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Sample records for epic clinical trial

  1. The EPIC nitinol stent system in the treatment of iliac artery lesions: one-year results from the ORION clinical trial.

    Science.gov (United States)

    Clair, Daniel G; Adams, Julie; Reen, Bernard; Feldman, Robert; Starr, Jean; Diaz-Cartelle, Juan; Dawkins, Keith D

    2014-04-01

    To report the 1-year results of a pivotal study for a new-generation nitinol stent for the treatment of iliac atherosclerotic lesions. The ORION trial (ClinicalTrials.gov identifier NCT00896337) was a single-arm, non-randomized, prospective, multicenter clinical trial that enrolled 125 patients (81 men; mean age 61.1±9.3 years) implanted with the EPIC self-expanding nitinol stent system in 166 de novo or restenotic iliac artery lesions ≤13 cm long. The primary endpoint was the 9-month major adverse event rate [i.e., device- or procedure-related death within 30 days, myocardial infarction during the index hospitalization, target vessel revascularization (TVR), or index limb amputation]. Follow-up occurred at hospital discharge and at 1, 9, and 12 months. An independent core laboratory evaluated ultrasound results at 1, 9, and 12 months. The primary endpoint met the prespecified performance goal, with only 3.4% (4/117) of patients experiencing a major adverse event by 9 months (p<0.0001). By 12 months, 6 (5.4%) of 111 patients had TVR; none had an index limb amputation. The ankle-brachial index, Walking Impairment Questionnaire, and Rutherford classifications all showed sustained improvements through 12 months. Primary patency was 94.4% with comparable results for lesions classified as complex (TASC II C/D 95.5%) or non-complex (TASC II A/B 95.0%). The EPIC stent system demonstrated safety and effectiveness through 12 months, including improvements for complex lesions. The EPIC stent is a viable alternative to surgery for patients with either complex or non-complex lesions.

  2. Feasibility of the Enhancing Participation In the Community by improving Wheelchair Skills (EPIC Wheels) program: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Giesbrecht, Edward M; Miller, William C; Eng, Janice J; Mitchell, Ian M; Woodgate, Roberta L; Goldsmith, Charles H

    2013-10-24

    Many older adults rely on a manual wheelchair for mobility but typically receive little, if any, training on how to use their wheelchair effectively and independently. Standardized skill training is an effective intervention, but limited access to clinician trainers is a substantive barrier. Enhancing Participation in the Community by Improving Wheelchair Skills (EPIC Wheels) is a 1-month monitored home training program for improving mobility skills in older novice manual wheelchair users, integrating principles from andragogy and social cognitive theory. The purpose of this study is to determine whether feasibility indicators and primary clinical outcome measures of the EPIC Wheels program are sufficiently robust to justify conducting a subsequent multi-site randomized controlled trial. A 2 × 2 factorial randomized controlled trial at two sites will compare improvement in wheelchair mobility skills between an EPIC Wheels treatment group and a computer-game control group, with additional wheelchair use introduced as a second factor. A total of 40 community-dwelling manual wheelchair users at least 55 years old and living in two Canadian metropolitan cities (n = 20 × 2) will be recruited. Feasibility indicators related to study process, resources, management, and treatment issues will be collected during data collection and at the end of the study period, and evaluated against proposed criteria. Clinical outcome measures will be collected at baseline (pre-randomization) and post-intervention. The primary clinical outcome measure is wheelchair skill capacity, as determined by the Wheelchair Skills Test, version 4.1. Secondary clinical outcome measures include wheelchair skill safety, satisfaction with performance, wheelchair confidence, life-space mobility, divided-attention, and health-related quality of life. The EPIC Wheels training program offers several innovative features. The convenient, portable, economical, and adaptable tablet-based, home program model

  3. Psychometric Assessment of the Chinese Version of the Abbreviated Expanded Prostate Cancer Index Composite (EPIC-26) and the Clinical Practice Version (EPIC-CP) in Chinese Men With Prostate Cancer.

    Science.gov (United States)

    Lam, Wendy W T; Tse, Michael A; Ng, Chris N L; Chung, Edward K M; Fielding, Richard

    2017-06-01

    The Expanded Prostate Cancer Index Composite (EPIC) instrument was designed to assess a range of health-related quality-of-life issues specifically relevant to patients with prostate cancer. This study examined the validity and reliability of Chinese versions of the 26-item EPIC and of the 16-item EPIC for Clinical Practice (EPIC-CP) in Chinese patients with prostate cancer. A Chinese version of the 26-item EPIC and the 16-item EPIC-CP were self-completed by 252 Chinese patients with prostate cancer who were recruited from three community-based cancer service centers. Confirmatory factors analysis assessed the factor structures of the EPIC and the EPIC-CP. Internal consistency and construct and clinical validities of the factor structures were assessed. Confirmatory factor analysis revealed that the original factor structure of both EPIC-26 and EPIC-CP showed good fit to this sample. A correlated model was superior to a hierarchical model in both EPIC-26 and EPIC-CP supporting the utility of the domain scores over the total scores. Cronbach α ranged from 0.55 to 0.91 for EPIC-26 and 0.44 to 0.67 for EPIC-CP. Construct validity was supported by correlations between EPIC-26/EPIC-CP and psychological distress measures. Clinical validity was supported by differentiation between patients with and without prostatectomy. These Chinese versions of the five-factor EPIC-26 and the EPIC-CP are valid and practical measures for assessing a range of health-related quality-of-life issues related to the diagnosis and treatment of prostate cancer, highlighting their utility in assessing health-related quality of life for patients diagnosed with prostate cancer. Copyright © 2017 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.

