FOR NONPROLIFERATION AND ARMS CONTROL TREATY VERIFICATION

    Energy Technology Data Exchange (ETDEWEB)

    Henry, Michael J.; Cramer, Nicholas O.; Benz, Jacob M.; Gastelum, Zoe N.; Kreyling, Sean J.; West, Curtis L.

    2014-05-13

    Traditional arms control treaty verification activities typically involve a combination of technical measurements via physical and chemical sensors, state declarations, political agreements, and on-site inspections involving international subject matter experts. However, the ubiquity of the internet, and the electronic sharing of data that it enables, has made available a wealth of open source information with the potential to benefit verification efforts. Open source information is already being used by organizations such as the International Atomic Energy Agency to support the verification of state-declared information, prepare inspectors for in-field activities, and to maintain situational awareness . The recent explosion in social media use has opened new doors to exploring the attitudes, moods, and activities around a given topic. Social media platforms, such as Twitter, Facebook, and YouTube, offer an opportunity for individuals, as well as institutions, to participate in a global conversation at minimal cost. Social media data can also provide a more data-rich environment, with text data being augmented with images, videos, and location data. The research described in this paper investigates the utility of applying social media signatures as potential arms control and nonproliferation treaty verification tools and technologies, as determined through a series of case studies. The treaty relevant events that these case studies touch upon include detection of undeclared facilities or activities, determination of unknown events recorded by the International Monitoring System (IMS), and the global media response to the occurrence of an Indian missile launch. The case studies examine how social media can be used to fill an information gap and provide additional confidence to a verification activity. The case studies represent, either directly or through a proxy, instances where social media information may be available that could potentially augment the evaluation

  8. 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

  9. 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)

  10. Moving from Efficacy to Effectiveness Trials in Prevention Research

    OpenAIRE

    Marchand, Erica; Stice, Eric; Rohde, Paul; Becker, Carolyn Black

    2010-01-01

    Efficacy trials test whether interventions work under optimal, highly controlled conditions whereas effectiveness trials test whether interventions work with typical clients and providers in real-world settings. Researchers, providers, and funding bodies have called for more effectiveness trials to understand whether interventions produce effects under ecologically valid conditions, which factors predict program effectiveness, and what strategies are needed to successfully implement programs ...

  11. 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.

  12. Managing the Verification Trajectory

    NARCIS (Netherlands)

    Ruys, T.C.; Brinksma, Hendrik

    In this paper we take a closer look at the automated analysis of designs, in particular of verification by model checking. Model checking tools are increasingly being used for the verification of real-life systems in an industrial context. In addition to ongoing research aimed at curbing the

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

    Science.gov (United States)

    Skip Navigation Bar Home Current Issue Past Issues Clinical Trials: A Crucial Key to Human Health Research Past ... the forefront of human health research today are clinical trials—studies that use human volunteers to help medical ...

  14. Verification Survey of Rooms 113, 114, and 208 of the Inhalation Toxicology Laboratory, Lovelace Respiratory Research Institute, Albuquerque, NM

    International Nuclear Information System (INIS)

    Vitkus, T.J.

    2008-01-01

    DOE-funded research with the DOE's authorized release limits. Contamination identified may be remediated or documented and left in place for incorporation into the NRC license. DOE is responsible for oversight of survey and/or remedial actions that are conducted as a result of DOE-funded missions. It is the policy of DOE to perform independent (third party) verification of the final radiological status of DOE-impacted facilities. The purpose of these independent verification activities is to confirm that remedial actions have been effective in eliminating residual contamination to levels less than the established guidelines or otherwise satisfy the intended property end use for those cases where the property will not be released for unrestricted use. Per the transition plan, the ITL is not intended to be released without radiological restriction. Instead the facility will continue research involving radioactive materials and as such will operate under an NRC license that is to include residual contamination remaining in inaccessible areas, ducts, and drains. The Independent Environmental Assessment and Verification Program (IEAV) of the Oak Ridge Institute for Science and Education (ORISE) was designated as the organization responsible for verifying the radiological status of three ITL laboratories. The laboratories are designated Rooms 113, 114, and 208. The ORISE project statement of work did not include a task for the evaluation of LRRI's survey procedures and plans (Type A verification review). Therefore, this report does not include an independent evaluation of the adequacy of the site's documentation as to the facility's radiological status. The objectives of the verification survey were to confirm that accessible surfaces of the three laboratories meet the DOE's established criteria for residual contamination. Drain pipes and ductwork were not included within the survey scope

  15. 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

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

    Science.gov (United States)

    Rapport, Frances; Storey, Mel; Porter, Alison; Snooks, Helen; Jones, Kerina; Peconi, Julie; Sánchez, Antonio; Siebert, Stefan; Thorne, Kym; Clement, Clare; Russell, Ian

    2013-02-21

    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. 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). 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. 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.

  17. 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.

  18. 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.)

  19. 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.

  20. 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.

  1. 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.

  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. 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...

  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. 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

  6. Ethical issues posed by cluster randomized trials in health research

    Directory of Open Access Journals (Sweden)

    Donner Allan

    2011-04-01

    Full Text Available Abstract The cluster randomized trial (CRT is used increasingly in knowledge translation research, quality improvement research, community based intervention studies, public health research, and research in developing countries. However, cluster trials raise difficult ethical issues that challenge researchers, research ethics committees, regulators, and sponsors as they seek to fulfill responsibly their respective roles. Our project will provide a systematic analysis of the ethics of cluster trials. Here we have outlined a series of six areas of inquiry that must be addressed if the cluster trial is to be set on a firm ethical foundation: 1. Who is a research subject? 2. From whom, how, and when must informed consent be obtained? 3. Does clinical equipoise apply to CRTs? 4. How do we determine if the benefits outweigh the risks of CRTs? 5. How ought vulnerable groups be protected in CRTs? 6. Who are gatekeepers and what are their responsibilities? Subsequent papers in this series will address each of these areas, clarifying the ethical issues at stake and, where possible, arguing for a preferred solution. Our hope is that these papers will serve as the basis for the creation of international ethical guidelines for the design and conduct of cluster randomized trials.

  7. 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)

  8. 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.)

  9. Verification and validation of neural networks: a sampling of research in progress

    Science.gov (United States)

    Taylor, Brian J.; Darrah, Marjorie A.; Moats, Christina D.

    2003-08-01

    Neural networks (NNs) represent a class of systems that do not fit into the current paradigms of software development and certification. Instead of being programmed, a learning algorithm "teaches" a NN using a set of data. Often, because of the non-deterministic result of the adaptation, the NN is considered a "black box" and its response may not be predictable. Testing the NN with similar data as that used in the training set is one of the few methods used to verify that the network has adequately learned the input domain. In most instances, such traditional testing techniques prove adequate for the acceptance of a neural network system. However, in more complex, safety- and mission-critical systems, the standard NN training-testing approach is insufficient to provide a reliable method for their certification. Verifying correct operation of NNs within NASA projects, such as autonomous mission control agents and adaptive flight controllers, and within nuclear engineering applications, such as safety assessors and reactor controllers, requires as rigorous an approach as those applied to common programming techniques. This verification and validation (V&V) challenge is further compounded by adaptive neural network systems; ones that modify themselves, or "learn," during operation. These systems continue to evolve during operation, for better or for worse. Traditional software assurance methods fail to account for systems that change after deployment. Several experimental NN V&V approaches are beginning to emerge, but no single approach has established itself as a dominant technique. This paper describes several of these current trends and assesses their compatibility with traditional V&V techniques.

  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 ... New research into HIV prevention among the “choice disabled” — vulnerable groups who are less able to make the right choices to protect themselves — has led to a groundbreaking national trial for HIV prevention in Botswana. Three years of research in southern Africa revealed important pointers for ...

  11. Formative research in clinical trial development: attitudes of patients with arthritis in enhancing prevention trials

    Science.gov (United States)

    Taylor, Holly A; Sugarman, Jeremy; Pisetsky, David S; Bathon, Joan

    2007-01-01

    In preparation for randomised controlled trials (RCTs) of disease‐modifying antirheumatic drugs in patients with early inflammatory arthritis (EIA), formative research was conducted to enhance the design of such trials. The objectives of this research were to (1) determine patients' educational needs as they relate to the necessary elements of informed consent; and (2) assess patients' interest in enrolling in a hypothetical prevention trial. In‐depth interviews were conducted with nine patients. Seven patients were women and all but one white. The mean age was 48 years. During the 4‐month enrolment period, only three patients with EIA were identified; six patients with longer duration of symptoms were also interviewed. Most patients were able to express the primary aim of a hypothetical prevention trial presented. Factors cited by patients favouring enrolment were potential for direct medical benefit and knowledge that they would be withdrawn from the trial if they developed symptoms. Factors cited by patients against enrolment were the inclusion of a placebo and general uncertainty regarding treatment required by the RCT design. Pending larger‐scale empirical projects to explore patients' attitudes about prevention trials, small‐scale formative research in advance of such trials ought to be conducted. PMID:16984939

  12. Randomised controlled trials in educational research: Ontological ...

    African Journals Online (AJOL)

    However, current theories of learning suggest that knowledge is socially constructed, and that learning occurs in open systems that cannot be controlled and manipulated as would be required in a RCT. They recognise the importance and influence of context on learning, which positivist research paradigms specifically aim ...

  13. 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.

  14. 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.

  15. 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.

  16. Consolidated Standards of Reporting Trials (CONSORT): considerations for neuropsychological research.

    Science.gov (United States)

    Miller, Justin B; Schoenberg, Mike R; Bilder, Robert M

    2014-01-01

    Evidence-based medicine (EBM) is a pillar of clinical medicine (Sackett, Rosenberg, Gray, Haynes, & Richardson, 1996 ), but only recently has this been systematically discussed within the context of clinical neuropsychology (e.g., Chelune, 2010 ). Across the medical sciences, randomized controlled trials (RCTs) are often considered the most important source of evidence for treatment efficacy. To facilitate the conduct, dissemination, and evaluation of research findings, reporting standards have been implemented, including the Consolidated Standards of Reporting Trials (CONSORT) statement. This paper considers the implications of the CONSORT statement for the reporting of clinical trials that include neuropsychological endpoints. Adopting specific guidelines for trials involving neuropsychology endpoints will ultimately serve to strengthen the empirical evidence base by increasing uniformity within the literature, decrease ambiguity in reporting, improving trial design, and fostering methodological transparency. Implementing uniform reporting standards will also facilitate meta-analytic review of evidence from published trials, benefiting researchers, clinicians, educators and practitioners, as well as journal editors, reviewers, and ultimately, health care consumers.

  17. Final Report - Independent Verification Survey Activities at the Seperations Process Research Unit Sites, Niskayuna, New York

    Energy Technology Data Exchange (ETDEWEB)

    Evan Harpenau

    2011-03-15

    The Separations Process Research Unit (SPRU) complex located on the Knolls Atomic Power Laboratory (KAPL) site in Niskayuna, New York, was constructed in the late 1940s to research the chemical separation of plutonium and uranium (Figure A-1). SPRU operated as a laboratory scale research facility between February 1950 and October 1953. The research activities ceased following the successful development of the reduction oxidation and plutonium/uranium extraction processes. The oxidation and extraction processes were subsequently developed for large scale use by the Hanford and Savannah River sites (aRc 2008a). Decommissioning of the SPRU facilities began in October 1953 and continued through the 1990s.

  18. Implementing post-trial access plans for HIV prevention research.

    Science.gov (United States)

    Paul, Amy; Merritt, Maria W; Sugarman, Jeremy

    2018-02-27

    Ethics guidance increasingly recognises that researchers and sponsors have obligations to consider provisions for post-trial access (PTA) to interventions that are found to be beneficial in research. Yet, there is little information regarding whether and how such plans can actually be implemented. Understanding practical experiences of developing and implementing these plans is critical to both optimising their implementation and informing conceptual work related to PTA. This viewpoint is informed by experiences with developing and implementing PTA plans for six large-scale multicentre HIV prevention trials supported by the HIV Prevention Trials Network. These experiences suggest that planning and implementing PTA often involve challenges of planning under uncertainty and confronting practical barriers to accessing healthcare systems. Even in relatively favourable circumstances where a tested intervention medication is approved and available in the local healthcare system, system-level barriers can threaten the viability of PTA plans. The aggregate experience across these HIV prevention trials suggests that simply referring participants to local healthcare systems for PTA will not necessarily result in continued access to beneficial interventions for trial participants. Serious commitments to PTA will require additional efforts to learn from future approaches, measuring the success of PTA plans with dedicated follow-up and further developing normative guidance to help research stakeholders navigate the complex practical challenges of realising PTA. © 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.

  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. 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

  1. 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.

  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. 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.)

  4. Intensive care unit research ethics and trials on unconscious patients.

    Science.gov (United States)

    Gillett, G R

    2015-05-01

    There are widely acknowledged ethical issues in enrolling unconscious patients in research trials, particularly in intensive care unit (ICU) settings. An analysis of those issues shows that, by and large, patients are better served in units where research is actively taking place for several reasons: i) they do not fall prey to therapeutic prejudices without clear evidential support, ii) they get a chance of accessing new and potentially beneficial treatments, iii) a climate of careful monitoring of patients and their clinical progress is necessary for good clinical research and affects the care of all patients and iv) even those not in the treatment arm of a trial of a new intervention must receive best current standard care (according to international evidence-based treatment guidelines). Given that we have discovered a number of 'best practice' regimens of care that do not optimise outcomes in ICU settings, it is of great benefit to all patients (including those participating in research) that we are constantly updating and evaluating what we do. Therefore, the practice of ICU-based clinical research on patients, many of whom cannot give prospective informed consent, ticks all the ethical boxes and ought to be encouraged in our health system. It is very important that the evaluation of protocols for ICU research should not overlook obvious (albeit probabilistic) benefits to patients and the acceptability of responsible clinicians entering patients into well-designed trials, even though the ICU setting does not and cannot conform to typical informed consent procedures and requirements.

  5. 76 FR 81991 - National Spectrum Sharing Research Experimentation, Validation, Verification, Demonstration and...

    Science.gov (United States)

    2011-12-29

    ... From the Federal Register Online via the Government Publishing Office NATIONAL SCIENCE FOUNDATION... academia will collaboratively define the concept and requirements of national level spectrum research... being the second, to bring together experts from private industry and academia to help create and...

  6. 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.

  7. 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.

  8. 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

  9. 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...... 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...... 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...

  10. 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.

  11. 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

  12. 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

  13. 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.

  14. 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.

  15. Responsible Translation of Stem Cell Research: An Assessment of Clinical Trial Registration and Publications

    OpenAIRE

    Fung, Moses; Yuan, Yan; Atkins, Harold; Shi, Qian; Bubela, Tania

    2017-01-01

    Summary We assessed the extent to which the publication of clinical trial results of innovative cell-based interventions reflects International Society for Stem Cell Research best practice guidelines. We assessed: (1) characteristics and time to publication of completed trials; (2) quality of reported trials; and (3) results of published trials. We identified and analyzed publications from 1,052 novel stem cell clinical trials: 179 (45.4%) of 393 completed trials had published results; 48 tri...

  16. 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

  17. 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

  18. Research results on DH-no.13 of trial drilling excavation and its survey research. A rapid report. Research report

    International Nuclear Information System (INIS)

    2001-08-01

    In the Tono Geoscience Center, as a part of the stratum science research, study on wide area groundwater flow was carried out since 1992 fiscal year. This study aims at development on survey and analytical technology required for elucidation of groundwater flow till underground depth and water quality and development on technique to evaluate validity on its survey and analytical results, for objective of an area with 10 km x 10 km containing the Tono mine. This report is a summary on outline of results on trial drilling excavation and various survey researches carried out at DH-no.13 hole excavated on the 13th trial drilling for the study. This hole is excavated at Hiyoshi-cho in Mizunami-city, Gifu prefecture, and has 1015.05 m in depth of its excavation. Here were reported on geological outlines, and results on trial drilling excavation and its survey research. (G.K.)

  19. 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.

  20. 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. ...

  1. 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

  2. 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

  3. Quality of reporting randomized controlled trials in cancer nursing research.

    Science.gov (United States)

    Guo, Jia-Wen; Sward, Katherine A; Beck, Susan L; Staggers, Nancy

    2014-01-01

    Results of randomized controlled trials (RCTs) provide high-level evidence for evidence-based practice (EBP). The quality of RCTs has a substantial influence on providing reliable knowledge for EBP. Little is known about the quality of RCT reporting in cancer nursing. The aim of this study was to assess the quality of reporting in published cancer nursing RCTs from 1984 to 2010. A total of 227 RCTs in cancer nursing published in English-language journals and indexed in PubMed or Cumulative Index to Nursing and Allied Health Literature were reviewed using the Jadad scale, key methodologic index (KMI), and the Consolidated Standards of Reporting Trials (CONSORT) checklist to assess the quality of reporting methodological aspects of research and the overall quality of reporting RCTs. Adherence to reporting metrics was relatively low, based on the Jadad score (M = 1.94 out of 5, SD = 1.01), KMI scores (M = 0.84 out of 3, SD = .87), and adherence to CONSORT checklist items (M =16.92 out of 37, SD = 4.03). Only 11 of 37 items in the CONSORT checklist were reported in 80% or more of the studies reviewed. The quality of reporting showed some improvement over time. Adherence to reporting metrics for cancer nursing RCTs was suboptimal, and further efforts are needed to improve both methodology reporting and overall reporting. Journals are encouraged to adopt the CONSORT checklist to influence the quality of RCT reports.

  4. Engaging adolescents in tuberculosis and clinical trial research through drama.

    Science.gov (United States)

    Schmidt, Bey-Marrié; Abrams, Amber; Tameris, Michele

    2016-04-06

    The South African Tuberculosis Vaccine Initiative is based in Worcester where tuberculosis (TB) is endemic, and incidence rates are amongst the highest nationally. In high TB burden settings after an early childhood peak, incidence rates start to rise again in adolescents, therefore they are an important target group for tuberculosis vaccine research. In 2012, learners from a local school developed a one-off theatrical production out of an educational comic book Carina's Choice, developed by the South African Tuberculosis Vaccine Initiative in 2010. A Wellcome Trust International Engagement grant allowed for this one-off production to be further developed, with input from university students and staff, and rolled out to schools in the Worcester area as an engagement and education intervention. Focus group feedback was used to identify key messages and to develop the play's script. Qualitative methods were used to collect and analyse relevant data. Interviews were conducted with learner-actors, pre- and post-focus group feedback was obtained from a sample of school-going adolescents, and pre- and post-questionnaires were administered to adolescent audience members. From the pre-drama focus group discussions, topics such as TB symptoms, stigma and transmission were identified as areas that needed attention. After the performances, adolescents showed improved knowledge on the identified topics and they discussed TB prevention measures. They highlighted transmission of TB during pregnancy as a further topic to be addressed in future iterations of the drama. Although stigma is a difficult phenomenon to interpret, post-drama participants understood that TB transmission could occur in all individuals. Learner-actors agreed with focus group participants that the play could impact the wider community if it were rolled out. Feedback from the South African Tuberculosis Vaccine Initiative staff verified that recruitment for an upcoming trial was facilitated by the preparedness

  5. Qualitative analysis of clinical research coordinators' role in phase I cancer clinical trials

    OpenAIRE

    Noriko Fujiwara; Ryota Ochiai; Yuki Shirai; Yuko Saito; Fumitaka Nagamura; Satoru Iwase; Keiko Kazuma

    2017-01-01

    Background: Clinical research coordinators play a pivotal role in phase I cancer clinical trials. Purpose: We clarified the care coordination and practice for patients provided by clinical research coordinators in phase I cancer clinical trials in Japan and elucidated clinical research coordinators' perspective on patients' expectations and understanding of these trials. Method: Fifteen clinical research coordinators participated in semi-structured interviews regarding clinical practice...

  6. 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)

  7. Dosimetric verification of IMRT treatment plans at the German Cancer Research Center (DKFZ); Dosimetrische Verifikation von IMRT-Gesamtplaenen am Deutschen Krebsforschungszentrum Heidelberg

    Energy Technology Data Exchange (ETDEWEB)

    Rhein, B.; Haering, P.; Debus, J.; Schlegel, W. [Deutsches Krebsforschungszentrum, Heidelberg (Germany)

    2002-07-01

    The present paper describes a method for the individual dosimetric verification of IMRT treatment plans. The German Cancer Research Center (Deutsches Krebsforschungszentrum; DKFZ) has implemented the intensity modulated radiotherapy (IMRT) since 1997. So far, 246 patients with head and neck cancer, cancer of the prostate, breast, and vertebral column, as well as mesothelioma of the pleura have been treated. Every IMRT plan is transferred into a special IMRT verification phantom, recalculated, and dosimetrically verified. Absolute dose distributions are measured with Kodak EDR films and compared with the results of the dose calculation. After correction of the optical density in relationship to the dose, EDR films are able to measure the absolute dose with an accuracy of {+-}2% compared to an ionization chamber. A Visual C{sup ++} software tool has been developed to correlate and evaluate the film dose distributions with the corresponding slices of the 3D dose cube. Beside the overlay of absolute or relative isodoses and dose profiles, the median dose within correlated regions of interest (ROIs) is also included in the quantitative dose evaluation. The deviation between EDR film dosimetry and dose calculation is {delta}D=-0.3%{+-}2.3%. After introduction of the verification software, the total verification time (including handling, correlation, evaluation, and documentation of the data), could be reduced to less than 2 hours. (orig.) [German] In dieser Arbeit wird eine Methode zur individuellen dosimetrischen Ueberpruefung von IMRT-Bestrahlungsplaenen beschrieben. Am Deutschen Krebsforschungszentrum (DKFZ) wird die intensitaetsmodulierte Strahlentherapie (IMRT) seit 1997 durchgefuehrt. 246 Patienten mit Tumoren im Kopf-Hals Bereich, der Wirbelsaeule, der Prostata, der weiblichen Brust und Pleuramesotheliome wurden bisher bestrahlt. Jeder IMRT-Bestrahlungsplan wird in ein spezielles Verifikationsphantom uebertragen, dort neu berechnet und dosimetrisch verifiziert

  8. 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.