  4. Stereotactic Body Radiation Therapy for Prostate Cancer: What is the Appropriate Patient-Reported Outcome for Clinical Trial Design?

    Directory of Open Access Journals (Sweden)

    Jennifer Ai-Lian Woo

    2015-03-01

    Full Text Available Purpose: Stereotactic body radiation therapy (SBRT is increasingly utilized as primary treatment for clinically localized prostate cancer. Consensus regarding the appropriate patient-reported outcome (PRO endpoints for clinical trials for early stage prostate cancer RT is lacking. To aid in trial design, this study presents PROs over 36 months following SBRT for clinically localized prostate cancer. Methods: 174 hormone-naïve patients were treated with 35-36.25 Gy SBRT in 5 fractions. Patients completed the EPIC-26 questionnaire at baseline and all follow-ups; the proportion of patients developing a clinically significant decline in each EPIC domain was determined. The minimally important difference (MID was defined as a change of one-half SD from the baseline. Per RTOG 0938, we examined the percentage of patients who reported decline in EPIC urinary summary score of >2 points and EPIC bowel summary score of >5 points from baseline to one year. Results: 174 patients received SBRT with minimum follow-up of 36 months. The proportion of patients reporting a clinically significant decline in EPIC urinary/bowel scores was 34%/30%, 40%/32.2%, and 32.8%/21.5% at 6, 12, and 36 months. The percentage of patients reporting decline in the EPIC urinary summary score of >2 points was 43.2%, 51.6% and 41.8% at 6, 12, and 36 months. The percentage of patients reporting decline in EPIC bowel domain summary score of >5 points was 29.6% 29% and 22.4% at 6, 12, and 36 months. Conclusion: Our treatment protocol meets the RTOG 0938 criteria for advancing to a Phase III trial compared to conventionally fractionated RT. Between 12-36 months, the proportion of patients reporting decrease in both EPIC urinary and bowel scores declined, suggesting late improvement in these domains. Further investigation is needed to elucidate 1 which domains bear the greatest influence on post-treatment QOL, and 2 at what time point PRO endpoint(s should be assessed.

  5. Implementation of Epic Beaker Clinical Pathology at an academic medical center

    Directory of Open Access Journals (Sweden)

    Matthew D Krasowski

    2016-01-01

    Full Text Available Background: Epic Beaker Clinical Pathology (CP is a relatively new laboratory information system (LIS operating within the Epic suite of software applications. To date, there have not been any publications describing implementation of Beaker CP. In this report, we describe our experience in implementing Beaker CP version 2012 at a state academic medical center with a go-live of August 2014 and a subsequent upgrade to Beaker version 2014 in May 2015. The implementation of Beaker CP was concurrent with implementations of Epic modules for revenue cycle, patient scheduling, and patient registration. Methods: Our analysis covers approximately 3 years of time (2 years preimplementation of Beaker CP and roughly 1 year after using data summarized from pre- and post-implementation meetings, debriefings, and the closure document for the project. Results: We summarize positive aspects of, and key factors leading to, a successful implementation of Beaker CP. The early inclusion of subject matter experts in the design and validation of Beaker workflows was very helpful. Since Beaker CP does not directly interface with laboratory instrumentation, the clinical laboratories spent extensive preimplementation effort establishing middleware interfaces. Immediate challenges postimplementation included bar code scanning and nursing adaptation to Beaker CP specimen collection. The most substantial changes in laboratory workflow occurred with microbiology orders. This posed a considerable challenge with microbiology orders from the operating rooms and required intensive interventions in the weeks following go-live. In postimplementation surveys, pathology staff, informatics staff, and end-users expressed satisfaction with the new LIS. Conclusions: Beaker CP can serve as an effective LIS for an academic medical center. Careful planning and preparation aid the transition to this LIS.

  6. J-TEXT-EPICS: An EPICS toolkit attempted to improve productivity

    International Nuclear Information System (INIS)

    Zheng, Wei; Zhang, Ming; Zhang, Jing; Zhuang, Ge

    2013-01-01

    Highlights: • Tokamak control applications can be developed in very short period with J-TEXT-EPICS. • J-TEXT-EPICS enables users to build control applications with device-oriented functions. • J-TEXT-EPICS is fully compatible with EPICS Channel Access protocol. • J-TEXT-EPICS can be easily extended by plug-ins and drivers. -- Abstract: The Joint Texas Experimental Tokamak (J-TEXT) team has developed a new software toolkit for building Experimental Physics and Industrial Control System (EPICS) control applications called J-TEXT-EPICS. It aims to improve the development efficiency of control applications. With device-oriented features, it can be used to set or obtain the configuration or status of a device as well as invoke methods on a device. With its modularized design, its functions can be easily extended. J-TEXT-EPICS is completely compatible with the original EPICS Channel Access protocol and can be integrated into existing EPICS control systems smoothly. It is fully implemented in C number sign, thus it will benefit from abundant resources in.NET Framework. The J-TEXT control system is build with this toolkit. This paper presents the design and implementation of J-TEXT EPICS as well as its application in the J-TEXT control system

  7. EPICS release 3.11 specific documentation -- EPICS release notes for 3.11

    International Nuclear Information System (INIS)

    1994-01-01

    EPICS release 3.11 is now ready for user testing. A person who wants to set up a simplified application environment to boot an IOC and create databases using R3.11 should follow the directions in Appendix B, page 27, of the EPICS Source/Release Control Manual, Sept. 20, 1993. The R3.11 EPICS path at ANL/APS is /net/phebos/epics/R3.11 so the command to get the new release is /net/phebos/epics/R3.11/Unix/share/bin/getrel /net/phebos/epics/R3.11. An existing R3.8 short form report can be copied to this new directory and used to create a database. ANL/APS is currently testing an Application Developers Source/Release control system. It is not yet ready for general distribution. Attached are the EPICS R3.11 release notes

  8. Integrating EPICS and MDSplus

    International Nuclear Information System (INIS)

    Mastrovito, D.; Davis, W.; Dong, J.; Roney, P.; Sichta, P.

    2006-01-01

    The National Spherical Torus Experiment (NSTX) has been in operation at the Princeton Plasma Physics Laboratory (PPPL) since 1999. Since then, NSTX has made use of the Experimental Physics and Industrial Control System (EPICS) and MDSplus software packages, among others for control and data acquisition. To date, the two products have been integrated using special 'bridging' programs that include client-components for the EPICS and MDSplus servers. Recent improvements in the EPICS software have made it easier to develop a direct interface with MDSplus. This paper will describe the new EPICS extensions developed at PPPL that provide: (1) a direct data interface between EPICS process variables and MDSplus nodes; and (2) an interface between EPICS events and MDSplus events. These extensions have been developed for use with EPICS on Solaris and are currently being modified for use on real-time operating systems. Separately, an XML-RPC client was written to access EPICS 'trended' data, sampled usually once per minute during a 24 h period. The client extracts and writes a day's worth of trended data to a 'daily' MDSplus tree

  9. EPICS Application Based on RTEMS

    International Nuclear Information System (INIS)

    Shi Haoli; Wang Chunhong; Tang Jingyu

    2009-01-01

    At present, in the accelerator field all over the world, the control system is established with EPICS, which is a configuration software package based on Ethernet and distributed control system. Early version of EPICS was developed based on VxWorks. Now, EPICS international collaboration group is dedicating to supporting open source, free RTEMS, and extending RTEMS into the newer version of EPICS3.14. The paper illustrates the development, characteristic of RTEMS, compares the performances of several ordinary RTOS, builds RTEMS operating system based on MVME5500, and finally presents an EPICS application example on RTEMS. (authors)

  10. Challenges in Comparative Oral Epic

    Directory of Open Access Journals (Sweden)

    John Miles Foley

    2012-10-01

    Full Text Available Originally written in 2001 and subsequently published in China, this collaborative essay explores five questions central to comparative oral epic with regard to Mongolian, South Slavic, ancient Greek, and Old English traditions: “What is a poem in oral epic tradition?” “What is a typical scene or theme in oral epic tradition?” “What is a poetic line in oral epic tradition?” “What is a formula in an oral epic tradition?” “What is the register in oral epic poetry?” Now available for the first time in English, this essay reflects a foundational stage of what has become a productive and long-term collaboration between the Center for Studies in Oral Tradition and the Institute of Ethnic Literature of the Chinese Academy of Social Sciences.

  11. PROCTITIS ONE WEEK AFTER STEREOTACTIC BODY RADIATION THERAPY FOR PROSTATE CANCER: IMPLICATIONS FOR CLINICAL TRIAL DESIGN

    Directory of Open Access Journals (Sweden)