  9. 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.

  10. Who is the research subject in 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, 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. PMID:21791064

  11. How clinical trials really work rethinking research ethics.

    Science.gov (United States)

    DeBruin, Debra A; Liaschenko, Joan; Fisher, Anastasia

    2011-06-01

    Despite prevalent concerns about the ethical conduct of clinical trials, little is known about the day-to-day work of trials and the ethical challenges arising in them. This paper reports on a study designed to fill this gap and demonstrates a need to refine the oversight system for trials to reflect an understanding of this day-to-day work. It also illuminates ethical challenges that cannot be addressed by the oversight system and so necessitate a rethinking of the ethics of clinical trials.

  12. Recruitment of Underrepresented Minority Researchers into HIV Prevention Research: The HIV Prevention Trials Network Scholars Program

    Science.gov (United States)

    Hamilton, Erica L.; Griffith, Sam B.; Jennings, Larissa; Dyer, Typhanye V.; Mayer, Kenneth; Wheeler, Darrell

    2018-01-01

    Abstract Most U.S. investigators in the HIV Prevention Trials Network (HPTN) have been of majority race/ethnicity and sexual orientation. Research participants, in contrast, have been disproportionately from racial/ethnic minorities and men who have sex with men (MSM), reflecting the U.S. epidemic. We initiated and subsequently evaluated the HPTN Scholars Program that mentors early career investigators from underrepresented minority groups. Scholars were affiliated with the HPTN for 12–18 months, mentored by a senior researcher to analyze HPTN study data. Participation in scientific committees, trainings, protocol teams, and advisory groups was facilitated, followed by evaluative exit surveys. Twenty-six trainees have produced 17 peer-reviewed articles to date. Research topics typically explored health disparities and HIV prevention among black and Hispanic MSM and at-risk black women. Most scholars (81% in the first five cohorts) continued HIV research after program completion. Alumni reported program-related career benefits and subsequent funding successes. Their feedback also suggested that we must improve the scholars' abilities to engage new research protocols that are developed within the network. Mentored engagement can nurture the professional development of young researchers from racial/ethnic and sexual minority communities. Minority scientists can benefit from training and mentoring within research consortia, whereas the network research benefits from perspectives of underrepresented minority scientists. PMID:29145745

  13. Adaptive trial design: its growing role in clinical research and implications for pharmacists.

    Science.gov (United States)

    Cirulli, Joshua; McMillian, Wesley D; Saba, Mojdeh; Stenehjem, David

    2011-05-01

    Current trends and recent developments in use of adaptive trial design methodology for pharmaceutical research, as well as barriers to wider acceptance and implications for pharmacists, are discussed. Traditional clinical drug trials typically take many months or years to complete. In contrast, trials incorporating adaptive design elements allow researchers to make midstudy adjustments so that trial objectives are addressed more efficiently. Properly designed adaptive trials can enable researchers to conclude trials of unsuccessful treatments earlier or bring effective drugs to market sooner, improving patient safety and yielding substantial time and cost savings. Challenges and concerns with adaptive trial methodology include inadequate knowledge of adaptive design techniques among health care professionals and increased potential for bias or misinterpretation of trial results stemming from earlier access to data. Over the past decade, U.S. and European regulatory bodies have issued a number of documents to better define acceptable practices for designing, conducting, and reporting the results of adaptive trials, including updated Food and Drug Administration guidance released in 2010. Pharmacists need to stay current with developments in the field to properly assess and interpret trial results. Adaptive trial design is an emerging study methodology that allows for design modifications during a study, with the objective of implementing trial data as early as possible for the benefit of patients and the drug development process.

  14. 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.

  15. Effect of verification cores on tip capacity of drilled shafts.

    Science.gov (United States)

    2009-02-01

    This research addressed two key issues: : 1) Will verification cores holes fill during concrete backfilling? If so, what are the mechanical properties of the : filling material? In dry conditions, verification core holes always completely fill with c...

  16. Compositional Verification of Multi-Station Interlocking Systems

    DEFF Research Database (Denmark)

    Macedo, Hugo Daniel dos Santos; Fantechi, Alessandro; Haxthausen, Anne Elisabeth

    2016-01-01

    Because interlocking systems are highly safety-critical complex systems, their automated safety verification is an active research topic investigated by several groups, employing verification techniques to produce important cost and time savings in their certification. However, such systems also...

  17. The Brave New World of clinical cancer research: Adaptive biomarker-driven trials integrating clinical practice with clinical research.

    Science.gov (United States)

    Berry, Donald A

    2015-05-01

    Clinical trials are the final links in the chains of knowledge and for determining the roles of therapeutic advances. Unfortunately, in an important sense they are the weakest links. This article describes two designs that are being explored today: platform trials and basket trials. Both are attempting to merge clinical research and clinical practice. Copyright © 2015 Federation of European Biochemical Societies. Published by Elsevier B.V. All rights reserved.

  18. 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

  19. [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.

  20. 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

  1. Future directions of nuclear verification

    International Nuclear Information System (INIS)

    Blix, H.

    1997-01-01

    Future directions of nuclear verification are discussed including the following topics: verification of non-proliferation commitments; practicalities of strengthening safeguards; new tasks in nuclear verification

  2. 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.

  3. Responsible Translation of Stem Cell Research: An Assessment of Clinical Trial Registration and Publications.

    Science.gov (United States)

    Fung, Moses; Yuan, Yan; Atkins, Harold; Shi, Qian; Bubela, Tania

    2017-05-09

    We assessed the extent to which the publication of clinical trial results of innovative cell-based interventions reflects International Society for Stem Cell Research best practice guidelines. We assessed: (1) characteristics and time to publication of completed trials; (2) quality of reported trials; and (3) results of published trials. We identified and analyzed publications from 1,052 novel stem cell clinical trials: 179 (45.4%) of 393 completed trials had published results; 48 trials were registered by known stem cell tourism clinics, none of which reported results. Completed non-industry-sponsored trials initially published more rapidly, but differences with industry-sponsored trials decreased over time. Most publications reported safety, and 67.3% (mainly early-stage trials) reported positive outcomes. A higher proportion of industry trials reported positive efficacy. Heightened patient expectations for stem cell therapies give rise to ethical obligations for the transparent conduct of clinical trials. Reporting guidelines need to be developed that are specific to early-phase clinical trials. Copyright © 2017 The Author(s). Published by Elsevier Inc. All rights reserved.

  4. Evaluation of occupational health interventions using a randomized controlled trial: challenges and alternative research designs

    NARCIS (Netherlands)

    Schelvis, R.M; Oude Hengel, K.M.; Burdorf, A.; Blatter, B.M.; Strijk, J.E.; Beek, A.J. van

    2015-01-01

    Occupational health researchers regularly conduct evaluative intervention research for which a randomized controlled trial (RCT) may not be the most appropriate design (eg, effects of policy measures, organizational interventions on work schedules). This article demonstrates the appropriateness of

  5. 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.

  6. [New Royal Decree on clinical trials: main implications for emergency medicine physicians who do research].

    Science.gov (United States)

    García Arenillas, Mar; Haj-Ali Saflo, Okba; Sáenz de Tejada, Marta

    2017-06-01

    The new European Union directives affecting clinical trials of medicines introduced important changes for Spain, leading to the publication of a Royal Decree regulating the conduct of clinical trials that went into effect in January 2016. The decree sets out the principles for complying with the EU directives, regulates the work of institutional review boards (IRBs) or ethics committees that review research proposals, introduces means to facilitate clinical research, and clarifies the role of the Spanish register of clinical trials, among other topics. This paper discusses the main changes that have been introduced, especially those intended to facilitate research, such as the new concepts of low intervention trial and noncommercial clinical research. These concepts may be particularly useful for clinical trials designed by emergency medicine physicians. We also comment on changes affecting vulnerable populations and the documents that must be presented to both the researchers' IRB and the Spanish Agency for Medicines and Health Care Products.

  7. 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.

  8. SU-E-J-146: A Research of PET-CT SUV Range for the Online Dose Verification in Carbon Ion Radiation Therapy

    International Nuclear Information System (INIS)

    Sun, L; Hu, W; Moyers, M; Zhao, J; Hsi, W

    2015-01-01

    Purpose: Positron-emitting isotope distributions can be used for the image fusion of the carbon ion planning CT and online target verification PETCT, after radiation in the same decay period,the relationship between the same target volume and the SUV value of different every single fraction dose can be found,then the range of SUV for the radiation target could be decided.So this online range also can provide reference for the correlation and consistency in planning target dose verification and evaluation for the clinical trial. Methods: The Rando head phantom can be used as real body,the 10cc cube volume target contouring is done,beam ISO Center depth is 7.6cm and the 90 degree fixed carbon ion beams should be delivered in single fraction effective dose of 2.5GyE,5GyE and 8GyE.After irradiation,390 seconds later the 30 minutes PET-CT scanning is performed,parameters are set to 50Kg virtual weight,0.05mCi activity.MIM Maestro is used for the image processing and fusion,five 16mm diameter SUV spheres have been chosen in the different direction in the target.The average SUV in target for different fraction dose can be found by software. Results: For 10cc volume target,390 seconds decay period,the Single fraction effective dose equal to 2.5Gy,Ethe SUV mean value is 3.42,the relative range is 1.72 to 6.83;Equal to 5GyE,SUV mean value is 9.946,the relative range is 7.016 to 12.54;Equal or above to 8GyE,SUV mean value is 20.496,the relative range is 11.16 to 34.73. Conclusion: Making an evaluation for accuracy of the dose distribution using the SUV range which is from the planning CT with after treatment online PET-CT fusion for the normal single fraction carbon ion treatment is available.Even to the plan which single fraction dose is above 2GyE,in the condition of other parameters all the same,the SUV range is linearly dependent with single fraction dose,so this method also can be used in the hyper-fraction treatment plan

  9. 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

  10. 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

  11. 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

  12. The SeaHorn Verification Framework

    Science.gov (United States)

    Gurfinkel, Arie; Kahsai, Temesghen; Komuravelli, Anvesh; Navas, Jorge A.

    2015-01-01

    In this paper, we present SeaHorn, a software verification framework. The key distinguishing feature of SeaHorn is its modular design that separates the concerns of the syntax of the programming language, its operational semantics, and the verification semantics. SeaHorn encompasses several novelties: it (a) encodes verification conditions using an efficient yet precise inter-procedural technique, (b) provides flexibility in the verification semantics to allow different levels of precision, (c) leverages the state-of-the-art in software model checking and abstract interpretation for verification, and (d) uses Horn-clauses as an intermediate language to represent verification conditions which simplifies interfacing with multiple verification tools based on Horn-clauses. SeaHorn provides users with a powerful verification tool and researchers with an extensible and customizable framework for experimenting with new software verification techniques. The effectiveness and scalability of SeaHorn are demonstrated by an extensive experimental evaluation using benchmarks from SV-COMP 2015 and real avionics code.

  13. 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

  14. 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.

  15. 77 FR 16868 - Quality Verification for Plate-Type Uranium-Aluminum Fuel Elements for Use in Research and Test...

    Science.gov (United States)

    2012-03-22

    ... Fuel Elements for Use in Research and Test Reactors AGENCY: Nuclear Regulatory Commission. ACTION... Plate-Type Uranium-Aluminum Fuel Elements for Use in Research and Test Reactors.'' This guide describes... plate-type uranium-aluminum fuel elements used in research and test reactors (RTRs). DATES: Submit...

  16. 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.

  17. Clinical Trials

    Medline Plus

    Full Text Available ... Back To Health Topics / About Clinical Trials About Clinical Trials Clinical trials are research studies that explore whether a ... is safe and effective for humans. What Are Clinical Trials? Clinical trials are research studies that explore ...

  18. Verification of ceramic structures

    NARCIS (Netherlands)

    Behar-Lafenetre, S.; Cornillon, L.; Rancurel, M.; Graaf, D. de; Hartmann, P.; Coe, G.; Laine, B.

    2012-01-01

    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

  19. 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

  20. 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.

  1. 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 ...

  2. Comparing formal verification approaches of interlocking systems

    DEFF Research Database (Denmark)

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

    2016-01-01

    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...... 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...

  3. 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.

  4. The unseen and untold issues of clinical trials and research ethics in ...

    African Journals Online (AJOL)

    McRoy

    The unseen and untold issues of clinical trials and research ethics in Pakistan. Waheed S*, Siddiqui E. Department of Emergency ... attention, as the pharmaceutical companies has to enroll patients for their clinical trials; they visit ... collaborations and for obtaining funding. However, there are some impurities mixing in it as.

  5. 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.

  6. Research in Nursing and Nutrition: Is Randomized Clinical Trial the Actual Gold Standard?

    Science.gov (United States)

    Baldi, Ileana; Soriani, Nicola; Lorenzoni, Giulia; Azzolina, Danila; Dal Lago, Elisa; De Bardi, Sara; Verduci, Elvira; Zanotti, Renzo; Gregori, Dario

    The aim of this study was to assess the quality of reporting of nurse-driven randomized controlled trials involving a direct nutritional intervention. A bibliometric search for randomized controlled trials involving a direct nutritional intervention from 1991 to 2011 in nursing research was conducted. Both quality of the study and design aspects were evaluated. The prevalent randomized controlled trial design used is 2-arm parallel, individual, and randomized with a continuous primary endpoint. Global numbers of randomized controlled trials and the proportion of good-quality randomized controlled trials began a steady and marked rise, more than doubling, from the 1990s to about 2001 and increased slowly thereafter. Studies are overall sufficiently well designed, although there is still room for quality improvement. Additionally, implementation of new randomized controlled trial designs exists and should be advocated.

  7. SEMI-AUTOMATIC SPEAKER VERIFICATION SYSTEM

    Directory of Open Access Journals (Sweden)

    E. V. Bulgakova

    2016-03-01

    Full Text Available Subject of Research. The paper presents a semi-automatic speaker verification system based on comparing of formant values, statistics of phone lengths and melodic characteristics as well. Due to the development of speech technology, there is an increased interest now in searching for expert speaker verification systems, which have high reliability and low labour intensiveness because of the automation of data processing for the expert analysis. System Description. We present a description of a novel system analyzing similarity or distinction of speaker voices based on comparing statistics of phone lengths, formant features and melodic characteristics. The characteristic feature of the proposed system based on fusion of methods is a weak correlation between the analyzed features that leads to a decrease in the error rate of speaker recognition. The system advantage is the possibility to carry out rapid analysis of recordings since the processes of data preprocessing and making decision are automated. We describe the functioning methods as well as fusion of methods to combine their decisions. Main Results. We have tested the system on the speech database of 1190 target trials and 10450 non-target trials, including the Russian speech of the male and female speakers. The recognition accuracy of the system is 98.59% on the database containing records of the male speech, and 96.17% on the database containing records of the female speech. It was also experimentally established that the formant method is the most reliable of all used methods. Practical Significance. Experimental results have shown that proposed system is applicable for the speaker recognition task in the course of phonoscopic examination.

  8. 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

  9. 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...

  10. Procedure Verification and Validation Toolset Project

    Data.gov (United States)

    National Aeronautics and Space Administration — The proposed research is aimed at investigating a procedure verification and validation toolset, which will allow the engineers who are responsible for developing...

  11. 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.

  12. Feasibility of Reducing the Duration of Placebo-Controlled Trials in Schizophrenia Research

    Science.gov (United States)

    Hu, Qiaoyan; Davis, John M.; Carpenter, William T.

    2008-01-01

    Use of placebo-controlled trials in medical and psychiatric research has been controversial, although a consensus is emerging about conditions under which placebo-controlled trials are ethical. In schizophrenia research, the paradigm of slow onset of antipsychotic effects has led to a model in which placebo-controlled trials of 6–8 weeks duration have been used to demonstrate efficacy. Recent evidence that the largest symptom reductions are typically seen in the first weeks of treatment suggests that shorter placebo-controlled studies to demonstrate antipsychotic efficacy are possible. In a pilot study of the feasibility of shortening placebo-controlled studies, we reanalyzed data from placebo-controlled registry trials of olanzapine and risperidone and found that trials as short as 4 weeks could have similar power to longer term 6–8 week studies, given the estimated time course of treatment effects. Although fuller evaluation is required, the results suggest future antipsychotic trials could be shortened from 6–8 weeks to 3–4 weeks with a relatively low increase in sample size requirements. Shortening placebo-controlled trials would reduce patient burden and ethical objections to prolonged administration of placebo and reduce potential bias due to high dropout rates in longer clinical trials. PMID:18184634

  13. 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

  14. 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

  15. 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

  16. 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)

  17. 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

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

    African Journals Online (AJOL)

    In this article I deal with extending the ethical principles of research to include communities through the establishment of Community Advisory Boards (CABs). The aim of the project on which this article is based demonstrates the need for protecting communities that participate in research in order to stimulate ethical conduct ...

  19. Clinical Research Trials and You: Questions and Answers

    Science.gov (United States)

    ... place today were primarily a response to past research abuses. Informed Consent Informed consent is the process of learning the ... team explain the details of the study. The research team provides an informed consent document, which includes such details about the study, ...

  20. 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.

  1. 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).

  2. 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.

  3. 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.

  4. Software verification and testing

    Science.gov (United States)

    1985-01-01

    General procedures for software verification and validation are provided as a guide for managers, programmers, and analysts involved in software development. The verification and validation procedures described are based primarily on testing techniques. Testing refers to the execution of all or part of a software system for the purpose of detecting errors. Planning, execution, and analysis of tests are outlined in this document. Code reading and static analysis techniques for software verification are also described.

  5. 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)

  6. 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.)

  7. 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

  8. 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

  9. 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.

  10. 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 ...

  11. Nurse Practitioners' attitudes about cancer clinical trials and willingness to recommend research participation

    Science.gov (United States)

    Ulrich, Connie M.; Zhou, Quiping; Ratcliffe, Sarah J.; Ye, Lichuan; Grady, Christine; Watkins-Bruner, Deborah

    2016-01-01

    regarding the translatability of research to clinical practice to increase their knowledge and comfort level with discussing clinical trials. PMID:21983623

  12. 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

  13. 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.

  14. 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.

  15. Challenges in the research ethics review of cluster randomized trials: international survey of investigators.

    Science.gov (United States)

    Chaudhry, Shazia H; Brehaut, Jamie C; Grimshaw, Jeremy M; Weijer, Charles; Boruch, Robert; Donner, Allan; Eccles, Martin P; McRae, Andrew D; Saginur, Raphael; Skea, Zoë C; Zwarenstein, Merrick; Taljaard, Monica

    2013-04-01

    Cluster randomized trials (CRTs) complicate the interpretation of standard research ethics guidelines for several reasons. For one, the units of allocation, intervention, and observation often may differ within a single trial. In the absence of tailored and internationally accepted ethics guidelines for CRTs, researchers and research ethics committees have no common standard by which to judge ethically appropriate practices in CRTs. Moreover, lack of familiarity with and consideration of the unique features of the CRT design by research ethics committees may cause difficulties in the research ethics review process, and amplify problems such as variability in the requirements and decisions reached by different research ethics committees. We aimed to characterize research ethics review of CRTs, examine investigator experiences with the ethics review process, and assess the need for ethics guidelines for CRTs. An electronic search strategy implemented in MEDLINE was used to identify and randomly sample 300 CRTs published in English language journals from 2000 to 2008. A web-based survey with closed- and open-ended questions was administered to corresponding authors in a series of six contacts. The survey response rate was 64%. Among 182 of 285 eligible respondents, 91% indicated that they had sought research ethics approval for the identified CRT, although only 70% respondents reported research ethics approval in the published article. Nearly one-third (31%) indicated that they have had to meet with ethics committees to explain aspects of their trials, nearly half (46%) experienced variability in the ethics review process in multijurisdictional trials, and 38% experienced negative impacts of the ethics review process on their trials, including delays in trial initiation (28%), increased costs (10%), compromised ability to recruit participants (16%), and compromised methodological quality (9%). Most respondents (74%; 95% confidence interval (CI): 67%-80%) agreed or

  16. 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 ...