    Ima Paydar

    2016-07-01

    Full Text Available Background: Proctitis following prostate cancer radiation therapy is a primary determinant of quality of life (QOL. While previous studies have assessed acute rectal morbidity at 1 month after stereotactic body radiotherapy (SBRT, little data exist on the prevalence and severity of rectal morbidity within the first week following treatment. This study reports the acute bowel morbidity one week following prostate SBRT. Materials and methods: Between May 2013 and August 2014, 103 patients with clinically localized prostate cancer were treated with 35 to 36.25 Gy in five fractions using robotic SBRT delivered on a prospective clinical trial. Bowel toxicity was graded using the Common Terminology Criteria for Adverse Events version 4.0 (CTCAEv.4. Bowel QOL was assessed using EPIC-26 questionnaire bowel domain at baseline, one week, one month, and three months. Time-dependent changes in bowel symptoms were statistically compared using the Wilcoxon signed-rank test. Clinically significant change was assessed by the minimally important difference (MID in EPIC score. This was defined as a change of one-half standard deviation (SD from the baseline score. Results: One hundred and three patients with a minimum of three months of follow-up were analyzed. The cumulative incidence of acute grade 2 GI toxicity was 23%. There were no acute ≥ grade 3 bowel toxicities. EPIC bowel summary scores maximally declined at 1 week after SBRT (-13.9, p<0.0001 before returning to baseline at three months after SBRT (+0.03, p=0.94. Prior to treatment, 4.9% of men reported that their bowel bother was a moderate to big problem. This increased to 28.4% (p<0.0001 one week after SBRT and returned to baseline at three months after SBRT (0.0%, p=0.66. Only the bowel summary and bowel bother score declines at 1 week met the MID threshold for clinically significant change. Conclusion: The rate and severity of acute proctitis following prostate SBRT peaked at one week after

  12. EPICS MySQL Archiver - integration between EPICS and MySQL

    International Nuclear Information System (INIS)

    Roy, A.; Bhole, R.B.; Pal, S.; Sarkar, D.

    2012-01-01

    The performance evaluation and analysis of intersystem dependency of the various subsystems of the Superconducting Cyclotron (SCC) demand a well configured data logging, archiving and historic analysis facility for large number of control parameters along with on-line failure analysis facility of every system. Experimental Physics and Industrial Control System (EPICS) is used as development architecture of the control system of these systems with MySQL as database for large amount of relational data management. This combination requires integration between EPICS and MySQL server. For this purpose, MySQL Archiver as an EPICS Extension is developed for data logging and archiving of control parameters into MySQL database. This extension also provides a web based tool for online monitoring of control parameters and historic analysis of archived data. This paper describes the software architecture, implementation, as well as method of configuration for any other EPICS based control system as a utility. This facility is also elaborated with examples, web page views and experiences of deploying it in SCC. (author)

  13. EPICS V4 in Python

    International Nuclear Information System (INIS)

    Guobao Shen; Kraimer, M.; Davidsaver, M.

    2012-01-01

    At NSLS-II, Python has been selected as the primary development language for physics applications. Interest in Python as a rapid application development environment continues to grow. Many large experimental scientific facilities have adopted Python for beam commissioning and the operation. The EPICS control system framework has become the de facto standard for the control of large experimental facilities, where it is in use in over 100 facilities. The next version of EPICS (EPICS V4), under active development will extend the support for physics applications, data acquisition, and data analysis. Python support for EPICS V4 will provide an effective framework to address these requirements. This paper presents design, development and status of activities focused on EPICS V4 in Python

  14. Calibration of the DSCOVR EPIC Visible and NIR Channels using MODIS Terra and Aqua Data and EPIC Lunar Observations

    Science.gov (United States)

    Geogdzhayev, Igor V.; Marshak, Alexander

    2018-01-01

    The unique position of the Deep Space Climate Observatory (DSCOVR) Earth Polychromatic Imaging Camera (EPIC) at the Lagrange 1 point makes an important addition to the data from currently operating low Earth orbit observing instruments. EPIC instrument does not have an onboard calibration facility. One approach to its calibration is to compare EPIC observations to the measurements from polar-orbiting radiometers. Moderate Resolution Imaging Spectroradiometer (MODIS) is a natural choice for such comparison due to its well-established calibration record and wide use in remote sensing. We use MODIS Aqua and Terra L1B 1km reflectances to infer calibration coefficients for four EPIC visible and NIR channels: 443, 551, 680 and 780 nm. MODIS and EPIC measurements made between June 2015 and 2016 are employed for comparison. We first identify favorable MODIS pixels with scattering angle matching temporarily collocated EPIC observations. Each EPIC pixel is then spatially collocated to a subset of the favorable MODIS pixels within 25 km radius. Standard deviation of the selected MODIS pixels as well as of the adjacent EPIC pixels is used to find the most homogeneous scenes. These scenes are then used to determine calibration coefficients using a linear regression between EPIC counts/sec and reflectances in the close MODIS spectral channels. We present thus inferred EPIC calibration coefficients and discuss sources of uncertainties. The lunar EPIC observations are used to calibrate EPIC O2 absorbing channels (688 and 764 nm), assuming that there is a small difference between moon reflectances separated by approx.10 nm in wavelength provided the calibration factors of the red (680 nm) and near-IR (780 nm) are known from comparison between EPIC and MODIS.

  15. Clinical Trials

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

  16. Experience using EPICS on PC platforms

    International Nuclear Information System (INIS)

    Hill, J.O.; Kasemire, K.U.

    1997-03-01

    The Experimental Physics and Industrial Control System (EPICS) has been widely adopted in the accelerator community. Although EPICS is available on many platforms, the majority of implementations have used UNIX workstations as clients, and VME- or VXI-based processors for distributed input output controllers. Recently, a significant portion of EPICS has been ported to personal computer (PC) hardware platforms running Microsoft's operating systems, and also Wind River System's real time vxWorks operating system. This development should significantly reduce the cost of deploying EPICS systems, and the prospect of using EPICS together with the many high quality commercial components available for PC platforms is also encouraging. A hybrid system using both PC and traditional platforms is currently being implemented at LANL for LEDA, the low energy demonstration accelerator under construction as part of the Accelerator Production of Tritium (APT) project. To illustrate these developments the authors compare their recent experience deploying a PC-based EPICS system with experience deploying similar systems based on traditional (UNIX-hosted) EPICS hardware and software platforms

  17. Calibration of the DSCOVR EPIC visible and NIR channels using MODIS Terra and Aqua data and EPIC lunar observations

    Directory of Open Access Journals (Sweden)

    I. V. Geogdzhayev

    2018-01-01

    Full Text Available The unique position of the Deep Space Climate Observatory (DSCOVR Earth Polychromatic Imaging Camera (EPIC at the Lagrange 1 point makes an important addition to the data from currently operating low Earth orbit observing instruments. EPIC instrument does not have an onboard calibration facility. One approach to its calibration is to compare EPIC observations to the measurements from polar-orbiting radiometers. Moderate Resolution Imaging Spectroradiometer (MODIS is a natural choice for such comparison due to its well-established calibration record and wide use in remote sensing. We use MODIS Aqua and Terra L1B 1 km reflectances to infer calibration coefficients for four EPIC visible and NIR channels: 443, 551, 680 and 780 nm. MODIS and EPIC measurements made between June 2015 and 2016 are employed for comparison. We first identify favorable MODIS pixels with scattering angle matching temporarily collocated EPIC observations. Each EPIC pixel is then spatially collocated to a subset of the favorable MODIS pixels within 25 km radius. Standard deviation of the selected MODIS pixels as well as of the adjacent EPIC pixels is used to find the most homogeneous scenes. These scenes are then used to determine calibration coefficients using a linear regression between EPIC counts s−1 and reflectances in the close MODIS spectral channels. We present thus inferred EPIC calibration coefficients and discuss sources of uncertainties. The lunar EPIC observations are used to calibrate EPIC O2 absorbing channels (688 and 764 nm, assuming that there is a small difference between moon reflectances separated by  ∼  10 nm in wavelength and provided the calibration factors of the red (680 nm and NIR (780 nm are known from comparison between EPIC and MODIS.

  18. Clinical Trials

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    Full Text Available ... questions and clinical trials. Optimizing our Clinical Trials Enterprise NHLBI has a strong tradition of supporting clinical ... multi-pronged approach to Optimize our Clinical Trials Enterprise that will make our clinical trials enterprise even ...

  19. Usability of human Infinium MethylationEPIC BeadChip for mouse DNA methylation studies.

    Science.gov (United States)

    Needhamsen, Maria; Ewing, Ewoud; Lund, Harald; Gomez-Cabrero, David; Harris, Robert Adam; Kular, Lara; Jagodic, Maja

    2017-11-15

    The advent of array-based genome-wide DNA methylation methods has enabled quantitative measurement of single CpG methylation status at relatively low cost and sample input. Whereas the use of Infinium Human Methylation BeadChips has shown great utility in clinical studies, no equivalent tool is available for rodent animal samples. We examined the feasibility of using the new Infinium MethylationEPIC BeadChip for studying DNA methylation in mouse. In silico, we identified 19,420 EPIC probes (referred as mEPIC probes), which align with a unique best alignment score to the bisulfite converted reference mouse genome mm10. Further annotation revealed that 85% of mEPIC probes overlapped with mm10.refSeq genes at different genomic features including promoters (TSS1500 and TSS200), 1st exons, 5'UTRs, 3'UTRs, CpG islands, shores, shelves, open seas and FANTOM5 enhancers. Hybridization of mouse samples to Infinium Human MethylationEPIC BeadChips showed successful measurement of mEPIC probes and reproducibility between inter-array biological replicates. Finally, we demonstrated the utility of mEPIC probes for data exploration such as hierarchical clustering. Given the absence of cost and labor convenient genome-wide technologies in the murine system, our findings show that the Infinium MethylationEPIC BeadChip platform is suitable for investigation of the mouse methylome. Furthermore, we provide the "mEPICmanifest" with genomic features, available to users of Infinium Human MethylationEPIC arrays for mouse samples.

  20. EPICS system: an overview

    International Nuclear Information System (INIS)

    Bartlett, J.F.; Bobbitt, J.S.; Kramper, B.J.; Lahey, T.E.; MacKinnon, B.A.; West, R.E.