  17. Trials and tribulations of clinical research teaching and training

    Directory of Open Access Journals (Sweden)

    Ravindra B Ghooi

    2010-01-01

    Full Text Available Clinical research institutions have mushroomed in the country, though there is a generalized lack of experienced faculty. These institutes mostly confine themselves to theoretical aspects of clinical research, since there is lack of facilities for practical training. Students passing out of these institutes often find it difficult to get decent jobs and salaries at the entry level in the industry are poor. Poor placements of graduating students become major barriers for attracting quality students to the courses. This in turn affects the quality of people that the industry requires, in order to ensure a high growth rate of the industry. The industry, in addition to facing a severe crunch of high quality professionals, is also suffering from attrition that is a common feature. This attrition stems from, inter alia the industry′s demand for experienced people at the entry level. To improve overall standards of professionals entering clinical research, institutes and the industry need to get together and work in close co-operation. The industry and the institutes need to take positive steps if recent trends have to be reversed and clinical research as a whole has to move to a higher level. This article is based on the perceptions of the author, about the problems faced and offers some suggestions. Though these perceptions represent the reality, it is difficult to provide hard evidence that they do so.

  18. Avoidable waste of research related to inadequate methods in clinical trials.

    Science.gov (United States)

    Yordanov, Youri; Dechartres, Agnes; Porcher, Raphaël; Boutron, Isabelle; Altman, Douglas G; Ravaud, Philippe

    2015-03-24

    To assess the waste of research related to inadequate methods in trials included in Cochrane reviews and to examine to what extent this waste could be avoided. A secondary objective was to perform a simulation study to re-estimate this avoidable waste if all trials were adequately reported. Methodological review and simulation study. Trials included in the meta-analysis of the primary outcome of Cochrane reviews published between April 2012 and March 2013. We collected the risk of bias assessment made by the review authors for each trial. For a random sample of 200 trials with at least one domain at high risk of bias, we re-assessed risk of bias and identified all related methodological problems. For each problem, possible adjustments were proposed that were then validated by an expert panel also evaluating their feasibility (easy or not) and cost. Avoidable waste was defined as trials with at least one domain at high risk of bias for which easy adjustments with no or minor cost could change all domains to low risk. In the simulation study, after extrapolating our re-assessment of risk of bias to all trials, we considered each domain rated as unclear risk of bias as missing data and used multiple imputations to determine whether they were at high or low risk. Of 1286 trials from 205 meta-analyses, 556 (43%) had at least one domain at high risk of bias. Among the sample of 200 of these trials, 142 were confirmed as high risk; in these, we identified 25 types of methodological problem. Adjustments were possible in 136 trials (96%). Easy adjustments with no or minor cost could be applied in 71 trials (50%), resulting in 17 trials (12%) changing to low risk for all domains. So the avoidable waste represented 12% (95% CI 7% to 18%) of trials with at least one domain at high risk. After correcting for incomplete reporting, avoidable waste due to inadequate methods was estimated at 42% (95% CI 36% to 49%). An important burden of wasted research is related to inadequate

  19. Scalable hardware verification with symbolic simulation

    CERN Document Server

    Bertacco, Valeria

    2006-01-01

    An innovative presentation of the theory of disjoint support decomposition, presenting novel results and algorithms, plus original and up-to-date techniques in formal verificationProvides an overview of current verification techniques, and unveils the inner workings of symbolic simulationFocuses on new techniques that narrow the performance gap between the complexity of digital systems and the limited ability to verify themAddresses key topics in need of future research.

  20. 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.

  1. 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...... 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...... 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...

  2. 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...

  3. 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...

  4. 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.

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

    Science.gov (United States)

    2007-02-01

    YBRID M O DELS IN TEJA ................................................................................... 40 Sequential coordinator...37 APPENDIX B : HYBRID M ODELS IN TEJA ................................................................................... 39 Sequential...time or time bounded constraints. The subsystems have been implemented using a high level programming environment provided by Teja . 5 6 Verification of a

  6. 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

  7. 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.

  8. The MeTeOR trial (Meniscal Tear in Osteoarthritis Research): rationale and design features.

    Science.gov (United States)

    Katz, Jeffrey N; Chaisson, Christine E; Cole, Brian; Guermazi, Ali; Hunter, David J; Jones, Morgan; Levy, Bruce A; Mandl, Lisa A; Martin, Scott; Marx, Robert G; Safran-Norton, Clare; Roemer, Frank W; Skoniecki, Debra; Solomon, Daniel H; Spindler, Kurt P; Wright, John; Wright, Rick W; Losina, Elena

    2012-11-01

    This paper presents the rationale and design features of the MeTeOR Trial (Meniscal Tear in Osteoarthritis Research; Clinical Trials.gov NCT00597012). MeTeOR is an NIH-funded seven-center prospective randomized controlled trial (RCT) designed to establish the efficacy of arthroscopic partial meniscectomy combined with a standardized physical therapy program as compared with a standardized physical therapy program alone in patients with a symptomatic meniscal tear in the setting of mild to moderate knee osteoarthritic change (OA). The design and execution of a trial that compares surgery with a nonoperative treatment strategy presents distinctive challenges. The goal of this paper is to provide the clinical rationale for MeTeOR and to highlight salient design features, with particular attention to those that present clinical and methodologic challenges. Copyright © 2012 Elsevier Inc. All rights reserved.

  9. 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.

  10. 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.

  11. 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

  12. International clinical trials, cardiovascular disease and treatment options in the Russian Federation: research and treatment in practice.

    Science.gov (United States)

    Zvonareva, Olga; Engel, Nora; Martsevich, Sergey; de Wert, Guido; Horstman, Klasien

    2015-03-01

    The issue of balance between research and treatment in clinical trials conduct has been surrounded by controversies. Scientific characteristics of trials may compromise medical care available to participants, while conceiving research participation as having therapeutic value may foster the therapeutic misconception. However, it has also been questioned whether research can and should always be separated from medical care provision. In this paper we analyze how these concerns played out in practice settings of the three trial sites in Russia, specialized in trials in cardiovascular diseases. Using in-depth interviews with participants of phase II and III trials (n = 21) and discussions with physician-investigators (n = 7), we found that trial enrollment allowed participants to establish continuous supportive relationships with the physician-investigators. In the context of unresponsive health care, chronically ill participants received regular monitoring, treatment recommendations and help in case of problems and emergencies through such relationships. The trial designs in the three sites did not preclude the provision of individualized treatment. We suggest that debates about the research/treatment interface in trials need to become more attuned to the conditions in locations of their conduct, views and experiences of actors involved and evolving trial methodologies. Too much focus on categorical differentiation of research and treatment may obscure the fact that globalizing clinical trials proceed amidst profound health disparities, dismiss diverse concerns of people on the ground and risk attenuating responsibilities of trial organizers, sponsors and investigators towards research participants. Copyright © 2015 Elsevier Ltd. All rights reserved.

  13. 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

  14. 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.

  15. 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

  16. 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

  17. 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.

  18. 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

  19. 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

  20. 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)

  1. Predictors of missed research appointments in a randomized placebo-controlled trial

    NARCIS (Netherlands)

    Becker, Stéphanie J. E.; Guitton, Thierry G.; Ring, David

    2014-01-01

    The primary aim of this study was to determine predictors of missed research appointments in a prospective randomized placebo injection-controlled trial with evaluations 1 to 3 and 5 to 8 months after enrollment. This study represents a secondary use of data from 104 patients that were enrolled in a

  2. 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 ...

  3. 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

  4. Lesson Study to Scale up Research-Based Knowledge: A Randomized, Controlled Trial of Fractions Learning

    Science.gov (United States)

    Lewis, Catherine; Perry, Rebecca

    2017-01-01

    An understanding of fractions eludes many U.S. students, and research-based knowledge about fraction, such as the utility of linear representations, has not broadly influenced instruction. This randomized trial of lesson study supported by mathematical resources assigned 39 educator teams across the United States to locally managed lesson study…

  5. Brazilian Clinical Trials Registry and the challenges for clinical research governance.

    Science.gov (United States)

    Laguardia, Josué; Piolli, Alessandro Luís; Prevot, Margareth; Ramalho, Luciano; Gamarski, Ricardo; Nishizawa, Claudio

    2011-01-01

    Over the past five years, efforts to set up a Brazilian clinical trials registry have progressed from early discussions in academic forums through to the establishment of the registry as a web-based computer platform. This article describes the process of developing and introducing the Brazilian Clinical Trials Registry (ReBEC), and its relationship with the authorities that regulate clinical research in Brazil. The Brazilian Clinical Trials Registry and the multilingual, free and open source, internet-based software developed to manage it are outcomes of partnerships among Brazilian federal and international health agencies. Information for describing the technical and operational dimensions of Rebec was drawn from technical documents and the records of the OpenTrials software development team and the ReBEC executive and advisory committees, which are available in free-access repositories. The Brazilian Clinical Trials Registry was launched in December 2010, and approved as a primary registry of the WHO ICTRP network in April 2011. ReBEC's arrival on-line and its acceptance as an ICTRP primary registry is a significant step in consolidating a policy of free access to information on clinical research in Brazil. © 2011 Blackwell Publishing Asia Pty Ltd and Chinese Cochrane Center, West China Hospital of Sichuan University.

  6. 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

  7. 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.

  8. 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.

  9. 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...

  10. 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...

  11. 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...

  12. 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

  13. 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

  14. 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

  15. Telemedicine Provides Noninferior 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

    2016-07-01

    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 was to determine whether patient comprehension of telemedicine-enabled research informed consent is noninferior to standard face-to-face (F2F) research informed consent. 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 noninferior comprehension compared with standard consent. This study was conducted as part of a parent clinical trial evaluating the effectiveness of 0.12% oral chlorhexidine gluconate 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 F2F consent. Telemedicine connectivity was provided using a commercially available interface (REACH platform, Vidyo Inc.) 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. A total of 131 patients were randomized (n = 64, telemedicine), and 101 QuIC surveys were completed. Comprehension of research informed consent using telemedicine was not inferior to F2F 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. Telemedicine is noninferior to F2F consent for delivering research informed consent, with no detected

  16. 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.

  17. 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.

  18. Race, medical researcher distrust, perceived harm, and willingness to participate in cardiovascular prevention trials.

    Science.gov (United States)

    Braunstein, Joel B; Sherber, Noëlle S; Schulman, Steven P; Ding, Eric L; Powe, Neil R

    2008-01-01

    Minority underrepresentation exists in medical research including cardiovascular clinical trials, but the hypothesis that this relates to distrust in medical researchers is unproven. Therefore, we examined whether African American persons differ from white persons in perceptions of the risks/benefits of trial participation and distrust toward medical researchers, and whether these factors influence willingness to participate (WTP) in a clinical drug trial. Participants were self-administered a survey regarding WTP in a cardiovascular drug trial given to 1440 randomly selected patients from 13 Maryland outpatient cardiology and general medicine clinics. Patients reported their WTP, rated their perceived chances of experiencing health benefit and harm, and rated their distrust toward researchers. Of eligible participants, 70% responded, and 717 individuals were included: 36% African American and 64% white. African American participants possessed lower WTP than white participants (27% vs. 39%, p = 0.001) and had higher mean distrust scores than whites (p prescribe medication as a way of experimenting on people without their knowledge (35% vs. 16%, p < 0.001), and ask them to participate in research even if it could harm them (24% vs. 15%, p = 0.002). African American participants also more often believed they could less freely ask their doctor questions (8% vs. 2%, p < 0.001) and that doctors had previously experimented on them without their consent (58% vs. 25%, p < 0.001). African American participants expressed lesser WTP than white participants after controlling for racial differences in age, sex, socioeconomic status and cardiovascular disease risk profiles (multivariable odds ratio [OR], 0.57; 95% confidence interval [CI], 0.39-0.85). The impact of race was attenuated and nonsignificant after adjustment for potential mediating factors of racial differences in medical researcher distrust and perceived risk of harm (explanatory model OR, 0.84; 95% CI 0

  19. 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.

  20. 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.

    2018-01-01

    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 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 (i.e., chronic post-surgical 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 (i.e., surgery, viral infection, injury, and toxic/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. PMID:25887465

  1. 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.

  2. 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

  3. 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...

  4. 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.

  5. 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, ...

  6. 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 ...

  7. Communicating BRCA research results to patients enrolled in international clinical trials

    DEFF Research Database (Denmark)

    Pulford, David J; Harter, Philipp; Floquet, Anne

    2016-01-01

    pharmacogenetic informed consent. Differences in local requirements, clinical practice, and opinion regarding the ethical aspects of how to convey genetic results to patients are all potential barriers to returning individual BRCA results to patients. Communicating the aggregate BRCA result from this study......BACKGROUND: The focus on translational research in clinical trials has the potential to generate clinically relevant genetic data that could have importance to patients. This raises challenging questions about communicating relevant genetic research results to individual patients. METHODS......: An exploratory pharmacogenetic analysis was conducted in the international ovarian cancer phase III trial, AGO-OVAR 16, which found that patients with clinically important germ-line BRCA1/2 mutations had improved progression-free survival prognosis. Mechanisms to communicate BRCA results were evaluated, because...

  8. 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

  9. 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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ...

  10. 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

  11. Nuclear disarmament verification

    Energy Technology Data Exchange (ETDEWEB)

    DeVolpi, A.

    1993-12-31

    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.

  12. 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

  13. 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

  14. 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

  15. 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

  16. Clinical Trials

    Medline Plus

    Full Text Available ... Back To Health Topics / About Clinical Trials About Clinical Trials Clinical trials are research studies that explore whether a medical ... is safe and effective for humans. What Are Clinical Trials? Clinical trials are research studies that explore whether ...

  17. 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/.

  18. Open verification methodology cookbook

    CERN Document Server

    Glasser, Mark

    2009-01-01

    Functional verification is an art as much as a science. It requires not only creativity and cunning, but also a clear methodology to approach the problem. The Open Verification Methodology (OVM) is a leading-edge methodology for verifying designs at multiple levels of abstraction. It brings together ideas from electrical, systems, and software engineering to provide a complete methodology for verifying large scale System-on-Chip (SoC) designs. OVM defines an approach for developing testbench architectures so they are modular, configurable, and reusable. This book is designed to help both novic

  19. Requirement Assurance: A Verification Process

    Science.gov (United States)

    Alexander, Michael G.

    2011-01-01

    Requirement Assurance is an act of requirement verification which assures the stakeholder or customer that a product requirement has produced its "as realized product" and has been verified with conclusive evidence. Product requirement verification answers the question, "did the product meet the stated specification, performance, or design documentation?". In order to ensure the system was built correctly, the practicing system engineer must verify each product requirement using verification methods of inspection, analysis, demonstration, or test. The products of these methods are the "verification artifacts" or "closure artifacts" which are the objective evidence needed to prove the product requirements meet the verification success criteria. Institutional direction is given to the System Engineer in NPR 7123.1A NASA Systems Engineering Processes and Requirements with regards to the requirement verification process. In response, the verification methodology offered in this report meets both the institutional process and requirement verification best practices.

  20. Clinical research activity in periodontal medicine: a systematic mapping of trial registers.

    Science.gov (United States)

    Monsarrat, Paul; Blaizot, Alessandra; Kémoun, Philippe; Ravaud, Philippe; Nabet, Cathy; Sixou, Michel; Vergnes, Jean-Noel

    2016-05-01

    The primary aim of the study was to systematically map registration records on periodontal medicine in clinical trial registers. The secondary aim was to assess the evolution of periodontal medicine in clinical periodontal research as a whole. We searched all registration records related to periodontology in the World Health Organization International Clinical Trials Registry Platform. For registration records classified in the field of periodontal medicine, we assigned the 2015 MeSH(®) term for the most precisely corresponding systemic condition. Fifty-seven systemic conditions have been hypothesized to be linked with periodontal diseases, covering nearly 2% of the diseases indexed in MeSH. In addition to diabetes, cardiovascular disease or preterm birth, other systemic conditions have been the subject of registration records, such as anaemia, liver diseases, dyspepsia or ankylosing spondylitis. A trend towards increasing diversification of systemic conditions has appeared over time. About a third of registration records in clinical periodontal research deals with periodontal medicine. Periodontal medicine now constitutes an important part of clinical periodontal research. Research activity in periodontal medicine has grown continuously since the early 2000s, and exploration of registers gives a useful up-to-date snapshot of this constantly evolving field of research. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

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

    Directory of Open Access Journals (Sweden)

    Stéphanie J.E. Becker

    2014-09-01

    Full Text Available Background:  The primary aim of this study was to determine predictors of missed research appointments in a prospective  andomized placebo injection-controlled trial with evaluations 1 to 3 and 5 to 8 months after enrollment.   Methods:  This study represents a secondary use of data from 104 patients that were enrolled in a prospective randomized  ontrolled trial of dexamethasone versus lidocaine (placebo injection for various diagnoses. Patients were enrolled between June 2003 and February 2008. Sixty-three patients (61% had lateral epicondylosis, 17 patients (16% had trapeziometacarpal arthrosis, and 24 patients (23% had de Quervain syndrome. Each patient completed a set of questionnaires at time of enrollment. Bivariable and multivariable analyses were used to determine factors associated with missed research appointments.  Results:  Fourteen patients (13% did not return for the first follow-up and 33 patients (32% did not return for the second follow-up. The best multivariable logistic regression model for missing the first research visit explained 35% of the variability and included younger age, belief that health can be controlled, and no college education. The best model for missing the second research visit explained 17% of the variability and included greater pain intensity, less personal responsibility for health, and diagnosis (trapeziometacarpal arthrosis and de Quervain syndrome. Conclusions:  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.

  2. Challenges in High-Assurance Runtime Verification

    Science.gov (United States)

    Goodloe, Alwyn E.

    2016-01-01

    Safety-critical systems are growing more complex and becoming increasingly autonomous. Runtime Verification (RV) has the potential to provide protections when a system cannot be assured by conventional means, but only if the RV itself can be trusted. In this paper, we proffer a number of challenges to realizing high-assurance RV and illustrate how we have addressed them in our research. We argue that high-assurance RV provides a rich target for automated verification tools in hope of fostering closer collaboration among the communities.

  3. Quantum Fully Homomorphic Encryption with Verification

    DEFF Research Database (Denmark)

    Alagic, Gorjan; Dulek, Yfke; Schaffner, Christian

    2017-01-01

    Fully-homomorphic encryption (FHE) enables computation on encrypted data while maintaining secrecy. Recent research has shown that such schemes exist even for quantum computation. Given the numerous applications of classical FHE (zero-knowledge proofs, secure two-party computation, obfuscation, etc.......) it is reasonable to hope that quantum FHE (or QFHE) will lead to many new results in the quantum setting. However, a crucial ingredient in almost all applications of FHE is circuit verification. Classically, verification is performed by checking a transcript of the homomorphic computation. Quantumly, this strategy...... is impossible due to no-cloning. This leads to an important open question: can quantum computations be delegated and verified in a non-interactive manner? In this work, we answer this question in the affirmative, by constructing a scheme for QFHE with verification (vQFHE). Our scheme provides authenticated...

  4. 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)…

  5. Cervix Cancer Research Network (CCRN): Improving Access to Cervix Cancer Trials on a Global Scale.

    Science.gov (United States)

    Gaffney, David; Small, Bill; Kitchener, Henry; Young Ryu, Sang; Viswanathan, Akila; Trimble, Ted; Covens, Al; Wilailak, Sarikapan; Lertkhachonsuk, Arb-Aroon; Sitathanee, Chomporn; Mahantshetty, Umesh; Fisher, Brandon; Springer, Susan; Pollatz, Thomas; Spiller, Antonius; Bacon, Monica; Jhingran, Anuja

    2016-11-01

    Eighty-seven percent of cervix cancer occurs in less-developed regions of the world, and there is up to an 18-fold difference in mortality rate for cervix cancer depending on the region of the world. The Cervix Cancer Research Network (CCRN) was founded through the Gynecologic Cancer InterGroup with the aim of improving access to clinical trials in cervix cancer worldwide, and in so doing improving standards of care. The CCRN recently held its first international educational symposium in Bangkok. Sixty-two participants attended from 16 different countries including Pakistan, India, Bangladesh, Thailand, Malaysia, Singapore, Philippines, Taiwan, China, Vietnam, Korea, Japan, Columbia, Brazil, Canada, and the United States. The focus of this symposium was to evaluate progress, to promote new clinical trials for the CCRN, and to provide education regarding the role of brachytherapy in the treatment of cervical cancer.

  6. 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.

  7. Runtime Verification for Decentralised and Distributed Systems

    NARCIS (Netherlands)

    Francalanza, Adrian; Pérez, Jorge A.; Sánchez, César; Bartocci, Ezio; Falcone, Yliès

    This chapter surveys runtime verification research related to distributed systems. We report solutions that study how to monitor system with some distributed characteristic, solutions that use a distributed platform for performing a monitoring task, and foundational works that present semantics for

  8. 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

  9. 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 systems * formal verification Subject RIV: IN - Informatics, Computer Science Impact factor: 1.250, year: 2012

  10. The experiences of pregnant women in an interventional clinical trial: Research In Pregnancy Ethics (RIPE) study.

    Science.gov (United States)

    Ballantyne, Angela; Pullon, Susan; Macdonald, Lindsay; Barthow, Christine; Wickens, Kristen; Crane, Julian

    2017-07-01

    There is increasing global pressure to ensure that pregnant women are responsibly and safely included in clinical research in order to improve the evidence base that underpins healthcare delivery during pregnancy. One supposed barrier to inclusion is the assumption that pregnant women will be reluctant to participate in research. There is however very little empirical research investigating the views of pregnant women. Their perspective on the benefits, burdens and risks of research is a crucial component to ensuring effective recruitment. The Research In Pregnancy Ethics (RIPE) study set out to ascertain the views of pregnant women about research participation using an inductive thematic analysis. We conducted semi-structured interviews with 20 women who had participated in a double-blind randomised placebo controlled trial in Wellington (New Zealand) while pregnant. Our results show that at least some pregnant women recognise the value and importance of research during pregnancy. The women we interviewed were deeply invested in the research process and outcomes. Key motivations for participating were altruism, playing a valuable civic role and the importance of research. The main perceived burdens related to inconvenience and time commitment. For some women, possible randomization to the placebo arm was regarded as a burden or disadvantage. © 2017 John Wiley & Sons Ltd.