    1984-02-01

    This paper presents an overview of the EPICS control system at FERMILAB. EPICS is a distributed, multi-user, interactive system for the control and monitoring of particle beamlines at a high-energy experimental physics laboratory. The overview discusses the operating environment of the control system, the requirements which determined the design decisions, the hardware and software configurations, and plans for the future growth and enhancement of the present system. This paper is the first of three related papers on the EPICS system. The other two cover (1) the system structure and user interface and (2) RSX implementation issues

  1. Development of EPICS IOC for TPLC-32 platform

    International Nuclear Information System (INIS)

    Jain, Sanjay Kumar; Bhamra, Ratna; Kavalan, P.K.; Vaidya, U.W.

    2014-01-01

    Experimental Physics and Industrial Control System (EPICS) SCADA software package is popular worldwide for deploying accelerator control systems. EPICS base allows building server applications that interact with EPICS compliant lower level hardware, embedded systems, commercial PLCs on one side and facilitates seamless connectivity with EPICS clients on the other side. Large number of such lower level (EPICS complaint) networked systems work in collaborative environment for physics experiment. RCnD has developed a PLC platform, Trombay Programmable Logic Controller TPLC-32 for deploying C and I systems of NPP and allied utilities. This platform is now also being used for deploying accelerator C and I systems. Hence the activity of developing TPLC-32 interface with EPICS was taken up in RCnD. This paper introduces the architecture of the EPICS Input Output Controller (IOC) and describes the implementation of the EPICS SoftIOC for TPLC-32. It also describes Operator Interface developed using MEDM EPICS client for LEHIPA vacuum control system built using TPLC-32. (author)

  2. Clinical Trials

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  3. Clinical Trials

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  4. Clinical Trials

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  5. Clinical Trials

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  6. Development of EPICS channel access embedded ActiveX components for GUI development

    International Nuclear Information System (INIS)

    Roy, A.; Bhole, R.B.; Pal, S.

    2012-01-01

    The paper describes the integration of Experimental Physics and Industrial Control System (EPICS) Channel Access (CA) protocol and Microsoft ActiveX technology towards developing a generalize operator interface (OPI) building facility for Windows platform. EPICS is used as the development architecture of the control system in Superconducting Cyclotron (SCC). Considering the operators' familiarity and compatibility with third party software, it was decided to use MS-Windows platform at operator interface level in SCC during commission. Microsoft Visual Basic (VB) is used on trial basis as OPI building platform to incorporate user specific features e.g. file system access for data storage and analysis, user authentication at OPI level etc. A set of EPICS Channel Access embedded ActiveX components is developed to ease the programming complexity and reduce developmental time of the OPI for Windows platform. OPIs, developed using these components and containing hundreds of process parameters, are being used reliably over a considerable period of time. (author)

  7. Clinical Trials

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

  8. Clinical Trials

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  9. Clinical Trials

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  10. EPICS based DAQ system

    International Nuclear Information System (INIS)

    Cheng Weixing; Chen Yongzhong; Zhou Weimin; Ye Kairong; Liu Dekang

    2002-01-01

    EPICS is the most popular developing platform to build control system and beam diagnostic system in modern physics experiment facilities. An EPICS based data acquisition system was built in Redhat 6.2 operation system. The system is successfully used in the beam position monitor mapping, it improves the mapping process a lot

  11. 77 FR 73655 - Epic Marketplace, Inc., and Epic Media Group, LLC; Analysis of Proposed Consent Order To Aid...

    Science.gov (United States)

    2012-12-11

    ... action or make final the agreement's proposed order. Epic Marketplace, Inc. (``Epic'') is an advertising company that engages in online behavioral advertising, which is the practice of tracking a consumer's online activities in order to deliver advertising targeted to the consumer's interests. Epic is a wholly...

  12. Clinical Trials

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  13. EPIC229426032 b and EPIC246067459 b: discovery and characterization of two new transiting hot Jupiters from K2

    Science.gov (United States)

    Soto, M. G.; Díaz, M. R.; Jenkins, J. S.; Rojas, F.; Espinoza, N.; Brahm, R.; Drass, H.; Jones, M. I.; Rabus, M.; Hartman, J.; Sarkis, P.; Jordán, A.; Lachaume, R.; Pantoja, B.; Vučković, M.; Ciardi, D. R.; Crossfield, I.; Dressing, C.; Gonzales, E.; Hirsch, L.

    2018-05-01

    We report the discovery of two hot Jupiters orbiting the stars EPIC229426032 and EPIC246067459. We used photometric data from Campaign 11 and 12 of the Kepler K2 Mission and radial velocity data obtained using the HARPS, FEROS, and CORALIE spectrographs. EPIC229426032 b and EPIC246067459 b have masses of 1.60^{+0.11}_{-0.11} and 0.86^{+0.13}_{-0.12}Mjup, radii of 1.65^{+0.07}_{-0.08} and 1.30^{+0.15}_{-0.14} R_{jup}, and are orbiting their host stars in 2.18 and 3.20-day orbits, respectively. The large radius of EPIC229426032 b leads us to conclude that this candidate corresponds to a highly inflated hot Jupiter. EPIC2460674559 b has a radius consistent with theoretical models, considering the high incident flux falling on the planet. We consider EPIC229426032 b to be a excellent system for follow-up studies, since not only is it very inflated, but it also orbits a relatively bright star (V = 11.6).

  14. Clinical Trials

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    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 ...

  15. Carotid artery stenting in high surgical risk patients using the FiberNet embolic protection system: the EPIC trial results.

    Science.gov (United States)

    Myla, Subbarao; Bacharach, J Michael; Ansel, Gary M; Dippel, Eric J; McCormick, Daniel J; Popma, Jeffrey J

    2010-05-01

    The multicenter EPIC (FiberNet Embolic Protection System in Carotid Artery Stenting Trial) single-arm trial evaluated the 30-day outcomes of a new design concept for embolic protection during carotid artery stenting (CAS). Embolic protection filters available for use during CAS include fixed and over-the-wire systems that rely on embolic material capture within a "basket" structure. The FiberNet Embolic Protection System (EPS), which features a very low crossing profile, consists of a three-dimensional fiber-based filter distally mounted on a 0.014 inch guidewire with integrated aspiration during filter retrieval. The trial enrolled 237 patients from 26 centers. Demographics, clinical and lesion characteristics, as well as adverse events through a 30-day follow-up were recorded. The mean age of the patients was 74 years, 64% were male and 20% had symptomatic carotid artery disease. The combined major adverse event (MAE) rate at 30 days for all death, stroke, and myocardial infarction was 3.0%. There were three major strokes (two ischemic and one hemorrhagic) and two minor strokes (both ischemic) for a 2.1% 30-day stroke rate. The procedural technical success rate was 97.5% and macroscopic evidence of debris was reported in 90.9% of the procedures. The FiberNet EPS, used with commercially available stents, produced low stroke rates following CAS in high surgical risk patients presenting with carotid artery disease. The unique filter design including aspiration during retrieval may have contributed to the low 30-day stroke rate reported during CAS in patients considered at high risk for complications following carotid endarterectomy (CEA). Copyright 2010 Wiley-Liss, Inc.

  16. EPICS system: RSX implementation issues

    International Nuclear Information System (INIS)

    Lahey, T.E.; Bartlett, J.F.; Bobbitt, J.S.; Kramper, B.J.; MacKinnon, B.A.; West, R.E.

    1984-02-01

    This paper presents implementation details of the Experimental Physics Interactive Control System (EPICS). EPICS is used to control accelerated particle beams for high-energy physics experiments at the Fermi National Accelerator Laboratory. The topics discussed are: interprocessor communication, support of beamline terminals and devices, resource management, mapping, various problems, some solutions to the problems, performance measurement, and modifications and extensions to RSX-11M. This paper is the third of three related papers on the EPICS system. The other two cover (1) the system overview and (2) the system structure and user interface

  17. Clinical Trials

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    Full Text Available ... child to enroll. Also, children aged 7 and older often must agree (assent) to take part in clinical trials. Clinical trials for children have the same scientific safeguards as clinical trials for adults. For more information, go to "How Do Clinical ...

  18. Clinical Trials

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    Full Text Available ... clinical trials. If you're thinking about taking part in a clinical trial, find out ahead of time about costs and coverage. You should learn about the risks and benefits of any clinical trial before you agree to take part in the trial. Talk with your doctor about ...

  19. Clinical Trials

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    Full Text Available ... resources to the strategies and treatments that work best. How Clinical Trials Work If you take part in a clinical trial, you may get tests or treatments in a hospital, clinic, or doctor's office. In some ways, taking part in a clinical trial is different ...

  20. Clinical Trials

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    Full Text Available ... or vulnerable patients (such as children). A DSMB's role is to review data from a clinical trial ... a Clinical Trial If you're interested in learning more about, or taking part in, clinical trials, ...

  1. Clinical Trials

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    Full Text Available ... clinical trials are vital to the process of improving medical care. Many people volunteer because they want ... care costs for clinical trials. If you're thinking about taking part in a clinical trial, find ...

  2. Clinical Trials

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    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, ...

  3. EPIC: an Error Propagation/Inquiry Code

    International Nuclear Information System (INIS)

    Baker, A.L.

    1985-01-01

    The use of a computer program EPIC (Error Propagation/Inquiry Code) will be discussed. EPIC calculates the variance of a materials balance closed about a materials balance area (MBA) in a processing plant operated under steady-state conditions. It was designed for use in evaluating the significance of inventory differences in the Department of Energy (DOE) nuclear plants. EPIC rapidly estimates the variance of a materials balance using average plant operating data. The intent is to learn as much as possible about problem areas in a process with simple straightforward calculations assuming a process is running in a steady-state mode. EPIC is designed to be used by plant personnel or others with little computer background. However, the user should be knowledgeable about measurement errors in the system being evaluated and have a limited knowledge of how error terms are combined in error propagation analyses. EPIC contains six variance equations; the appropriate equation is used to calculate the variance at each measurement point. After all of these variances are calculated, the total variance for the MBA is calculated using a simple algebraic sum of variances. The EPIC code runs on any computer that accepts a standard form of the BASIC language. 2 refs., 1 fig., 6 tabs

  4. Clinical Trials

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    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 ...