  11. When is informed consent required in 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, we 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 second of the questions posed, namely, from whom, when, and how must informed consent be obtained in CRTs in health research? The ethical principle of respect for persons implies that researchers are generally obligated to obtain the informed consent of research subjects. Aspects of CRT design, including cluster randomization, cluster level interventions, and cluster size, present challenges to obtaining informed consent. Here we address five questions related to consent and CRTs: How can a study proceed if informed consent is not possible? Is consent to randomization always required? What information must be disclosed to potential subjects if their cluster has already been randomized? Is passive consent a valid substitute for informed consent? Do health professionals have a moral obligation to participate as subjects in CRTs designed to improve professional practice? We set out a framework based on the moral foundations of informed consent and international regulatory provisions to address each of these questions. First, when informed consent is not possible, a study may proceed if a research ethics committee is satisfied that conditions for a waiver of consent are satisfied. Second, informed consent to randomization may not be required if it is not possible to approach subjects at the time of randomization. Third, when potential subjects are approached after cluster randomization, they must be provided with a detailed description of the interventions in the trial arm to which their cluster has been randomized; detailed information on interventions in other trial arms need not be provided. Fourth, while passive consent may serve a variety of practical ends, it

  12. Sample size determinations in original research protocols for randomised clinical trials submitted to UK research ethics committees: review.

    Science.gov (United States)

    Clark, Timothy; Berger, Ursula; Mansmann, Ulrich

    2013-03-21

    To assess the completeness of reporting of sample size determinations in unpublished research protocols and to develop guidance for research ethics committees and for statisticians advising these committees. Review of original research protocols. Unpublished research protocols for phase IIb, III, and IV randomised clinical trials of investigational medicinal products submitted to research ethics committees in the United Kingdom during 1 January to 31 December 2009. Completeness of reporting of the sample size determination, including the justification of design assumptions, and disagreement between reported and recalculated sample size. 446 study protocols were reviewed. Of these, 190 (43%) justified the treatment effect and 213 (48%) justified the population variability or survival experience. Only 55 (12%) discussed the clinical importance of the treatment effect sought. Few protocols provided a reasoned explanation as to why the design assumptions were plausible for the planned study. Sensitivity analyses investigating how the sample size changed under different design assumptions were lacking; six (1%) protocols included a re-estimation of the sample size in the study design. Overall, 188 (42%) protocols reported all of the information to accurately recalculate the sample size; the assumed withdrawal or dropout rate was not given in 177 (40%) studies. Only 134 of the 446 (30%) sample size calculations could be accurately reproduced. Study size tended to be over-estimated rather than under-estimated. Studies with non-commercial sponsors justified the design assumptions used in the calculation more often than studies with commercial sponsors but less often reported all the components needed to reproduce the sample size calculation. Sample sizes for studies with non-commercial sponsors were less often reproduced. Most research protocols did not contain sufficient information to allow the sample size to be reproduced or the plausibility of the design assumptions to

  13. 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

  14. 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...

  15. MARATHON Verification (MARV)

    Science.gov (United States)

    2017-08-01

    the verification and "lessons learned " from the semantic and technical issues we discovered as we implemented the approach. 15. SUBJECT TERMS...any programming language at use at CAA for modeling or other data analysis applications, to include R, Python , Scheme, Common Lisp, Julia, Mathematica

  16. Efficient Source Data Verification Using Statistical Acceptance Sampling : A Simulation Study

    NARCIS (Netherlands)

    van den Bor, Rutger M.; Oosterman, Bas; Oostendorp, MB; Grobbee, Diederick E.; Roes, Kit C B

    2016-01-01

    Background: One approach to increase the efficiency of clinical trial monitoring is to replace 100% source data verification (SDV) by verification of samples of source data. An intuitive strategy for determining appropriate sampling plans (ie, sample sizes and the maximum tolerable number of

  17. 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.

  18. 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.

  19. 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.

  20. 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

  1. 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.

  2. 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.

  3. From question-behaviour effects in trials to the social psychology of research participation.

    Science.gov (United States)

    McCambridge, Jim

    2015-01-01

    The 'question-behaviour effect' (QBE) has attracted much recent attention within health psychology, where it has also been referred to as the 'mere measurement' effect. There are other conceptualisations of similar phenomena in related disciplines. This paper explores the implications of the QBE for the safety of inferences about intervention effectiveness within the context of randomised controlled trials evaluating health behaviour change interventions. It draws attention to poorly understood mechanisms by which bias is introduced with conventional thinking about trial design and analysis. The threat to valid inference on intervention effectiveness posed by the QBE applies even when its effects are small and regardless of the specific content of the QBE. The nature of the resulting bias does not fit well within existing bias classification schemes, such as that proposed by the Cochrane Collaboration. The QBE is one possible consequence of research participation and it is suggested that the social psychology of research participation is very much underdeveloped. Possible future directions for health psychology research in this area are considered.

  4. 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.

  5. 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 (VRC) at the NIH/National Institute of Allergy and Infectious Diseases (NIAID) responded to a call from Anthony Fauci, Ph.D., head, NIAID, to get a candidate vaccine into human trials by the summer of 2016.

  6. 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.

  7. Investigator-initiated trials of targeted oncology agents: why independent research is at risk?

    Science.gov (United States)

    Bergmann, L; Berns, B; Dalgleish, A G; von Euler, M; Hecht, T T; Lappin, G L; Reed, N; Palmeri, S; Smyth, J; Embacher-Aichorn, S; Zwierzina, H

    2010-08-01

    Drug development traditionally has relied upon the complementary contributions of clinicians and scientists at academic institutions and at pharmaceutical companies. Greater regulatory burdens, increased bureaucratic requirements, restricted reimbursement, and spiralling research and development costs are exerting pressure on the drug development pipeline. The result is a de-emphasis of exploratory research, particularly independent academic research, despite its proven value in identifying new drug targets and developing innovative cancer therapies. An expert panel assembled by the Biotherapy Development Association-a nonprofit international forum for academic and industry researchers, patients, and government regulatory and postregulatory agencies-examined the growing schism between academia and industry and identified several causes of declining academic research. The authors propose solutions to sustain investigator-initiated research and provide a new model whereby expert organisations provide a forum for academia and industry to plan studies within a regulatory framework to support licensure/authorisation and reimbursement for new molecularly targeted agents and biomarkers. Investigator-initiated trials have led to the discovery and development of innovative, safe, and effective cancer treatments. To ensure that such research continues, action will be required on the parts of legislative and regulatory bodies, industry, universities, patient advocacy organisations, and preclinical and clinical academic scientists.

  8. 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.

  9. Human dignity as a basis for providing post-trial access to healthcare for research participants: a South African perspective.

    Science.gov (United States)

    Andanda, Pamela; Wathuta, Jane

    2018-03-01

    This paper discusses the need to focus on the dignity of human participants as a legal and ethical basis for providing post-trial access to healthcare. Debate about post-trial benefits has mostly focused on access to products or interventions proven to be effective in clinical trials. However, such access may be modelled on a broad fair benefits framework that emphasises both collateral benefits and interventional products of research, instead of prescribed post-trial access alone (Legal and ethical regulation of biomedical research in developing countries p. 134, 2016). The wording of the current version of the Declaration of Helsinki could in fact be interpreted to broaden the scope to include other collateral benefits by applying such a broad fair benefits framework. We argue that this possibility should be utilised by low and middle income countries' (LMICs) health research ethics committees (RECs) in order to ensure that research participants who enrol in clinical trials so as to receive medical care continue to access care after the trial is concluded, as befits their dignity. Although each LMIC has unique concerns, nonetheless there are common challenges based especially on emerging issues, such as post-trial access to healthcare. Accordingly, the South African perspective is used to draw lessons that can benefit other LMICs.

  10. 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.

  11. 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. ...

  12. A Tutorial on Text-Independent Speaker Verification

    Directory of Open Access Journals (Sweden)

    Frédéric Bimbot

    2004-04-01

    Full Text Available This paper presents an overview of a state-of-the-art text-independent speaker verification system. First, an introduction proposes a modular scheme of the training and test phases of a speaker verification system. Then, the most commonly speech parameterization used in speaker verification, namely, cepstral analysis, is detailed. Gaussian mixture modeling, which is the speaker modeling technique used in most systems, is then explained. A few speaker modeling alternatives, namely, neural networks and support vector machines, are mentioned. Normalization of scores is then explained, as this is a very important step to deal with real-world data. The evaluation of a speaker verification system is then detailed, and the detection error trade-off (DET curve is explained. Several extensions of speaker verification are then enumerated, including speaker tracking and segmentation by speakers. Then, some applications of speaker verification are proposed, including on-site applications, remote applications, applications relative to structuring audio information, and games. Issues concerning the forensic area are then recalled, as we believe it is very important to inform people about the actual performance and limitations of speaker verification systems. This paper concludes by giving a few research trends in speaker verification for the next couple of years.

  13. Crowdsourced health research studies: an important emerging complement to clinical trials in the public health research ecosystem.

    Science.gov (United States)

    Swan, Melanie

    2012-03-07

    conditions. PatientsLikeMe and 23andMe are the leading operators of researcher-organized, crowdsourced health research studies. These operators have published findings in the areas of disease research, drug response, user experience in crowdsourced studies, and genetic association. Quantified Self, Genomera, and DIYgenomics are communities of participant-organized health research studies where individuals conduct self-experimentation and group studies. Crowdsourced health research studies have a diversity of intended outcomes and levels of scientific rigor. Participatory health initiatives are becoming part of the public health ecosystem and their rapid growth is facilitated by Internet and social networking influences. Large-scale parameter-stratified cohorts have potential to facilitate a next-generation understanding of disease and drug response. Not only is the large size of crowdsourced cohorts an asset to medical discovery, too is the near-immediate speed at which medical findings might be tested and applied. Participatory health initiatives are expanding the scope of medicine from a traditional focus on disease cure to a personalized preventive approach. Crowdsourced health research studies are a promising complement and extension to traditional clinical trials as a model for the conduct of health research.

  14. 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.

  15. Pragmatic (trial) informatics: a perspective from the NIH Health Care Systems Research Collaboratory.

    Science.gov (United States)

    Richesson, Rachel L; Green, Beverly B; Laws, Reesa; Puro, Jon; Kahn, Michael G; Bauck, Alan; Smerek, Michelle; Van Eaton, Erik G; Zozus, Meredith; Hammond, W Ed; Stephens, Kari A; Simon, Greg E

    2017-09-01

    Pragmatic clinical trials (PCTs) are research investigations embedded in health care settings designed to increase the efficiency of research and its relevance to clinical practice. The Health Care Systems Research Collaboratory, initiated by the National Institutes of Health Common Fund in 2010, is a pioneering cooperative aimed at identifying and overcoming operational challenges to pragmatic research. Drawing from our experience, we present 4 broad categories of informatics-related challenges: (1) using clinical data for research, (2) integrating data from heterogeneous systems, (3) using electronic health records to support intervention delivery or health system change, and (4) assessing and improving data capture to define study populations and outcomes. These challenges impact the validity, reliability, and integrity of PCTs. Achieving the full potential of PCTs and a learning health system will require meaningful partnerships between health system leadership and operations, and federally driven standards and policies to ensure that future electronic health record systems have the flexibility to support research. © The Author 2017. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  16. 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.

  17. Prospective validation of the Bleeding Academic Research Consortium classification in the all-comer PRODIGY trial.

    Science.gov (United States)

    Vranckx, Pascal; Leonardi, Sergio; Tebaldi, Matteo; Biscaglia, Simone; Parrinello, Giovanni; Rao, Sunil V; Mehran, Roxana; Valgimigli, Marco

    2014-10-01

    The Bleeding Academic Research Consortium (BARC) classification has been proposed by consensus to standardize bleeding endpoint definition and reporting in cardiovascular clinical trials. There are no prospective studies on its prognostic impact. We explored the association of BARC-defined bleeding with mortality and compared its prognostic value against two validated bleeding scales: the Thrombolysis in Myocardial Infarction (TIMI) and the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries (GUSTO) scales. Non-coronary artery bypass graft (CABG)-related bleedings within the PRODIGY trial were prospectively adjudicated by a blinded Clinical Event Committee and analysed according to multiple statistical modelling. At 2 years, bleeding occurred in 143 patients (7.1%) according to BARC Type 2, 3, or 5; in 50 patients (2.5%) according to TIMI minor or major; and in 61 patients (3.1%) according to GUSTO moderate or severe. One hundred sixty-three patients died (8.1%). After multivariable modelling, BARC Type 2, 3, or 5 bleeding was associated with increased 2-year mortality [hazard ratio (HR): 3.77; 95% confidence interval (CI): 2.37-5.98]. Bleeding Academic Research Consortium Type 3 or 5 was associated with an increased mortality rate at 2 years (adjusted HR: 7.72; 95% CI: 4.75-12.54) similar to that provided by TIMI (HR: 7.64, 95% CI: 4.53-12.87) or GUSTO (HR: 7.36, 95% CI: 4.38-12.34) criteria. In a contemporary, all-comer percutaneous coronary intervention trial actionable BARC bleedings were associated with increased risk of mortality with BARC Type 3 or 5 bleedings providing a similar mortality risk to that posed by TIMI or GUSTO scales. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2014. For permissions please email: journals.permissions@oup.com.

  18. Clinical Trials

    Medline Plus

    Full Text Available ... clinical trials. The NIH may partner with these companies or groups to help sponsor some trials. All types of clinical trials contribute to medical knowledge and practice. Why Clinical Trials Are Important Clinical trials are a key research tool for advancing medical knowledge and patient ...

  19. 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.

  20. Using ClinicalTrials.gov to understand the state of clinical research in pulmonary, critical care, and sleep medicine.

    Science.gov (United States)

    Todd, Jamie L; White, Kyle R; Chiswell, Karen; Tasneem, Asba; Palmer, Scott M

    2013-10-01

    ClinicalTrials.gov is the largest trial registry in the world. Strengthened registration requirements, including federal mandates in 2007, have increased study representation. A systematic evaluation of all registered studies has been limited by the absence of an aggregate data set and specialty-specific search terms. We leveraged a newly transformed database containing annotated data from ClinicalTrials.gov to define the portfolio of interventional clinical research in pulmonary, critical care, and sleep medicine. Analysis was restricted to studies registered after September 2007 through September 2010 and defined as "interventional" (n = 40,970). A specialty-specific study data set (n = 2,226) was created using disease condition terms provided by data submitters and medical subject heading terms generated by a National Library of Medicine algorithm. Trial characteristics were extracted and summarized using descriptive statistics. Pulmonary, critical care, and sleep medicine trials composed 5.4% of all interventional studies registered over the 3-year period. In contrast, oncology and cardiovascular disease composed 21.9 and 8.4% of trials, respectively. Within pulmonary trials, asthma and chronic obstructive pulmonary disease were the most studied conditions (27.4 and 21.8% of studies, respectively), and measures of lung function or safety were the most frequent primary outcomes. Nearly two-thirds of trials indicated enrollment of 100 patients or fewer, and a majority of studies were phase II or III trials. The single largest funding source (43.5%) was industry, and study characteristics varied by funding source. We applied a novel approach to describe the portfolio of interventional clinical research in pulmonary medicine. Our results indicate a disparity between trial representation and the burden of respiratory disease. Resources should be targeted across the spectrum of pulmonary research to address this discrepancy.

  1. The institutional development award states pediatric clinical trials network: building research capacity among the rural and medically underserved.

    Science.gov (United States)

    Snowden, Jessica; Darden, Paul; Palumbo, Paul; Saul, Phil; Lee, Jeannette

    2018-04-01

    The institutional development award (IDeA) program was created to increase the competitiveness of investigators in states with historically low success rates for National Institutes of Health (NIH) research funding applications. IDeA states have high numbers of rural and medically underserved residents with disproportionately high rates of infant mortality, obesity, and poverty. This program supports the development and expansion of research infrastructure and research activities in these states. The IDeA States Pediatric Clinical Trials Network (ISPCTN) is part of the environmental influences on child health outcomes program. Its purpose is to build research capacity within IDeA states and provide opportunities for children in IDeA states to participate in clinical trials. This review describes the current and future activities of the network. In its initial year, the ISPCTN created an online series on clinical trials, initiated participation in a study conducted by the pediatric trials network, and proposed two novel clinical trials for obese children. Capacity building and clinical trial implementation will continue in future years. The ISPCTN is uniquely poised to establish and support new pediatric clinical research programs in underserved populations, producing both short and long-term gains in the understanding of child health.

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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.)

  7. 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

  8. 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.

  9. 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

  10. The National Drug Abuse Treatment Clinical Trials Network: forging a partnership between research knowledge and community practice

    Directory of Open Access Journals (Sweden)

    Liu D

    2011-03-01

    Full Text Available Betty Tai, Steven Sparenborg, David Liu, Michele StrausCenter for the Clinical Trials Network, National Institute on Drug Abuse, National Institutes of Health, United States Department of Health and Human Services, Bethesda, MD, USAAbstract: The National Drug Abuse Treatment Clinical Trials Network (CTN has faced many challenges over its first eleven years. This review explores some of these challenges and the paths the CTN took to meet these challenges, including: designing clinical trials that reflect the CTN’s mission and changing public health needs, finding the synergies in the varied expertise of clinical treatment providers and academic researchers, promoting evidence-based practices and expanding the Network into mainstream medical practices to reach a broader patient population. Included in this exploration are specific examples from CTN clinical trials.Keywords: Clinical Trials Network, drug abuse, addiction 

  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

    2011-01-01

    Background 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. Purpose 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. Methods 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 six 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. Results 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. Limitations Methodological challenges were encountered in the areas of site recruitment, participant recruitment, testing, and intervention delivery. Conclusions 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

  12. Design of a Web-tool for diagnostic clinical trials handling medical imaging research.

    Science.gov (United States)

    Baltasar Sánchez, Alicia; González-Sistal, Angel

    2011-04-01

    New clinical studies in medicine are based on patients and controls using different imaging diagnostic modalities. Medical information systems are not designed for clinical trials employing clinical imaging. Although commercial software and communication systems focus on storage of image data, they are not suitable for storage and mining of new types of quantitative data. We sought to design a Web-tool to support diagnostic clinical trials involving different experts and hospitals or research centres. The image analysis of this project is based on skeletal X-ray imaging. It involves a computerised image method using quantitative analysis of regions of interest in healthy bone and skeletal metastases. The database is implemented with ASP.NET 3.5 and C# technologies for our Web-based application. For data storage, we chose MySQL v.5.0, one of the most popular open source databases. User logins were necessary, and access to patient data was logged for auditing. For security, all data transmissions were carried over encrypted connections. This Web-tool is available to users scattered at different locations; it allows an efficient organisation and storage of data (case report form) and images and allows each user to know precisely what his task is. The advantages of our Web-tool are as follows: (1) sustainability is guaranteed; (2) network locations for collection of data are secured; (3) all clinical information is stored together with the original images and the results derived from processed images and statistical analysis that enable us to perform retrospective studies; (4) changes are easily incorporated because of the modular architecture; and (5) assessment of trial data collected at different sites is centralised to reduce statistical variance.

  13. 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

  14. The PROblem Gambling RESearch Study (PROGRESS) research protocol: a pragmatic randomised controlled trial of psychological interventions for problem gambling.

    Science.gov (United States)

    Thomas, Shane A; Merkouris, Stephanie S; Browning, Colette J; Radermacher, Harriet; Feldman, Susan; Enticott, Joanne; Jackson, Alun C

    2015-11-24

    International prevalence rates for problem gambling are estimated at 2.3%. Problem gambling is a serious global public health concern due to adverse personal and social consequences. Previous research evaluating the effectiveness of psychological interventions for the treatment of problem gambling has been compromised by methodological limitations, including small sample sizes and the use of waitlist control groups. This article describes the study protocol for a pragmatic randomised controlled trial (RCT) evaluating the effectiveness of cognitive-behavioural therapy (CBT), behaviour therapy (BT), motivational interviewing (MI) against a non-directive supportive therapy (NDST) control, in treating problem gambling. This study was a mixed-methods design, with a parallel group, pragmatic RCT as the primary component, and embedded qualitative studies conducted alongside. A total of 297 participants were recruited from the community in Victoria, Australia. Individuals aged 18 years and over, could communicate in English and wished to receive treatment for a gambling problem were eligible. Participants were randomly allocated in to 1 of the 4 psychological interventions: CBT, BT, MI and NDST. Repeated measures were conducted at pretreatment and post-treatment, and 6 and 12 months post-treatment. The statistical analysis will use an intention-to-treat approach. Multilevel mixed modelling will be used to examine changes in the primary outcome measures: gambling symptom severity, using the Gambling Symptom Assessment Scale, and gambling behaviours (frequency, time and expenditure). Secondary outcomes are depression, anxiety, stress and alcohol use. Individual semistructured qualitative interviews were conducted at pretreatment and post-treatment and 12 months post-treatment for a subset of participants (n=66). This study was approved by the Victorian Department of Justice, Monash University and the University of Melbourne Human Research Ethics Committees. Findings

  15. 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

  16. 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

  17. 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.

  18. 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.

  19. Secondary distress in violence researchers: a randomised trial of the effectiveness of group debriefings.

    Science.gov (United States)

    Grundlingh, Heidi; Knight, Louise; Naker, Dipak; Devries, Karen

    2017-06-02

    Secondary distress including emotional distress, vicarious trauma (VT) and secondary traumatic stress (STS) due to exposure to primary trauma victims have been described in helping professionals and in violence researchers. To our knowledge, there are few prevalence studies, and no tailored interventions have been tested to reduce secondary distress in violence researchers. The study aims to (1) describe the epidemiology of secondary distress experienced by violence researchers; to (2) assess the effectiveness of group debriefings in mitigating secondary distress; to (3) assess risk and protective factors. We conducted an un-blinded, individually randomised trial with parallel assignment. Eligible participants were 59 Ugandan researchers employed by the Good Schools Study to interview children who experienced violence in a district of Uganda. Fifty-three researchers agreed to participate and were randomly allocated. The intervention group (n = 26) participated in three group debriefings and the control group (n = 27) in three leisure sessions (film viewings). The primary outcome was change in levels of emotional distress (SRQ-20); secondary outcomes were levels of VT and STS at end-line. A paired t-test assessed the difference in mean baseline and end-line emotional distress. Un-paired t-tests compared the change in mean emotional distress (baseline vs. end-line), and compared levels of VT and STS at end-line. Separate logistic regression models tested the association between end-line emotional distress and a-priori risk or protective factors. Baseline and end-line levels of emotional distress were similar in control (p = 0.47) and intervention (p = 0.59) groups. The superiority of group debriefing over leisure activities in lowering levels of emotional distress in the intervention group (n = 26; difference in SRQ-20 = 0.23 [SD = 2.18]) compared to the control group (n = 26; difference in SRQ-20 = 0.23 [SD = 1.63]) could not be detected (p = 1

  20. 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.

  1. 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

  2. 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)

  3. Barriers to medical research participation as perceived by clinical trial investigators: communicating with rural and african american communities.

    Science.gov (United States)

    Tanner, Andrea; Kim, Sei-Hill; Friedman, Daniela B; Foster, Caroline; Bergeron, Caroline D

    2015-01-01

    Clinical trials help advance public health and medical research on prevention, diagnosis, screening, treatment, and quality of life. Despite the need for access to quality care in medically underserved areas, clinical trial participation remains low among individuals in rural and African American communities. This study assessed clinical trial research in South Carolina's five main academic medical centers, focusing specifically on clinical trial investigators' perceived barriers to recruitment in the general population and in rural and African American communities. Online survey responses (N = 119) revealed that it was most difficult for investigators to recruit from rural areas and that rural residents were least likely to be represented in medical research, behind both the general public and African Americans. Barriers focusing on communication or awareness proved to be the biggest hurdles to finding potential participants in both the general public and rural communities. Psychological barriers to recruitment were perceived to be most prevalent in African American communities. Study findings provide important insights from the perspective of the clinical trial investigator that will aid in the development of effective communication and education strategies for reaching rural and African American residents with information about clinical trials.

  4. 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

  5. Parking Space Verification

    DEFF Research Database (Denmark)

    Høg Peter Jensen, Troels; Thomsen Schmidt, Helge; Dyremose Bodin, Niels

    2018-01-01

    With the number of privately owned cars increasing, the issue of locating an available parking space becomes apparant. This paper deals with the verification of vacant parking spaces, by using a vision based system looking over parking areas. In particular the paper proposes a binary classifier...... system, based on a Convolutional Neural Network, that is capable of determining if a parking space is occupied or not. A benchmark database consisting of images captured from different parking areas, under different weather and illumination conditions, has been used to train and test the system...

  6. 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

  7. 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 ...

  8. 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 ...

  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. 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 ...

  11. 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

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

    Directory of Open Access Journals (Sweden)

    Elena A. Spieker

    2015-01-01

    Full Text Available 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.

  13. 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.

  14. 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.

  15. Revised Final Report - Independent Verification Survey Activities At The Separations Process Research Unit Sites, Niskayuna, New York - DCN 0496-SR-06-1

    International Nuclear Information System (INIS)

    Harpeneau, Evan

    2011-01-01

    The Separations Process Research Unit (SPRU) complex located on the Knolls Atomic Power Laboratory (KAPL) site in Niskayuna, New York, was constructed in the late 1940s to research the chemical separation of plutonium and uranium (Figure A-1). SPRU operated as a laboratory scale research facility between February 1950 and October 1953. The research activities ceased following the successful development of the reduction oxidation and plutonium/uranium extraction processes. The oxidation and extraction processes were subsequently developed for large scale use by the Hanford and Savannah River sites (aRc 2008a). Decommissioning of the SPRU facilities began in October 1953 and continued through the 1990s.

  16. REVISED FINAL REPORT – INDEPENDENT VERIFICATION SURVEY ACTIVITIES AT THE SEPARATIONS PROCESS RESEARCH UNIT SITES, NISKAYUNA, NEW YORK – DCN 0496-SR-06-1

    Energy Technology Data Exchange (ETDEWEB)

    Evan Harpenau

    2011-10-10

    The Separations Process Research Unit (SPRU) complex located on the Knolls Atomic Power Laboratory (KAPL) site in Niskayuna, New York, was constructed in the late 1940s to research the chemical separation of plutonium and uranium (Figure A-1). SPRU operated as a laboratory scale research facility between February 1950 and October 1953. The research activities ceased following the successful development of the reduction oxidation and plutonium/uranium extraction processes. The oxidation and extraction processes were subsequently developed for large scale use by the Hanford and Savannah River sites (aRc 2008a). Decommissioning of the SPRU facilities began in October 1953 and continued through the 1990s.

  17. Research Professionals' Perspectives, Barriers, and Recommendations Regarding Minority Participation in Clinical Trials.

    Science.gov (United States)

    Kurt, Anita; Semler, Lauren; Meyers, Matthew; Porter, Bernadette G; Jacoby, Jeanne L; Stello, Brian

    2017-12-01

    This study aims to investigate research professionals' perspectives regarding minority participation in clinical trials. A web-based survey of research professionals at US institutions receiving NIH and/or AHRQ funding to conduct clinical research in 2013. Descriptive statistics, mean, standard deviation (SD), and the Wilcoxon rank-sum test were utilized for analysis. Distributed were 13,041 surveys with 967 (7.4%) responses. Overall and race-stratified analyses included 633 and 521 surveys, respectively. A majority agreed that patients' race (mean, 3.4; SD = 1.0) and primary language (mean, 4.0; SD = 0.9) have an effect on enrollment. They had more success in enrolling those whose primary language was the same as their own (mean, 3.8; SD = 1.0), and that a language barrier and time spent arranging for interpreters had prevented them from offering a study to potential candidates (mean, 3.2; SD = 1.2). Non-Caucasian respondents were more likely to agree that "fear of unknown side effects" was a deterrent for minorities (p < 0.01), "minorities are more likely to be unavailable for follow-up phone calls" (p = 0.07), and "the unavailability of translated material discourages non-English speakers from participation" (p = 0.08). They also were more likely to be neutral or agree with being discouraged from enrolling minorities because of the possibility of their withdrawal or being less likely to be available for phone follow-ups and follow-up visits (all p < 0.01). Despite a few subtle racial differences in research professionals' perspectives, a majority expressed no hesitation in enrolling minorities. Patients' race and primary language appeared to influence enrollment. A language barrier appeared to be the strongest barrier for research professionals.

  18. 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

  19. 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

  20. 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...

  1. Fingerprint changes and verification failure among patients with hand dermatitis.

    Science.gov (United States)

    Lee, Chew Kek; Chang, Choong Chor; Johar, Asmah; Puwira, Othman; Roshidah, Baba

    2013-03-01

    To determine the prevalence of fingerprint verification failure and to define and quantify the fingerprint changes associated with fingerprint verification failure. Case-control study. Referral public dermatology center. The study included 100 consecutive patients with clinical hand dermatitis involving the palmar distal phalanx of either thumb and 100 age-, sex-, and ethnicity-matched controls. Patients with an altered thumb print due to other causes and palmar hyperhidrosis were excluded. Fingerprint verification(pass/fail) and hand eczema severity index score. Twenty-seven percent of patients failed fingerprint verification compared with 2% of controls. Fingerprint verification failure was associated with a higher hand eczema severity index score (P.001). The main fingerprint abnormalities were fingerprint dystrophy (42.0%) and abnormal white lines (79.5%). The number of abnormal white lines was significantly higher among the patients with hand dermatitis compared with controls(P=.001). Among the patients with hand dermatitis, theodds of failing fingerprint verification with fingerprint dystrophy was 4.01. The presence of broad lines and long lines was associated with a greater odds of fingerprint verification failure (odds ratio [OR], 8.04; 95% CI, 3.56-18.17 and OR, 2.37; 95% CI, 1.31-4.27, respectively),while the presence of thin lines was protective of verification failure (OR, 0.45; 95% CI, 0.23-0.89). Fingerprint verification failure is a significant problem among patients with more severe hand dermatitis. It is mainly due to fingerprint dystrophy and abnormal white lines. Malaysian National Medical Research Register Identifier: NMRR-11-30-8226

  2. Lumbar Disk Herniation in the Spine Patient Outcomes Research Trial (SPORT): Does Educational Attainment Impact Outcome?

    Science.gov (United States)

    Olson, Patrick R.; Lurie, Jon D.; Frymoyer, John; Walsh, Thomas; Zhao, Wenyan; Abdu, William A.; Weinstein, James N.

    2011-01-01

    Study Design Randomized trial with concurrent observational cohort. 1171 patients were divided into subgroups by educational attainment: high school or less, some college, and college degree or above. Objective To assess the influence of education level on outcomes for treatment of lumbar disk herniation. Summary of Background Data Educational attainment has been demonstrated to have an inverse relationship with pain perception, co-morbidities, and mortality. Methods The Spine Patient Outcomes Research Trial enrolled surgical candidates (imaging-confirmed disk herniation with at least 6 weeks of persistent signs and symptoms of radiculopathy) from 13 multidisciplinary spine clinics in 11 US states. Treatments were standard open diskectomy vs. non-operative treatment. Outcomes were changes from baseline for SF-36 bodily pain (BP) and physical function (PF) scales and the modified Oswestry Disability Index (ODI) at 6 weeks, 3 months, 6 months, and yearly through 4 years. Results Substantial improvement was seen in all patient cohorts. Surgical outcomes did not differ by level of education. For non-operative outcomes, however, higher levels of education were associated with significantly greater overall improvement over 4 years in BP (p=0.007), PF (p=0.001) and ODI (p=0.003). At 4 years a “dose-response” type relationship was shown for BP (high school or less 25.5; some college 31; college graduate or above 36.3; p= 0.004); results were similar for PF and ODI. The success of non-operative treatment in the more educated cohort resulted in an attenuation of the relative benefit of surgery. Conclusions Patients with higher educational attainment demonstrated significantly greater improvement with non-operative treatment while educational attainment was not associated with surgical outcomes. PMID:21311402

  3. 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.

  4. Flexible trial design in practice - stopping arms for lack-of-benefit and adding research arms mid-trial in STAMPEDE: a multi-arm multi-stage randomized controlled trial.

    Science.gov (United States)

    Sydes, Matthew R; Parmar, Mahesh K B; Mason, Malcolm D; Clarke, Noel W; Amos, Claire; Anderson, John; de Bono, Johann; Dearnaley, David P; Dwyer, John; Green, Charlene; Jovic, Gordana; Ritchie, Alastair W S; Russell, J Martin; Sanders, Karen; Thalmann, George; James, Nicholas D

    2012-09-15

    Systemic Therapy for Advanced or Metastatic Prostate cancer: Evaluation of Drug Efficacy (STAMPEDE) is a randomized controlled trial that follows a novel multi-arm, multi-stage (MAMS) design. We describe methodological and practical issues arising with (1) stopping recruitment to research arms following a pre-planned intermediate analysis and (2) adding a new research arm during the trial. STAMPEDE recruits men who have locally advanced or metastatic prostate cancer who are starting standard long-term hormone therapy. Originally there were five research and one control arms, each undergoing a pilot stage (focus: safety, feasibility), three intermediate 'activity' stages (focus: failure-free survival), and a final 'efficacy' stage (focus: overall survival). Lack-of-sufficient-activity guidelines support the pairwise interim comparisons of each research arm against the control arm; these pre-defined activity cut-off becomes increasingly stringent over the stages. Accrual of further patients continues to the control arm and to those research arms showing activity and an acceptable safety profile. The design facilitates adding new research arms should sufficiently interesting agents emerge. These new arms are compared only to contemporaneously recruited control arm patients using the same intermediate guidelines in a time-delayed manner. The addition of new research arms is subject to adequate recruitment rates to support the overall trial aims. (1) Stopping Existing Therapy: After the second intermediate activity analysis, recruitment was discontinued to two research arms for lack-of-sufficient activity. Detailed preparations meant that changes were implemented swiftly at 100 international centers and recruitment continued seamlessly into Activity Stage III with 3 remaining research arms and the control arm. Further regulatory and ethical approvals were not required because this was already included in the initial trial design.(2) Adding New Therapy: An application to

  5. 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

  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. Clinical Trials

    Medline Plus

    Full Text Available ... list of NHLBI-sponsored clinical trials. NIH Clinical Research Studies Search for studies conducted within other Institutes at the NIH, including trials performed on our campus or trials NIH has sponsored at universities, medical centers, and hospitals. ClinicalTrials.gov View a ...

  8. Formal Development and Verification of Railway Control Systems

    DEFF Research Database (Denmark)

    Vu Hong, Linh; Haxthausen, Anne Elisabeth; Peleska, Jan

    standards [2] for railways to use formal (i.e. mathematical) logic and models for the unambiguous description of requirements and designs as well as for exhaustive verification as they give a higher assurance of safety compared to conventional methods. The use of domain-specific methods is another trend...... can be combined and used for an efficient development and verification of new fail-safe systems. The expected result is a methodology for using domain-specific, formal languages, techniques and tools for more efficient development and verification of robust software for railway control systems......This paper presents work package WP4.1 of the RobustRails research project. The work package aims at suggesting a methodology for efficient development and verification of safe and robust railway control systems. 1 Project background and state of the art Over the next 10 years all Danish railway...

  9. 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.

  10. Multimedia Consent for Research in People With Schizophrenia and Normal Subjects: a Randomized Controlled Trial

    Science.gov (United States)

    Jeste, Dilip V.; Palmer, Barton W.; Golshan, Shahrokh; Eyler, Lisa T.; Dunn, Laura B.; Meeks, Thomas; Glorioso, Danielle; Fellows, Ian; Kraemer, Helena; Appelbaum, Paul S.

    2009-01-01

    Limitations of printed, text-based, consent forms have long been documented and may be particularly problematic for persons at risk for impaired decision-making capacity, such as those with schizophrenia. We conducted a randomized controlled comparison of the effectiveness of a multimedia vs routine consent procedure (augmented with a 10-minute control video presentation) as a means of enhancing comprehension among 128 middle-aged and older persons with schizophrenia and 60 healthy comparison subjects. The primary outcome measure was manifest decisional capacity (understanding, appreciation, reasoning, and expression of choice) for participation in a (hypothetical) clinical drug trial, as measured with the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR) and the University of California San Diego (UCSD) Brief Assessment for Capacity to Consent (UBACC). The MacCAT-CR and UBACC were administered by research assistants kept blind to consent condition. Additional assessments included standardized measures of psychopathology and cognitive functioning. Relative to patients in the routine consent condition, schizophrenia patients receiving multimedia consent had significantly better scores on the UBACC and on the MacCAT-CR understanding and expression of choice subscales and were significantly more likely to be categorized as being capable to consent than those in the routine consent condition (as categorized with several previously established criteria). Among the healthy subjects, there were few significant effects of consent condition. These findings suggest that multimedia consent procedures may be a valuable consent aid that should be considered for use when enrolling participants at risk for impaired decisional capacity, particularly for complex and/or high-risk research protocols. PMID:18245061

  11. 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.

  12. 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.

  13. Sensor-fusion-based biometric identity verification

    Energy Technology Data Exchange (ETDEWEB)

    Carlson, J.J.; Bouchard, A.M.; Osbourn, G.C.; Martinez, R.F.; Bartholomew, J.W. [Sandia National Labs., Albuquerque, NM (United States); Jordan, J.B.; Flachs, G.M.; Bao, Z.; Zhu, L. [New Mexico State Univ., Las Cruces, NM (United States). Electronic Vision Research Lab.

    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.

  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. 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.

  16. 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...

  17. A pragmatic comparison of noise burst and electric shock unconditioned stimuli for fear conditioning research with many trials.

    Science.gov (United States)

    Sperl, Matthias F J; Panitz, Christian; Hermann, Christiane; Mueller, Erik M

    2016-09-01

    Several methods that are promising for studying the neurophysiology of fear conditioning (e.g., EEG, MEG) require a high number of trials to achieve an adequate signal-to-noise ratio. While electric shock and white noise burst are among the most commonly used unconditioned stimuli (US) in conventional fear conditioning studies with few trials, it is unknown whether these stimuli are equally well suited for paradigms with many trials. Here, N = 32 participants underwent a 260-trial differential fear conditioning and extinction paradigm with a 240-trial recall test 24 h later and neutral faces as conditioned stimuli. In a between-subjects design, either white noise bursts (n = 16) or electric shocks (n = 16) served as US, and intensities were determined using the most common procedure for each US (i.e., a fixed 95 dB noise burst and a work-up procedure for electric shocks, respectively). In addition to differing US types, groups also differed in closely linked US-associated characteristics (e.g., calibration methods, stimulus intensities, timing). Subjective ratings (arousal/valence), skin conductance, and evoked heart period changes (i.e., fear bradycardia) indicated more reliable, extinction-resistant, and stable conditioning in the white noise burst versus electric shock group. In fear conditioning experiments where many trials are presented, white noise burst should serve as US. © 2016 Society for Psychophysiological Research.

  18. Forming a national multicentre collaboration to conduct clinical trials: increasing high-quality research in the drug and alcohol field.

    Science.gov (United States)

    Sanson-Fisher, Rob; Brand, Matthew; Shakeshaft, Anthony; Haber, Paul; Day, Carolyn; Conigrave, Katherine; Mattick, Richard; Lintzeris, Nicholas; Teesson, Maree

    2010-09-01

    There is a shortage of high-quality intervention-based evidence in the drug and alcohol misuse field. That is, evidence based on replicated effects using rigorous methodology, to establish a causal knowledge base around ethical, cost-effective methods relevant to clinical practice. The knowledge base in this field is limited participant recruitment challenges; difficulty generalizing results from single-centre studies; lack of research culture; issues in managing research teams; incentives for descriptive research; and limited expertise in research design and working in multidisciplinary teams. An Australian national multicentre collaboration is proposed to overcome these barriers, and reduce the burden of drug and alcohol misuse by increasing the number of high-quality clinical trials in this field. It would involve: selecting a representative sample of centres nation-wide with expertise in specific drug and alcohol issues; creating an expert multidisciplinary team to facilitate clinical trials; simultaneous recruitment and implementation of clinical trials across centres; establishing a virtual infrastructure; forming an independent data-integrity and methodology review panel; and attracting and allocating funding for clinical trials. The ability to allocate funding, the involvement of multidisciplinary experts in drug and alcohol research, and the establishment of infrastructure and procedures are likely to result in the national multicentre group's capacity to prescribe the type of research conducted under its auspices. The proposed initiative is likely to increase the volume of high-quality clinical trials in the Australian drug and alcohol field, a key step towards reducing the burden of drug and alcohol misuse.

  19. Efficient Data Integrity Verification Using CRC Based on HDFS in Cloud Storage

    Directory of Open Access Journals (Sweden)

    Xia Yun-Hao

    2017-01-01

    Full Text Available Data integrity verification is becoming a major challenge in cloud storage which can’t be ignored. This paper proposes an optimized variant of CRC (Checker Redundancy Cyclic verification algorithm based on HDFS to improve the efficiency of data integrity verification in cloud storage through the research of CRC checksum algorithm and data integrity verification mechanism of HDFS. A new method is formulated to establish the deformational optimization and to accelerate the algorithm by researching characteristics of generating and checking the algorithm. Moreover, this method optimizes the code to improve the computational efficiency according to data integrity verification mechanism of HDFS. A data integrity verification system based on Hadoop is designed to verify proposed method. Experimental results demonstrate that proposed HDFS based CRC algorithm was able to improve the calculation efficiency and the utilization of system resource on the whole and outperformed well compared to existing models in terms of accuracy and time.

  20. New clinical trial tests prime-and-boost vaccine delivery for advanced solid tumors | Center for Cancer Research

    Science.gov (United States)

    Researchers are testing a prime-and-boost approach to safely direct the immune system to kill tumor cells that express brachyury, a protein expressed in high levels in some cancers. A new clinical trial is testing an experimental vaccine in patients whose cancers have not responded to standard treatments.

  1. Amyloid-related imaging abnormalities in amyloid-modifying therapeutic trials: Recommendations from the Alzheimer's Association Research Roundtable Workgroup

    NARCIS (Netherlands)

    Sperling, R.A.; Jack, C.R.; Black, S.E.; Frosch, M.P.; Greenberg, S.M.; Hyman, B.T.; Scheltens, P.; Carrillo, M.C.; Thies, W.; Bednar, M.M.; Black, R.S.; Brashear, H.R.; Grundman, M.; Siemers, E.R.; Feldman, H.H.; Schindler, R.J.

    2011-01-01

    Amyloid imaging related abnormalities (ARIA) have now been reported in clinical trials with multiple therapeutic avenues to lower amyloid-β burden in Alzheimer's disease (AD). In response to concerns raised by the Food and Drug Administration, the Alzheimer's Association Research Roundtable convened

  2. Milestones in Medical Research, The Human Genome and ClinicalTrials.gov | NIH MedlinePlus the Magazine

    Science.gov (United States)

    ... turn Javascript on. Milestones in Medical Research, The Human Genome and ClinicalTrials.gov Past Issues / Fall 2010 Table of Contents Donald West King, M.D. FNLM ... genetic foundation of all human beings; the second, a comprehensive information service to ...

  3. 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.

  4. 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.

  5. 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)

  6. 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.

  7. 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

  8. 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...

  9. 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.

  10. 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 ...

  11. 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.

  12. 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.

  13. 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...

  14. 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.

  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. 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

  17. 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.

  18. Clinical Trials

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    Full Text Available ... education for parents, clinicians, researchers, children, and the general public. What to Expect During a clinical trial, ... be identified earlier than they would be in general medical practice. This is because late-phase trials ...

  19. 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 ...

  20. 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, ...

  1. 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 ...

  2. Clinical Trials

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    Full Text Available ... Diseases Heart and Vascular Diseases Precision Medicine Activities Obesity, Nutrition, and Physical Activity Population and Epidemiology Studies ... the past, clinical trial participants often were White men. Researchers assumed that trial results were valid for ...

  3. Clinical Trials

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    Full Text Available ... quickly show this information if safety issues arise. Participation and Eligibility Each clinical trial defines who is ... parents, clinicians, researchers, children, and the general public. What to Expect During a clinical trial, doctors, nurses, ...

  4. Clinical Trials

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

  5. 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 ... other for moderate persistent asthma. The results provided important treatment information for doctors and patients. The results ...

  6. 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 ...

  7. Clinical Trials

    Science.gov (United States)

    Clinical trials are research studies that test how well new medical approaches work in people. Each study answers ... prevent, screen for, diagnose, or treat a disease. Clinical trials may also compare a new treatment to a ...

  8. 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 ...

  9. 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, ...

  10. Clinical Trials

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    Full Text Available ... a Clinical Trial If you're interested in learning more about, or taking part in, clinical trials, ... lung, and blood disorders. By engaging the research community and a broad group of stakeholders and advisory ...

  11. Clinical Trials

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    Full Text Available ... Clinical Trials Are Important Clinical trials are a key research tool for advancing medical knowledge and patient ... that does the study uses the same protocol. Key information in a protocol includes how many patients ...

  12. 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

  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. 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

  15. 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

  16. 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.

  17. 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

  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

    2018-02-01

    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. Do Chinese Researchers Conduct Ethical Research and Use Ethics Committee Review in Clinical Trials of Anti-Dementia Drugs? An Analysis of Biomedical Publications Originating from China.

    Science.gov (United States)

    Zeng, Lingfeng; Liang, Weixiong; Pan, Jianke; Cao, Ye; Liu, Jun; Wang, Qi; Wang, Lu; Zou, Yuanping; Wang, Kezhu; Kong, Lingshuo; Xie, Hui; Xu, Weihua; Li, Weirong; Zhao, Wei; Mi, Suiqing; Chen, Yunbo; Cheng, Shuyi; Li, Xiaoyan; Cao, Qian; Zeng, Xing; Wang, Ningsheng

    2016-03-25

    Medical research using human participants must conform to the basic ethical principles found in the Declaration of Helsinki (DoH) of the World Medical Association. The purpose of this review was to assess whether journals in China have improved in regard to the fulfillment of ethical disclosure procedures for clinical trials of anti-dementia drugs. Four medical databases were searched for articles reporting clinical trials of oral anti-dementia drugs published in China in 2003, 2009, and 2014. The frequencies of reporting of informed consent from participants (ICP), approval of a regional ethical committee (REC), reference to DoH, and study registration were estimated respectively. Statistical analyses were conducted with SPSS v21 software. Among those randomized controlled trials published in 2003, 2009, and 2014, disclosure of REC approval was present for 2.67%, 1.15%, and 6.84%; statements of ICP were included in 9.33%, 7.76%, and 17.34%; reference to DoH was found for 4.00%, 1.44%, and 7.45%; and study registration reporting was included in 2.67%, 2.59%, and 9.28%, respectively. Improvements to reporting rates between 2009 and 2014 were seen, with more than twice as many trials reporting REC approval, ICP, reference to DoH, and study registration compared with 2009. Compared with 2003 and 2009, reporting rates for REC approval, ICP, reference to DoH, and study registration for clinical trials of anti-dementia drugs were enhanced in 2014 in the major medical journals of China. However, biomedical publications without definite statements of ethical considerations remain common, and this continues to be seen in Chinese journals. It is imperative that measures are taken to reinforce the ethical protection in clinical trials in China.

  20. 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

  1. 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.

  2. Long-term (5 year) safety of bronchial thermoplasty: Asthma Intervention Research (AIR) trial

    Science.gov (United States)

    2011-01-01

    Background Bronchial thermoplasty (BT) is a bronchoscopic procedure that improves asthma control by reducing excess airway smooth muscle. Treated patients have been followed out to 5 years to evaluate long-term safety of this procedure. Methods Patients enrolled in the Asthma Intervention Research Trial were on inhaled corticosteroids ≥200 μg beclomethasone or equivalent + long-acting-beta2-agonists and demonstrated worsening of asthma on long-acting-β2-agonist withdrawal. Following initial evaluation at 1 year, subjects were invited to participate in a 4 year safety study. Adverse events (AEs) and spirometry data were used to assess long-term safety out to 5 years post-BT. Results 45 of 52 treated and 24 of 49 control group subjects participated in long-term follow-up of 5 years and 3 years respectively. The rate of respiratory adverse events (AEs/subject) was stable in years 2 to 5 following BT (1.2, 1.3, 1.2, and 1.1, respectively,). There was no increase in hospitalizations or emergency room visits for respiratory symptoms in Years 2, 3, 4, and 5 compared to Year 1. The FVC and FEV1 values showed no deterioration over the 5 year period in the BT group. Similar results were obtained for the Control group. Conclusions The absence of clinical complications (based on AE reporting) and the maintenance of stable lung function (no deterioration of FVC and FEV1) over a 5-year period post-BT in this group of patients with moderate to severe asthma support the long-term safety of the procedure out to 5 years. PMID:21314924

  3. Long-term (5 year safety of bronchial thermoplasty: Asthma Intervention Research (AIR trial

    Directory of Open Access Journals (Sweden)

    Pavord Ian D

    2011-02-01

    Full Text Available Abstract Background Bronchial thermoplasty (BT is a bronchoscopic procedure that improves asthma control by reducing excess airway smooth muscle. Treated patients have been followed out to 5 years to evaluate long-term safety of this procedure. Methods Patients enrolled in the Asthma Intervention Research Trial were on inhaled corticosteroids ≥200 μg beclomethasone or equivalent + long-acting-beta2-agonists and demonstrated worsening of asthma on long-acting-β2-agonist withdrawal. Following initial evaluation at 1 year, subjects were invited to participate in a 4 year safety study. Adverse events (AEs and spirometry data were used to assess long-term safety out to 5 years post-BT. Results 45 of 52 treated and 24 of 49 control group subjects participated in long-term follow-up of 5 years and 3 years respectively. The rate of respiratory adverse events (AEs/subject was stable in years 2 to 5 following BT (1.2, 1.3, 1.2, and 1.1, respectively,. There was no increase in hospitalizations or emergency room visits for respiratory symptoms in Years 2, 3, 4, and 5 compared to Year 1. The FVC and FEV1 values showed no deterioration over the 5 year period in the BT group. Similar results were obtained for the Control group. Conclusions The absence of clinical complications (based on AE reporting and the maintenance of stable lung function (no deterioration of FVC and FEV1 over a 5-year period post-BT in this group of patients with moderate to severe asthma support the long-term safety of the procedure out to 5 years.

  4. Improving Breast Cancer Research Through Automated Matching of Patients to Clinical Trials

    National Research Council Canada - National Science Library

    Hall, Lawrence

    2004-01-01

    .... It allows for cost preferences to be entered. Therefore, the system user can choose to rule patients out of trials as quickly as possible without regard to the cost of tests necessary to do this...

  5. Improving Breast Cancer Research Through Automated Matching of Patients to Clinical Trials

    National Research Council Canada - National Science Library

    Hall, Lawrence

    2003-01-01

    .... It allows for cost preferences to be entered. Therefore, the system user can choose to rule patients out of trials as quickly as possible without regard to the cost of tests necessary to do this...

  6. 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...

  7. 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

  8. 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.

  9. Clinical trial design in non-invasive brain stimulation psychiatric research.

    Science.gov (United States)

    Brunoni, André Russowsky; Fregni, Felipe

    2011-06-01

    Major depressive disorder (MDD) trials - investigating either non-pharmacological or pharmacological interventions - have shown mixed results. Many reasons explain this heterogeneity, but one that stands out is the trial design due to specific challenges in the field. We aimed therefore to review the methodology of non-invasive brain stimulation (NIBS) trials and provide a framework to improve clinical trial design. We performed a systematic review for randomized, controlled MDD trials whose intervention was transcranial magnetic stimulation (rTMS) or transcranial direct current stimulation (tDCS) in MEDLINE and other databases from April 2002 to April 2008. We created an unstructured checklist based on CONSORT guidelines to extract items such as power analysis, sham method, blinding assessment, allocation concealment, operational criteria used for MDD, definition of refractory depression and primary study hypotheses. Thirty-one studies were included. We found that the main methodological issues can be divided in to three groups: (1) issues related to phase II/small trials, (2) issues related to MDD trials and, (3) specific issues of NIBS studies. Taken together, they can threaten study validity and lead to inconclusive results. Feasible solutions include: estimating the sample size a priori; measuring the degree of refractoriness of the subjects; specifying the primary hypothesis and statistical tests; controlling predictor variables through stratification randomization methods or using strict eligibility criteria; adjusting the study design to the target population; using adaptive designs and exploring NIBS efficacy employing biological markers. In conclusion, our study summarizes the main methodological issues of NIBS trials and proposes a number of alternatives to manage them. Copyright © 2011 John Wiley & Sons, Ltd.

  10. 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.

  11. Is the large simple trial design used for comparative, post-approval safety research? A review of a clinical trials registry and the published literature.

    Science.gov (United States)

    Reynolds, Robert F; Lem, Joanna A; Gatto, Nicolle M; Eng, Sybil M

    2011-10-01

    Post-approval, observational drug safety studies face well known difficulties in controlling for confounding, particularly confounding by indication for drug use. A study design that addresses confounding by indication is the large simple trial (LST). LSTs are characterized by large sample sizes, often in the thousands; broad entry criteria consistent with the approved medication label; randomization based on equipoise, i.e. neither physician nor patient believes that one treatment option is superior; minimal, streamlined data collection requirements; objectively-measured endpoints (e.g. death, hospitalization); and follow-up that minimizes interventions or interference with normal clinical practice. In theory then, the LST is a preferred study design for drug and vaccine safety research because it controls for biases inherent to observational research while still providing results that are generalizable to 'real-world' use. To evaluate whether LSTs are used for comparative safety evaluation and if the design is, in fact, advantageous compared with other designs, we conducted a review of the published literature (1949 through 31 December 2010) and the ClinicalTrials.gov registry (2000 through 31 December 2010). Thirteen ongoing or completed safety LSTs were identified. The design has rarely been used in comparative drug safety research, which is due to the operational, financial and scientific hurdles of implementing the design. The studies that have been completed addressed important clinical questions and, in some cases, led to re-evaluation of medical practice. We conclude the design has demonstrated utility for comparative safety research of medicines and vaccines if the necessary scientific and operational conditions for its use are met.

  12. 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

  13. 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.

  14. Modern clinical research: How rapid learning health care and cohort multiple randomised clinical trials complement traditional evidence based medicine.

    Science.gov (United States)

    Lambin, Philippe; Zindler, Jaap; Vanneste, Ben; van de Voorde, Lien; Jacobs, Maria; Eekers, Daniëlle; Peerlings, Jurgen; Reymen, Bart; Larue, Ruben T H M; Deist, Timo M; de Jong, Evelyn E C; Even, Aniek J G; Berlanga, Adriana J; Roelofs, Erik; Cheng, Qing; Carvalho, Sara; Leijenaar, Ralph T H; Zegers, Catharina M L; van Limbergen, Evert; Berbee, Maaike; van Elmpt, Wouter; Oberije, Cary; Houben, Ruud; Dekker, Andre; Boersma, Liesbeth; Verhaegen, Frank; Bosmans, Geert; Hoebers, Frank; Smits, Kim; Walsh, Sean

    2015-01-01

    Trials are vital in informing routine clinical care; however, current designs have major deficiencies. An overview of the various challenges that face modern clinical research and the methods that can be exploited to solve these challenges, in the context of personalised cancer treatment in the 21st century is provided. The purpose of this manuscript, without intending to be comprehensive, is to spark thought whilst presenting and discussing two important and complementary alternatives to traditional evidence-based medicine, specifically rapid learning health care and cohort multiple randomised controlled trial design. Rapid learning health care is an approach that proposes to extract and apply knowledge from routine clinical care data rather than exclusively depending on clinical trial evidence, (please watch the animation: http://youtu.be/ZDJFOxpwqEA). The cohort multiple randomised controlled trial design is a pragmatic method which has been proposed to help overcome the weaknesses of conventional randomised trials, taking advantage of the standardised follow-up approaches more and more used in routine patient care. This approach is particularly useful when the new intervention is a priori attractive for the patient (i.e. proton therapy, patient decision aids or expensive medications), when the outcomes are easily collected, and when there is no need of a placebo arm. Truly personalised cancer treatment is the goal in modern radiotherapy. However, personalised cancer treatment is also an immense challenge. The vast variety of both cancer patients and treatment options makes it extremely difficult to determine which decisions are optimal for the individual patient. Nevertheless, rapid learning health care and cohort multiple randomised controlled trial design are two approaches (among others) that can help meet this challenge.

  15. Guidance for the verification and validation of neural networks

    CERN Document Server

    Pullum, L; Darrah, M

    2007-01-01

    Guidance for the Verification and Validation of Neural Networks is a supplement to the IEEE Standard for Software Verification and Validation, IEEE Std 1012-1998. Born out of a need by the National Aeronautics and Space Administration's safety- and mission-critical research, this book compiles over five years of applied research and development efforts. It is intended to assist the performance of verification and validation (V&V) activities on adaptive software systems, with emphasis given to neural network systems. The book discusses some of the difficulties with trying to assure adaptive systems in general, presents techniques and advice for the V&V practitioner confronted with such a task, and based on a neural network case study, identifies specific tasking and recommendations for the V&V of neural network systems.

  16. 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.

  17. 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.

  18. Integrating collection of biospecimens in clinical trials: the approach of the European organization for research and treatment of cancer.

    Science.gov (United States)

    Hall, Jacqueline A; Daidone, Maria Grazia; Peters, Godefridus J; Harbeck, Nadia; Lacombe, Denis; Sleijfer, Stefan

    2011-06-01

    Access to biospecimens and their derivatives, that is, human biological materials (HBM), for translational research (TR) is considered a major bottleneck hindering successful bench to bedside translation. Clinical trials offer a unique opportunity to collect HBM in a specialized setting that allows prospectively designed, high-quality TR that would be difficult to fulfill from community- or population-based HBM collections alone. Increasingly, as the field advances toward personalized treatment of cancer patients, access to HBM is becoming a necessity for patient enrollment in a new generation of clinical studies that are designed and driven by molecular hypotheses. The European Organization for Research and Treatment of Cancer (EORTC) is one of the largest networks for clinical trials in oncology. The EORTC is re-focusing its strategy, building on experiences and expertise gained over the years from specific initiatives such as EORTC Group activities and the EORTC Virtual Tumour Bank, by developing new mechanisms to support investigators with the practical aspects of HBM collection as part of EORTC clinical studies. Due to the complex, multidisciplinary nature of HBM collection and TR, integration of HBM collection into clinical trials warrants careful upfront planning and input from a range of expertise. To simplify HBM collection in clinical studies, the EORTC has developed a simple checklist containing the key elements of HBM collection setup and combines these into a simple tool for practical use. Through identifying and managing key risk areas, this can maximize the HBM collection success while achieving efficient clinical trial development. This article focuses on the key elements of HBM collection and the approaches of the EORTC for efficiently integrating this collection into clinical trial development.

  19. Assessing the challenges of multi-scope clinical research sites: an example from NIH HIV/AIDS clinical trials networks.

    Science.gov (United States)

    Rosas, Scott R; Cope, Marie T; Villa, Christie; Motevalli, Mahnaz; Utech, Jill; Schouten, Jeffrey T

    2014-04-01

    Large-scale, multi-network clinical trials are seen as a means for efficient and effective utilization of resources with greater responsiveness to new discoveries. Formal structures instituted within the National Institutes of Health (NIH) HIV/AIDS Clinical Trials facilitate collaboration and coordination across networks and emphasize an integrated approach to HIV/AIDS vaccine, prevention and therapeutics clinical trials. This study examines the joint usage of clinical research sites as means of gaining efficiency, extending capacity, and adding scientific value to the networks. A semi-structured questionnaire covering eight clinical management domains was administered to 74 (62% of sites) clinical site coordinators at single- and multi-network sites to identify challenges and efficiencies related to clinical trials management activities and coordination with multi-network units. Overall, respondents at multi-network sites did not report more challenges than single-network sites, but did report unique challenges to overcome including in the areas of study prioritization, community engagement, staff education and training, and policies and procedures. The majority of multi-network sites reported that such affiliations do allow for the consolidation and cost-sharing of research functions. Suggestions for increasing the efficiency or performance of multi-network sites included streamlining standards and requirements, consolidating protocol activation methods, using a single cross-network coordinating centre, and creating common budget and payment mechanisms. The results of this assessment provide important information to consider in the design and management of multi-network configurations for the NIH HIV/AIDS Clinical Trials Networks, as well as others contemplating and promoting the concept of multi-network settings. © 2013 John Wiley & Sons Ltd.

  20. 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.

  1. 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

  2. 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)

  3. Event detection using population-based health care databases in randomized clinical trials: a novel research tool in interventional cardiology

    Directory of Open Access Journals (Sweden)

    Thuesen L

    2013-09-01

    Full Text Available Leif Thuesen,1 Lisette Okkels Jensen,2 Hans Henrik Tilsted,3 Michael Mæng,1 Christian Terkelsen,1 Per Thayssen,2 Jan Ravkilde,3 Evald Høj Christiansen,1 Hans Erik Bøtker,1 Morten Madsen,4 Jens F Lassen1 1Department of Cardiology, Aarhus University Hospital, Skejby, Denmark; 2Department of Cardiology, Odense University Hospital, Odense, Denmark; 3Department of Cardiology, Aalborg University Hospital, Aalborg, Denmark; 4Department of Clinical Epidemiology, Aarhus University Hospital, Skejby, Denmark Aim: To describe a new research tool, designed to reflect routine clinical practice and relying on population-based health care databases to detect clinical events in randomized clinical trials. Background: Randomized clinical trials often focus on short-term efficacy and safety in a controlled environment. Trial follow-up may be linked with study-related investigations and differ from routine clinical practice. Because treatment and control in randomized trials differ from daily practice, trial results may have reduced general applicability and may be of limited value in clinical decision-making. Further, it is economically very costly to conduct randomized clinical trials. Methods and results: Population-based health care databases collect data continuously and prospectively, and make it possible to monitor lifelong outcomes of cardiac interventions in large numbers of patients. This strengthens external validity by eliminating the effects of study-related monitoring or diagnostic tests. Further, follow-up data can be obtained at low expense. Importantly, data sources encompassing a complete population are likely to reflect clinical practice. Because population-based health care databases collect data for quality-control and administrative purposes unrelated to scientific investigations, certain biases, such as nonresponse bias, recall bias, and bias from losses to follow-up, can be avoided. Conclusion: Event detection using population

  4. 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. 

  5. Clinical Trials

    Medline Plus

    Full Text Available ... trial participants. Children and Clinical Studies Learn about the importance of children in clinical studies and get answers to common questions. NIH Clinical Research Trials and You Get additional guidance on participating in clinical trials at the NIH. The NHLBI conducts a large number of ...

  6. Transporting Clinical Research to Community Settings: Designing and Conducting a Multisite Trial of Brief Strategic Family Therapy

    Science.gov (United States)

    Robbins, Michael S.; Alonso, Elizabeth; Horigian, Viviana E.; Bachrach, Ken; Burlew, Kathy; Carrión, Ibis S.; Hodgkins, Candace C.; Miller, Michael; Schindler, Eric; VanDeMark, Nancy; Henderson, Craig; Szapocznik, José

    2010-01-01

    This paper describes the development and implementation of a trial of Brief Strategic Family Therapy (BSFT), an evidence-based drug intervention for adolescents, in eight community substance abuse treatment programs. Researchers and treatment programs collaborated closely to identify and overcome challenges, many of them related to achieving results that were both scientifically rigorous and applicable to the widest possible variety of adolescent substance abuse treatment programs. To meet these challenges, the collaborative team drew on lessons and practices from efficacy, effectiveness, and implementation research. PMID:22002455

  7. 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.

  8. Clinical trial tests drug for tumors associated with Krebs-cycle dysfunction | Center for Cancer Research

    Science.gov (United States)

    The Krebs cycle is part of the complex process where cells turn food into energy. One of the elements of the Krebs cycle is succinate dehydrogenase (SDH). Loss of SDH activity in cells has been linked to tumor formation. This new trial is studying guadecitabine for tumors associated with Krebs cycle dysfunction. Learn more...

  9. 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.

  10. 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)

  11. 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

  12. 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

  13. 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.

  14. VERIFICATION OF PARALLEL AUTOMATA-BASED PROGRAMS

    OpenAIRE

    M. A. Lukin

    2014-01-01

    The paper deals with an interactive method of automatic verification for parallel automata-based programs. The hierarchical state machines can be implemented in different threads and can interact with each other. Verification is done by means of Spin tool and includes automatic Promela model construction, conversion of LTL-formula to Spin format and counterexamples in terms of automata. Interactive verification gives the possibility to decrease verification time and increase the maxi...

  15. ASC Predictive Science Academic Alliance Program Verification and Validation Whitepaper

    Energy Technology Data Exchange (ETDEWEB)

    Klein, R; Graziani, F; Trucano, T

    2006-03-31

    The purpose of this whitepaper is to provide a framework for understanding the role that verification and validation (V&V) are expected to play in successful ASC Predictive Science Academic Alliance (PSAA) Centers and projects. V&V have been emphasized in the recent specification of the PSAA (NNSA, 2006): (1) The resulting simulation models lend themselves to practical verification and validation methodologies and strategies that should include the integrated use of experimental and/or observational data as a key part of model and sub-model validation, as well as demonstrations of numerical convergence and accuracy for code verification. (2) Verification, validation and prediction methodologies and results must be much more strongly emphasized as research topics and demonstrated via the proposed simulations. (3) It is mandatory that proposals address the following two topics: (a) Predictability in science & engineering; and (b) Verification & validation strategies for large-scale simulations, including quantification of uncertainty and numerical convergence. We especially call attention to the explicit coupling of computational predictability and V&V in the third bullet above. In this whitepaper we emphasize this coupling, and provide concentrated guidance for addressing item 2. The whitepaper has two main components. First, we provide a brief and high-level tutorial on V&V that emphasizes critical elements of the program. Second, we state a set of V&V-related requirements that successful PSAA proposals must address.

  16. 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)

  17. 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.

  18. 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)

  19. Formal Verification of Circuits and Systems

    Indian Academy of Sciences (India)

    R. Narasimhan (Krishtel eMaging) 1461 1996 Oct 15 13:05:22

    Today formal verification is finding increasing acceptance in some areas, especially model abstraction and functional verification. Other major chal- lenges, like timing verification, remain before this technology can be posed as a complete alternative to simulation. This special issue is devoted to presenting some of the ...

  20. How well do randomized trials inform decision making: systematic review using comparative effectiveness research measures on acupuncture for back pain.

    Science.gov (United States)

    Witt, Claudia M; Manheimer, Eric; Hammerschlag, Richard; Lüdtke, Rainer; Lao, Lixing; Tunis, Sean R; Berman, Brian M

    2012-01-01

    For Comparative Effectiveness Research (CER) there is a need to develop scales for appraisal of available clinical research. Aims were to 1) test the feasibility of applying the pragmatic-explanatory continuum indicator summary tool and the six CER defining characteristics of the Institute of Medicine to RCTs of acupuncture for treatment of low back pain, and 2) evaluate the extent to which the evidence from these RCTs is relevant to clinical and health policy decision making. We searched Medline, the AcuTrials™ Database to February 2011 and reference lists and included full-report randomized trials in English that compared needle acupuncture with a conventional treatment in adults with non-specific acute and/or chronic low back pain and restricted to those with ≥30 patients in the acupuncture group. Papers were evaluated by 5 raters. From 119 abstracts, 44 full-text publications were screened and 10 trials (4,901 patients) were evaluated. Due to missing information and initial difficulties in operationalizing the scoring items, the first scoring revealed inter-rater and inter-item variance (intraclass correlations 0.02-0.60), which improved after consensus discussions to 0.20-1.00. The 10 trials were found to cover the efficacy-effectiveness continuum; those with more flexible acupuncture and no placebo control scored closer to effectiveness. Both instruments proved useful, but need further development. In addition, CONSORT guidelines for reporting pragmatic trials should be expanded. Most studies in this review already reflect the movement towards CER and similar approaches can be taken to evaluate comparative effectiveness relevance of RCTs for other treatments.

  1. How well do randomized trials inform decision making: systematic review using comparative effectiveness research measures on acupuncture for back pain.

    Directory of Open Access Journals (Sweden)

    Claudia M Witt

    Full Text Available For Comparative Effectiveness Research (CER there is a need to develop scales for appraisal of available clinical research. Aims were to 1 test the feasibility of applying the pragmatic-explanatory continuum indicator summary tool and the six CER defining characteristics of the Institute of Medicine to RCTs of acupuncture for treatment of low back pain, and 2 evaluate the extent to which the evidence from these RCTs is relevant to clinical and health policy decision making.We searched Medline, the AcuTrials™ Database to February 2011 and reference lists and included full-report randomized trials in English that compared needle acupuncture with a conventional treatment in adults with non-specific acute and/or chronic low back pain and restricted to those with ≥30 patients in the acupuncture group. Papers were evaluated by 5 raters.From 119 abstracts, 44 full-text publications were screened and 10 trials (4,901 patients were evaluated. Due to missing information and initial difficulties in operationalizing the scoring items, the first scoring revealed inter-rater and inter-item variance (intraclass correlations 0.02-0.60, which improved after consensus discussions to 0.20-1.00. The 10 trials were found to cover the efficacy-effectiveness continuum; those with more flexible acupuncture and no placebo control scored closer to effectiveness.Both instruments proved useful, but need further development. In addition, CONSORT guidelines for reporting pragmatic trials should be expanded. Most studies in this review already reflect the movement towards CER and similar approaches can be taken to evaluate comparative effectiveness relevance of RCTs for other treatments.

  2. 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.

  3. Placeboxetine for major depressive disorder: Researcher, author, reader, and reviewer perspectives on randomized controlled trials

    OpenAIRE

    Andrade, Chittaranjan

    2011-01-01

    Background: Postgraduate students, budding authors, clinicians who read journals, and new reviewers need to develop skills in reading, writing, and reviewing papers that describe randomized controlled trials (RCTs). Materials and Methods: This commentary critically examines a specially-written paper (published in the same issue of this journal) that describes a fictitious, industry-driven, multicentre RCT comparing the fictitious antidepressant placeboxetine with sertraline in Indian patients...

  4. 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

  5. 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

  6. Runtime Verification in Distributed Computing

    NARCIS (Netherlands)

    Malakuti Khah Olun Abadi, Somayeh; Park, Jong Hyuk; Obaidat, Mohammad; Aksit, Mehmet; Bockisch, Christoph

    2011-01-01

    Runtime verification aims to check whether an application executes its behaviour as specified. Thereby the active execution trace of an application is checked in terms of the actual execution context; diagnosis and, possibly, recovery actions are taken when the specification is violated. In today’s

  7. 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...

  8. Verification and validation for CIPRNet

    NARCIS (Netherlands)

    Voogd, J.

    2016-01-01

    In this chapter it is shown that if an appreciable risk is present in the use of Modelling and Simulation (M&S), Verification and Validation (V&V) should be employed to manage and mitigate that risk. The use of M&S in the domain of critical infrastructure (CI) will always be accompanied by such a

  9. 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

  10. 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

    Background 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. Methods And Findings 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. Conclusions 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

  11. 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

  12. Inconsistencies in quality of life data collection in clinical trials: a potential source of bias? Interviews with research nurses and trialists.

    Directory of Open Access Journals (Sweden)

    Derek Kyte

    Full Text Available 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

  13. Do health care institutions value research? A mixed methods study of barriers and facilitators to methodological rigor in pediatric randomized trials.

    Science.gov (United States)

    Hamm, Michele P; Scott, Shannon D; Klassen, Terry P; Moher, David; Hartling, Lisa

    2012-10-18

    Pediatric randomized controlled trials (RCTs) are susceptible to a high risk of bias. We examined the barriers and facilitators that pediatric trialists face in the design and conduct of unbiased trials. We used a mixed methods design, with semi-structured interviews building upon the results of a quantitative survey. We surveyed Canadian (n=253) and international (n=600) pediatric trialists regarding their knowledge and awareness of bias and their perceived barriers and facilitators in conducting clinical trials. We then interviewed 13 participants from different subspecialties and geographic locations to gain a more detailed description of how their experiences and attitudes towards research interacted with trial design and conduct. The survey response rate was 23.0% (186/807). 68.1% of respondents agreed that bias is a problem in pediatric RCTs and 72.0% felt that there is sufficient evidence to support changing some aspects of how trials are conducted. Knowledge related to bias was variable, with inconsistent awareness of study design features that may introduce bias into a study. Interview participants highlighted a lack of formal training in research methods, a negative research culture, and the pragmatics of trial conduct as barriers. Facilitators included contact with knowledgeable and supportive colleagues and infrastructure for research. A lack of awareness of bias and negative attitudes towards research present significant barriers in terms of conducting methodologically rigorous pediatric RCTs. Knowledge translation efforts must focus on these issues to ensure the relevance and validity of trial results.

  14. Authoring and verification of clinical guidelines: a model driven approach.

    Science.gov (United States)

    Pérez, Beatriz; Porres, Ivan

    2010-08-01

    The goal of this research is to provide a framework to enable authoring and verification of clinical guidelines. The framework is part of a larger research project aimed at improving the representation, quality and application of clinical guidelines in daily clinical practice. The verification process of a guideline is based on (1) model checking techniques to verify guidelines against semantic errors and inconsistencies in their definition, (2) combined with Model Driven Development (MDD) techniques, which enable us to automatically process manually created guideline specifications and temporal-logic statements to be checked and verified regarding these specifications, making the verification process faster and cost-effective. Particularly, we use UML statecharts to represent the dynamics of guidelines and, based on this manually defined guideline specifications, we use a MDD-based tool chain to automatically process them to generate the input model of a model checker. The model checker takes the resulted model together with the specific guideline requirements, and verifies whether the guideline fulfils such properties. The overall framework has been implemented as an Eclipse plug-in named GBDSSGenerator which, particularly, starting from the UML statechart representing a guideline, allows the verification of the guideline against specific requirements. Additionally, we have established a pattern-based approach for defining commonly occurring types of requirements in guidelines. We have successfully validated our overall approach by verifying properties in different clinical guidelines resulting in the detection of some inconsistencies in their definition. The proposed framework allows (1) the authoring and (2) the verification of clinical guidelines against specific requirements defined based on a set of property specification patterns, enabling non-experts to easily write formal specifications and thus easing the verification process. Copyright 2010 Elsevier Inc

  15. 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

  16. Measurement of the translation and impact from a childhood obesity trial programme: rationale and protocol for a research impact assessment.

    Science.gov (United States)

    Reeves, Penny; Deeming, Simon; Ramanathan, Shanthi; Wiggers, John; Wolfenden, Luke; Searles, Andrew

    2017-12-19

    There is growing recognition amongst health and medical research funders and researchers that translation of research into policy and practice needs to increase and that more transparency is needed on how impacts are realised. Several approaches are advocated for achieving this, including co-production of research or academic-practitioner research. The Population Health Unit (PHU) within the Hunter New England Local Health District in regional Australia, as an early adopter of this model, has been working to increase the likelihood that its research is translated into community health benefits. With the New South Wales Ministry of Health, the PHU responded to the burden of child overweight and obesity by combining service delivery with research expertise. The 'Good for Kids, Good for Life' (Good for Kids) dissemination trial was developed and implemented in seven community settings in the Hunter region of Australia between 2006 and 2010. This study aims to undertake a retrospective impact assessment to measure the research translation and impact of Good for Kids. The method will be based upon the application of the Framework to Assess the Impact from Translational health research (FAIT), comprising three core elements, namely quantified metrics, economic assessment and a narrative of the process by which the research in question translates and generates impact. Increasingly, funders are interested both in the outcomes resulting from investments in health research and in the expected return on their investments. FAIT was developed specifically for this purpose and its use is anticipated to provide transparency to the pathway to translation and potentially drive increased investment in translational research programmes such as Good for Kids.

  17. 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.

  18. 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.

  19. 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.

  20. 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

  1. 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.

  2. Trials, Tribulations, and Occasional Jubilations while Conducting Research with Homeless Children, Youth, and Families

    Science.gov (United States)

    Toro, Paul A.

    2006-01-01

    A personal account of a program of research on homelessness and poverty spanning the past 20 years is provided, with a focus on the many methodological, practical, and ethical difficulties encountered. Interesting discoveries and enjoyable aspects of the research process are also presented. Several role conflicts that arose for the researcher in…

  3. Clinical Trials

    Medline Plus

    Full Text Available ... long and careful research process. The process often begins in a laboratory (lab), where scientists first develop ... IRB reviews the trial's protocol before the study begins. An IRB will only approve research that deals ...

  4. Clinical Trials

    Medline Plus

    Full Text Available ... trials are research studies that explore whether a medical strategy, treatment, or device is safe and effective ... IRBs, develop educational programs and materials, and offer advice on research-related issues. Data Safety Monitoring Board ...

  5. 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.

  6. 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...

  7. 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/

  8. The TrialsTracker: Automated ongoing monitoring of failure to share clinical trial results by all major companies and research institutions

    OpenAIRE

    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 summ...

  9. 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

  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

    2018-04-01

    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.

  11. 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

  12. 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

  13. 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.

  14. 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...

  15. Formal Verification of Continuous Systems

    DEFF Research Database (Denmark)

    Sloth, Christoffer

    2012-01-01

    The purpose of this thesis is to develop a method for verifying timed temporal properties of continuous dynamical systems, and to develop a method for verifying the safety of an interconnection of continuous systems. The methods must be scalable in the number of continuous variables...... to the high complexity of both the dynamical system and the specification. Therefore, there is a need for methods capable of verifying complex specifications of complex systems. The verification of high dimensional continuous dynamical systems is the key to verifying general systems. In this thesis......, an abstraction approach is taken to the verification problem. A method is developed for abstracting continuous dynamical systems by timed automata. This method is based on subdividing the state space into cells by use of subdivisioning functions that are decreasing along the vector field. To allow...

  16. 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

  17. 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

  18. 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)

  19. 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.

  20. 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.)

  1. 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

  2. MUSE WFM AO Science Verification

    Science.gov (United States)

    Leibundgut, B.; Bacon, R.; Jaffé, Y. L.; Johnston, E.; Kuntschner, H.; Selman, F.; Valenti, E.; Vernet, J.; Vogt, F.

    2017-12-01

    The goal of Science Verification (SV) as part of the transition into operations is to carry out scientific observations to test the end-to-end operations of a new instrument or new instrument modes. The Multi Unit Spectroscopic Explorer, (MUSE; Bacon et al., 2010), at the Very Large Telescope (VLT) can be operated in several modes. The wide-field mode has been offered since Period 94 (October 2014) for natural-seeing observations. With the commissioning of the Adaptive Optics Facility (AOF; Arsenault et al., 2017) the wide-field mode can be supported by ground-layer adaptive optics through four artificial laser guide stars and the adaptive optics module, Ground Atmospheric Layer Adaptive OptiCs for Spectroscopic Imaging (GALACSI). The MUSE wide-field mode adaptive optics Science Verification (hereafter referred to MUSE WFM AO SV) was scheduled from 12–14 August 2017. Out of 41 submitted proposals, 19 observing programmes were scheduled, covering a wide range of science topics and amounting to an allocation of 42 hours. This included sufficient oversubscription to cover all expected observing conditions. Due to inclement weather during the original SV nights, two more nights were allocated on 16 and 17 September 2017 to observe more programmes. In total, seven programmes were completed, six programmes received partial data, and the remaining six projects could not be started. We summarise here the planning, execution and first results from the Science Verification.

  3. 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.

  4. 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

  5. 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.

  6. 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

  7. Variability in research ethics review of cluster randomized trials: a scenario-based survey in three countries.

    Science.gov (United States)

    Taljaard, Monica; Brehaut, Jamie C; Weijer, Charles; Boruch, Robert; Donner, Allan; Eccles, Martin P; McRae, Andrew D; Saginur, Raphael; Zwarenstein, Merrick; Grimshaw, Jeremy M

    2014-02-05

    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. 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. 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. Research ethics committees identified a clear need for ethics guidelines for

  8. 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.

  9. Consortium for Verification Technology Fellowship Report.

    Energy Technology Data Exchange (ETDEWEB)

    Sadler, Lorraine E. [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States)

    2017-06-01

    As one recipient of the Consortium for Verification Technology (CVT) Fellowship, I spent eight days as a visiting scientist at the University of Michigan, Department of Nuclear Engineering and Radiological Sciences (NERS). During this time, I participated in multiple department and research group meetings and presentations, met with individual faculty and students, toured multiple laboratories, and taught one-half of a one-unit class on Risk Analysis in Nuclear Arms control (six 1.5 hour lectures). The following report describes some of the interactions that I had during my time as well as a brief discussion of the impact of this fellowship on members of the consortium and on me/my laboratory’s technical knowledge and network.

  10. Accuracy verification methods theory and algorithms

    CERN Document Server

    Mali, Olli; Repin, Sergey

    2014-01-01

    The importance of accuracy verification methods was understood at the very beginning of the development of numerical analysis. Recent decades have seen a rapid growth of results related to adaptive numerical methods and a posteriori estimates. However, in this important area there often exists a noticeable gap between mathematicians creating the theory and researchers developing applied algorithms that could be used in engineering and scientific computations for guaranteed and efficient error control.   The goals of the book are to (1) give a transparent explanation of the underlying mathematical theory in a style accessible not only to advanced numerical analysts but also to engineers and students; (2) present detailed step-by-step algorithms that follow from a theory; (3) discuss their advantages and drawbacks, areas of applicability, give recommendations and examples.

  11. Shortcomings of protocols of drug trials in relation to sponsorship as identified by Research Ethics Committees: analysis of comments raised during ethical review.

    Science.gov (United States)

    van Lent, Marlies; Rongen, Gerard A; Out, Henk J

    2014-12-10

    Submission of study protocols to research ethics committees (RECs) constitutes one of the earliest stages at which planned trials are documented in detail. Previous studies have investigated the amendments requested from researchers by RECs, but the type of issues raised during REC review have not been compared by sponsor type. The objective of this study was to identify recurring shortcomings in protocols of drug trials based on REC comments and to assess whether these were more common among industry-sponsored or non-industry trials. Retrospective analysis of 226 protocols of drug trials approved in 2010-2011 by three RECs affiliated to academic medical centres in The Netherlands. For each protocol, information on sponsorship, number of participating centres, participating countries, study phase, registration status of the study drug, and type and number of subjects was retrieved. REC comments were extracted from decision letters sent to investigators after review and were classified using a predefined checklist that was based on legislation and guidelines on clinical drug research and previous literature. Most protocols received comments regarding participant information and consent forms (n = 182, 80.5%), methodology and statistical analyses (n = 160, 70.8%), and supporting documentation, including trial agreements and certificates of insurance (n = 154, 68.1%). Of the submitted protocols, 122 (54.0%) were non-industry and 104 (46.0%) were industry-sponsored trials. Non-industry trials more often received comments on subject selection (n = 44, 36.1%) than industry-sponsored trials (n = 18, 17.3%; RR, 1.58; 95% CI, 1.01 to 2.47), and on methodology and statistical analyses (n = 95, 77.9% versus n = 65, 62.5%, respectively; RR, 1.18; 95% CI, 1.01 to 1.37). Non-industry trials less often received comments on supporting documentation (n = 72, 59.0%) than industry-sponsored trials (n = 82, 78.8%; RR, 0.83; 95% CI, 0.72 to 0.95). RECs identified important ethical and

  12. 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

  13. Achievement report for fiscal 1996 on the research and development of superconductor technology to power generation. Pt. 1. Research and development of superconducting wire, generator, total system, and refrigeration system; and verification test; 1996 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

    1997-12-01

    In the research and development of superconducting wires, studies are conducted to increase the current capacity of NbTi and Nb{sub 3}Sn metal wires and to improve their properties, and to increase the current capacity of oxide materials and improve their performance making full use of the features of each manufacturing method. In the development of superconducting generators, a slow excitation response type is tested for verification, and a good result is attained; and a quick excitation response type is tested for field winding static excitation, and good performance is exhibited. Using the results so far achieved, the 200,000kW class pilot machine concept design is reviewed. In the study of total systems, feasibility is studied of a quench test for the 70,000kW class machine through simulation analyses, etc. In the development of refrigeration systems, efforts are exerted to improve on the conventional type in terms of reliability and to further improve on the improved version in terms of performance and space-saving feature. One of the endeavors involves the development of a He Brayton cycle turbine driven compressor. A multilayer cylindrical rotor is verified in terms of functions, characteristics, reliability and durability, and various data are collected toward the development of a pilot machine. (NEDO)

  14. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology

    NARCIS (Netherlands)

    Aaronson, N. K.; Ahmedzai, S.; Bergman, B.; Bullinger, M.; Cull, A.; Duez, N. J.; Filiberti, A.; Flechtner, H.; Fleishman, S. B.; de Haes, J. C.; Kaasa, S.; Klee, Marianne; Osoba, David; Razavi, Darius; Rofe, Peter B.; Schraub, S.; Sneeuw, Kommer; Sullivan, Marianne; Takeda, Fumikazu

    1993-01-01

    BACKGROUND: In 1986, the European Organization for Research and Treatment of Cancer (EORTC) initiated a research program to develop an integrated, modular approach for evaluating the quality of life of patients participating in international clinical trials. PURPOSE: We report here the results of an

  15. Shortcomings of protocols of drug trials in relation to sponsorship as identified by Research Ethics Committees: analysis of comments raised during ethical review

    NARCIS (Netherlands)

    Lent, M.J. van; Rongen, G.A.; Out, H.J.

    2014-01-01

    BACKGROUND: Submission of study protocols to research ethics committees (RECs) constitutes one of the earliest stages at which planned trials are documented in detail. Previous studies have investigated the amendments requested from researchers by RECs, but the type of issues raised during REC

  16. Mathematical verification of a nuclear power plant protection system function with combined CPN and PVS

    Energy Technology Data Exchange (ETDEWEB)

    Koo, Seo Ryong; Son, Han Seong; Seong, Poong Hyun [Korea Advanced Institute of Science and Technology, Taejon (Korea, Republic of)

    1998-12-31

    In this work, an automatic software verification method for Nuclear Power Plant (NPP) protection system is developed. This method utilizes Colored Petri Net (CPN) for modeling and Prototype Verification System (PVS) for mathematical verification. In order to help flow-through from modeling by CPN to mathematical proof by PVS, a translator has been developed in this work. The combined method has been applied to a protection system function of Wolsong NPP SDS2(Steam Generator Low Level Trip) and found to be promising for further research and applications. 7 refs., 10 figs. (Author)

  17. 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

  18. Current research and clinical trials for a vaccine against Chikungunya virus

    Directory of Open Access Journals (Sweden)

    Singh P

    2013-08-01

    Full Text Available Priyanka Singh,1 Mala Chhabra,1 Veena Mittal,1 Pankaj Sharma,1 Moshahid A Rizvi,2 Lakhvir Singh Chauhan,1 Arvind Rai1 1National Centre for Disease Control, Sham Nath Marg, 2Department of Biosciences, Jamia Millia Islamia, New Delhi, India Abstract: Chikungunya infection is a self-limiting Aedes mosquito-borne arboviral disease with variable clinical manifestations, ranging from asymptomatic illness to a very severe and crippling arthralgia. Until recently, Chikungunya was a little known disease that re-emerged in 2005–2006, leading to major outbreaks on the Indian Ocean Islands and in South East Asia, and eventually extending its range to temperate regions. It drew global attention due to its explosive onset, extensive geographic distribution, and high morbidity. Since re-emergence, an estimated one million symptomatic cases with 0.1% fatality per year have been reported globally. A lack of herd immunity, vector control, and globalization and trade are clearly a problem in the spread of this disease. The Chikungunya virus (CHIKV has also acquired biologically important mutations during its evolution, increasing its geographic reach. This disease has resulted in a loss of productivity in affected communities. The absence of a vaccine or an effective antiviral therapy makes dealing with this disease challenging for those involved in public health. There is an emergent need for an effective vaccine against CHIKV infection. The candidates that have been tested include attenuated living, nonliving and genetically engineered vaccines. Several of these vaccine candidates are in preclinical and clinical trials. This review outlines the current knowledge about chikungunya infection and vaccine development. Keywords: Chikungunya, outbreaks, epidemics, genotypes, vaccines, therapy

  19. An Efficacy Trial of Research-Based Curriculum Materials with Curriculum-Based Professional Development

    Science.gov (United States)

    Taylor, Joseph A.; Getty, Stephen R.; Kowalski, Susan M.; Wilson, Christopher D.; Carlson, Janet; Van Scotter, Pamela

    2015-01-01

    This study examined the efficacy of a curriculum-based intervention for high school science students. Specifically, the intervention was two years of research-based, multidisciplinary curriculum materials for science supported by comprehensive professional development for teachers that focused on those materials. A modest positive effect was…

  20. Field verification for the effectiveness of continuity diaphragms for skewed continuous P/C P/S concrete girder bridges.

    Science.gov (United States)

    2009-10-01

    The research presented herein describes the field verification for the effectiveness of continuity diaphragms for : skewed continuous precast, prestressed, concrete girder bridges. The objectives of this research are (1) to perform : field load testi...

  1. Verification of chemistry reference ranges using a simple method in sub-Saharan Africa.

    Science.gov (United States)

    De Baetselier, Irith; Taylor, Douglas; Mandala, Justin; Nanda, Kavita; Van Campenhout, Christel; Agingu, Walter; Madurai, Lorna; Barsch, Eva-Maria; Deese, Jennifer; Van Damme, Lut; Crucitti, Tania

    2016-01-01

    Chemistry safety assessments are interpreted by using chemistry reference ranges (CRRs). Verification of CRRs is time consuming and often requires a statistical background. We report on an easy and cost-saving method to verify CRRs. Using a former method introduced by Sigma Diagnostics, three study sites in sub-Saharan Africa, Bondo, Kenya, and Pretoria and Bloemfontein, South Africa, verified the CRRs for hepatic and renal biochemistry assays performed during a clinical trial of HIV antiretroviral pre-exposure prophylaxis. The aspartate aminotransferase/alanine aminotransferase, creatinine and phosphorus results from 10 clinically-healthy participants at the screening visit were used. In the event the CRRs did not pass the verification, new CRRs had to be calculated based on 40 clinically-healthy participants. Within a few weeks, the study sites accomplished verification of the CRRs without additional costs. The aspartate aminotransferase reference ranges for the Bondo, Kenya site and the alanine aminotransferase reference ranges for the Pretoria, South Africa site required adjustment. The phosphorus CRR passed verification and the creatinine CRR required adjustment at every site. The newly-established CRR intervals were narrower than the CRRs used previously at these study sites due to decreases in the upper limits of the reference ranges. As a result, more toxicities were detected. To ensure the safety of clinical trial participants, verification of CRRs should be standard practice in clinical trials conducted in settings where the CRR has not been validated for the local population. This verification method is simple, inexpensive, and can be performed by any medical laboratory.

  2. Verification of chemistry reference ranges using a simple method in sub-Saharan Africa

    Directory of Open Access Journals (Sweden)

    Irith De Baetselier

    2016-10-01

    Full Text Available Background: Chemistry safety assessments are interpreted by using chemistry reference ranges (CRRs. Verification of CRRs is time consuming and often requires a statistical background. Objectives: We report on an easy and cost-saving method to verify CRRs. Methods: Using a former method introduced by Sigma Diagnostics, three study sites in sub- Saharan Africa, Bondo, Kenya, and Pretoria and Bloemfontein, South Africa, verified the CRRs for hepatic and renal biochemistry assays performed during a clinical trial of HIV antiretroviral pre-exposure prophylaxis. The aspartate aminotransferase/alanine aminotransferase, creatinine and phosphorus results from 10 clinically-healthy participants at the screening visit were used. In the event the CRRs did not pass the verification, new CRRs had to be calculated based on 40 clinically-healthy participants. Results: Within a few weeks, the study sites accomplished verification of the CRRs without additional costs. The aspartate aminotransferase reference ranges for the Bondo, Kenya site and the alanine aminotransferase reference ranges for the Pretoria, South Africa site required adjustment. The phosphorus CRR passed verification and the creatinine CRR required adjustment at every site. The newly-established CRR intervals were narrower than the CRRs used previously at these study sites due to decreases in the upper limits of the reference ranges. As a result, more toxicities were detected. Conclusion: To ensure the safety of clinical trial participants, verification of CRRs should be standard practice in clinical trials conducted in settings where the CRR has not been validated for the local population. This verification method is simple, inexpensive, and can be performed by any medical laboratory.

  3. Typologies of altruistic and financial motivations for research participation: A qualitative study of MSM in HIV vaccine trials

    Science.gov (United States)

    Chin, Lisa J; Berenson, Jacqueline A.; Klitzman, Robert L

    2016-01-01

    Questions arise concerning participants’ motives in risky studies, such as HIV vaccine trials (HVTs). We interviewed in-depth 20 gay/bisexual men. Participants described both altruistic and non-altruistic motives. Altruistic motivations emerged primarily, with nine typologies: 1) cultural; 2) community-related; 3) familial; 4) religious; 5) professional; 6) political (e.g., HIV activism); 7) moral (e.g., making up for past wrongs); 8) existential (e.g., providing sense of meaning); and 9) other psychological (e.g., emotional gratification). Views of compensation varied: not a factor (55%); added incentive (25%); main motivator, but in conjunction with altruism (15%); and primary motivator (5%). HVT participants thus often have both altruistic and financial motives, and related typologies emerged. These findings have critical implications for studies on HIV, other conditions, and research ethics. PMID:28251864

  4. Clinical Trials

    Medline Plus

    Full Text Available ... III clinical trial is required to have a Data and Safety Monitoring Board (DSMB). This board consists of a group of research and study topic experts. The NIH also requires DSMBs for large trials comparing alternative strategies for diagnosis or treatment. In addition, the NIH ...

  5. Clinical Trials

    Medline Plus

    Full Text Available ... harmful. However, an approach that works well in the lab or animals doesn't always work well in people. Thus, research in humans is needed. For safety purposes, clinical trials start ... more about the new approach's risks and benefits. A clinical trial ...

  6. 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

  7. Pragmatic Cluster Randomized Trials Using Covariate Constrained Randomization: A Method for Practice-based Research Networks (PBRNs).

    Science.gov (United States)

    Dickinson, L Miriam; Beaty, Brenda; Fox, Chet; Pace, Wilson; Dickinson, W Perry; Emsermann, Caroline; Kempe, Allison

    2015-01-01

    Cluster randomized trials (CRTs) are useful in practice-based research network translational research. However, simple or stratified randomization often yields study groups that differ on key baseline variables when the number of clusters is small. Unbalanced study arms constitute a potentially serious methodological problem for CRTs. Covariate constrained randomization with data on relevant variables before randomization was used to achieve balanced study arms in 2 pragmatic CRTs. In study 1, 16 counties in Colorado were randomized to practice-based or population-based reminder recall for vaccinating children ages 19 to 35 months. In study 2, 18 primary care practices were randomized to computer decision support plus practice facilitation versus computer decision support alone to improve care for patients with stage 3 and 4 chronic kidney disease. For each study, a set of optimal randomizations, which minimized differences of key variables between study arms, was identified from the set of all possible randomizations. Differences between study arms were smaller in the optimal versus remaining randomizations. Even for the randomization in the optimal set with the largest difference between groups, study arms did not differ significantly on any variable for either study (P > .05). Covariate constrained randomization, which restricts the full randomization set to a subset in which differences between study arms are minimized, is a useful tool for achieving balanced study arms in CRTs. Because of the increasing recognition of the risk of imbalance in CRTs and implications for interpreting study findings, procedures of this type should be considered in designing practice-based or community-based trials. © Copyright 2015 by the American Board of Family Medicine.

  8. Sustaining Housing First After a Successful Research Demonstration Trial: Lessons Learned in a Large Urban Center.

    Science.gov (United States)

    Kumar, Nishi; Plenert, Erin; Hwang, Stephen W; O'Campo, Patricia; Stergiopoulos, Vicky

    2017-07-01

    This study aimed to identify challenges and facilitators of sustaining a Housing First intervention at the conclusion of a research demonstration project in Toronto. This qualitative study included key informant interviews with organizational leaders (N=13) and focus groups with service team members (N=14) and program participants (N=9) of the At Home/Chez Soi Research Demonstration Project. Thematic analysis was used to identify key themes related to sustainability of Housing First beyond the demonstration phase. Factors that helped secure long-term funding support for Housing First included the positive findings of a rigorous evaluation, early stakeholder engagement, and strong local leadership. Reduced funding, poor intersectoral integration, and lack of central oversight threatened fidelity to the evidence-based model and challenged sustainability. Evidence-based complex interventions such as Housing First require robust intersectoral collaboration and flexible systems for funding and monitoring to ensure continuing model fidelity and responsiveness to changing contexts.

  9. 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

  10. 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…

  11. A verification environment for bigraphs

    DEFF Research Database (Denmark)

    Perrone, Gian David; Debois, Søren; Hildebrandt, Thomas

    2013-01-01

    We present the BigMC tool for bigraphical reactive systems that may be instantiated as a verification tool for any formalism or domain-specific modelling language encoded as a bigraphical reactive system. We introduce the syntax and use of BigMC, and exemplify its use with two small examples......: a textbook “philosophers” example, and an example motivated by a ubiquitous computing application. We give a tractable heuristic with which to approximate interference between reaction rules, and prove this analysis to be safe. We provide a mechanism for state reachability checking of bigraphical reactive...

  12. Homoeopathic pathogenetic trial of Withania somnifera: A multicentric, double-blind, randomised, placebo-controlled trial

    Directory of Open Access Journals (Sweden)

    Pritha Mehra

    2017-01-01

    Full Text Available Background: Homoeopathic drug proving being the first step in finding the pathogenetic powers of a drug is an integral part of Homoeopathic system of medicine. Objective: To elicit the pathogenetic response of Withania somnifera in homoeopathic potencies on healthy human provers. Materials and Methods: A multicentre, randomised, double-blind, placebo-controlled trial was conducted at four centres under Central Council for Research in Homoeopathy. Proving was conducted on 63 relatively healthy provers. All the provers were given 12 doses of placebo divided into 4 doses/day for 3 days during the first phase of the trial. After randomisation, 43 provers in the intervention group were given W. somnifera in 6C and 30C potencies in two phases. In the placebo group, 20 provers were administered unmedicated globules. The symptoms and signs manifested during the trial were noted down by the provers, elaborated by the proving masters and the data compilation on W. somnifera was done at proving-cum-data processing cell. Results: Out of 43 provers who were on actual drug trial, only 15 provers manifested 39 symptoms. The symptoms have been manifested predominantly in 30C potency. Among the objective findings, the drug has shown its effect on kidney, ovaries and helminthic infestation. Conclusion: The pathogenetic response elicited during this trial expands the scope of the use of W. somnifera and needs to be further validated by clinical verification study.

  13. Verification of industrial x-ray machine: MINTs experience

    International Nuclear Information System (INIS)

    Aziz Amat; Saidi Rajab; Eesan Pasupathi; Saipo Bahari Abdul Ratan; Shaharudin Sayuti; Abd Nassir Ibrahim; Abd Razak Hamzah

    2005-01-01

    Radiation and electrical safety of the industrial x-ray equipment required to meet Atomic Energy Licensing Board(AELB) guidelines ( LEM/TEK/42 ) at the time of installation and subsequently a periodic verification should be ensured. The purpose of the guide is to explain the requirements employed in conducting the test on industrial x-ray apparatus and be certified in meeting with our local legislative and regulation. Verification is aimed to provide safety assurance information on electrical requirements and the minimum radiation exposure to the operator. This regulation is introduced on new models imported into the Malaysian market. Since June, 1997, Malaysian Institute for Nuclear Technology Research (MINT) has been approved by AELB to provide verification services to private company, government and corporate body throughout Malaysia. Early January 1997, AELB has made it mandatory that all x-ray equipment for industrial purpose (especially Industrial Radiography) must fulfill certain performance test based on the LEM/TEK/42 guidelines. MINT as the third party verification encourages user to improve maintenance of the equipment. MINT experiences in measuring the performance on intermittent and continuous duty rating single-phase industrial x-ray machine in the year 2004 indicated that all of irradiating apparatus tested pass the test and met the requirements of the guideline. From MINT record, 1997 to 2005 , three x-ray models did not meet the requirement and thus not allowed to be used unless the manufacturers willing to modify it to meet AELB requirement. This verification procedures on electrical and radiation safety on industrial x-ray has significantly improved the the maintenance cultures and safety awareness in the usage of x-ray apparatus in the industrial environment. (Author)

  14. Nonlinear region of attraction analysis for hypersonic flight vehicles’ flight control verification

    OpenAIRE

    Jie Chen; Cun Bao Ma; Dong Song

    2017-01-01

    The stability analysis method based on region of attraction is proposed for the hypersonic flight vehicles’ flight control verification in this article. Current practice for hypersonic flight vehicles’ flight control verification is largely dependent on linear theoretical analysis and nonlinear simulation research. This problem can be improved by the nonlinear stability analysis of flight control system. Firstly, the hypersonic flight vehicles’ flight dynamic model is simplified and fitted by...

  15. Particularities of Verification Processes for Distributed Informatics Applications

    Directory of Open Access Journals (Sweden)

    Ion IVAN

    2013-01-01

    Full Text Available This paper presents distributed informatics applications and characteristics of their development cycle. It defines the concept of verification and there are identified the differences from software testing. Particularities of the software testing and software verification processes are described. The verification steps and necessary conditions are presented and there are established influence factors of quality verification. Software optimality verification is analyzed and some metrics are defined for the verification process.

  16. Response rate, response time, and economic costs of survey research: A randomized trial of practicing pharmacists.

    Science.gov (United States)

    Hardigan, Patrick C; Popovici, Ioana; Carvajal, Manuel J

    2016-01-01

    There is a gap between increasing demands from pharmacy journals, publishers, and reviewers for high survey response rates and the actual responses often obtained in the field by survey researchers. Presumably demands have been set high because response rates, times, and costs affect the validity and reliability of survey results. Explore the extent to which survey response rates, average response times, and economic costs are affected by conditions under which pharmacist workforce surveys are administered. A random sample of 7200 U.S. practicing pharmacists was selected. The sample was stratified by delivery method, questionnaire length, item placement, and gender of respondent for a total of 300 observations within each subgroup. A job satisfaction survey was administered during March-April 2012. Delivery method was the only classification showing significant differences in response rates and average response times. The postal mail procedure accounted for the highest response rates of completed surveys, but the email method exhibited the quickest turnaround. A hybrid approach, consisting of a combination of postal and electronic means, showed the least favorable results. Postal mail was 2.9 times more cost effective than the email approach and 4.6 times more cost effective than the hybrid approach. Researchers seeking to increase practicing pharmacists' survey participation and reduce response time and related costs can benefit from the analytical procedures tested here. Copyright © 2016 Elsevier Inc. All rights reserved.

  17. Portal verification for breast cancer radiotherapy

    International Nuclear Information System (INIS)

    Petkovska, Sonja; Pejkovikj, Sasho; Apostolovski, Nebojsha

    2013-01-01

    At the University Clinic in Skopje, breast cancer irradiation is being planned and performed by using a mono-iso centrical method, which means that a unique isocenter (I C) for all irradiation fields is used. The goal of this paper is to present the patient’s position in all coordinates before the first treatment session, relative to the position determined during the CT simulation. Deviation of up to 5 mm is allowed. The analysis was made by using a portal verification. Sixty female patients at random selection are reviewed. The matching results show that for each patient deviation exists at least on one axis. The largest deviations are in the longitudinal direction (head-feet) up to 4 mm, mean 1.8 mm. In 60 out of 85 analysed fields, the deviation is towards the head. In lateral direction, median deviation is 1.1 mm and in 65% of the analysed portals those deviations are in medial direction – contralateral breast which can increases the dose in the lung and in the contralateral breast. This deviation for supraclavicular field can increase the dose in the spinal cord. Although these doses are well below the limit, this fact should be taken into account in setting the treatment fields. The final conclusion from the research is that despite of the fact we are dealing with small deviations, in conditions when accuracy in positioning is done with portal, the portal verification needs to be done in the coming weeks of the treatment, not only before the first treatment. This provides information for an intra fractional set-up deviation. (Author)

  18. Clinical Trials

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  20. Methods of Verification, Accountability and Control of Special Nuclear Material

    International Nuclear Information System (INIS)

    Stewart, J.E.

    1999-01-01

    This session demonstrates nondestructive assay (NDA) measurement, surveillance and analysis technology required to protect, control and account (MPC and A) for special nuclear materials (SNM) in sealed containers. These measurements, observations and analyses comprise state-of-the art, strengthened, SNM safeguards systems. Staff member specialists, actively involved in research, development, training and implementation worldwide, will present six NDA verification systems and two software tools for integration and analysis of facility MPC and A data