  5. Clinical Trials

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    Full Text Available ... about your health or fill out forms about how you feel. Some people will need to travel or stay in hospitals to take part in clinical trials. For example, the National Institutes of Health Clinical Center in Bethesda, Maryland, runs clinical trials. Many other clinical trials take place ...

  6. Clinical Trials

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

  7. Clinical Trials

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    Full Text Available ... to-kol). This plan explains how the trial will work. The trial is led by a principal ... for the clinical trial. The protocol outlines what will be done during the clinical trial and why. ...

  8. Clinical Trials

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    Full Text Available ... and treatments that work best. How Clinical Trials Work If you take part in a clinical trial, ... kol). This plan explains how the trial will work. The trial is led by a principal investigator ( ...

  9. Study on managing EPICS database using ORACLE

    International Nuclear Information System (INIS)

    Liu Shu; Wang Chunhong; Zhao Jijiu

    2007-01-01

    EPICS is used as a development toolkit of BEPCII control system. The core of EPICS is a distributed database residing in front-end machines. The distributed database is usually created by tools such as VDCT and text editor in the host, then loaded to front-end target IOCs through the network. In BEPCII control system there are about 20,000 signals, which are distributed in more than 20 IOCs. All the databases are developed by device control engineers using VDCT or text editor. There's no uniform tools providing transparent management. The paper firstly presents the current status on EPICS database management issues in many labs. Secondly, it studies EPICS database and the interface between ORACLE and EPICS database. finally, it introduces the software development and application is BEPCII control system. (authors)

  10. Clinical Trials

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    Full Text Available ... give permission for their child to enroll. Also, children aged 7 and older often must agree (assent) to take part in clinical trials. Find a Clinical Trial If you're interested in learning more about, or taking part in, clinical trials, ...

  11. EPICS system: system structure and user interface

    International Nuclear Information System (INIS)

    West, R.E.; Bartlett, J.F.; Bobbitt, J.S.; Lahey, T.E.; Kramper, B.J.; MacKinnon, B.A.

    1984-02-01

    This paper present the user's view of and the general organization of the EPICS control system at Fermilab. Various subsystems of the EPICS control system are discussed. These include the user command language, software protection, the device database, remote computer interfaces, and several application utilities. This paper is related to two other papers on EPICS: an overview paper and a detailed implementation paper

  12. Three Object-Oriented enhancement for EPICS

    Science.gov (United States)

    Osberg, E. A.; Dohan, D. A.; Richter, R.; Biggs, R.; Chillara, K.; Wade, D.; Bossom, J.

    1994-12-01

    In line with our group's intention of producing software using, where possible, Object-Oriented methodologies and techniques in the development of RF control systems, we have undertaken three projects to enhance the EPICS software environment. Two of the projects involve interfaces to EPICs Channel Access from Object-Oriented languages. The third is an enhancement to the EPICS State Notation Language to better support the Shlaer-Mellor Object-Oriented Analysis and Design Methodology. This paper discusses the motivation, approaches, results and future directions of these three projects.

  13. EPICS IOC development on open source RTEMS RTOS

    International Nuclear Information System (INIS)

    Bharade, S.K.; Joshi, Gopal; Das, D.

    2015-01-01

    Modern control systems applications are often built on top of a real time operating system. At LEHIPA beamlines, open source control systems offer a modem solution for cost effectiveness and technical competence. The 'Experimental Physics and Industrial Control System' (EPICS) and the 'Real-Time Operating System for Multiprocessor Systems' (RTEMS) were chosen to develop the core control system. Presently, the EPICS/RTEMS/MVME5500 control system is implemented for RF Protection Interlock system and BPM. This paper shares an experience of building RTEMS for MVME5500, configuring and run EPICS for RTEMS-MVME5500 architecture. It further shows EPICS bench marking results using EPICS catime and hamesstest utilities for this architecture. (author)

  14. Clinical Trials

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    Full Text Available ... more information about eligibility criteria, go to "How Do Clinical Trials Work?" Some trials enroll people who ... for adults. For more information, go to "How Do Clinical Trials Protect Participants?" For more information about ...

  15. Clinical Trials

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    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. ...

  16. Clinical Trials

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    Full Text Available ... and treatments that work best. How Clinical Trials Work If you take part in a clinical trial, ... from a study at any time, for any reason. Also, during the trial, you have the right ...

  17. Clinical Trials

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    Full Text Available ... and treatments that work best. How Clinical Trials Work If you take part in a clinical trial, ... study? How might this trial affect my daily life? Will I have to be in the hospital? ...

  18. An EPICS IOC builder

    International Nuclear Information System (INIS)

    Abbott, M.G.; Cobb, T.

    2012-01-01

    An EPICS IOC (Input/Output Controller) is typically assembled from a number of standard components each with potentially quite complex hardware or software initialization procedures intermixed with a good deal of repetitive boiler-plate code. Assembling and maintaining a complex IOC can be a quite difficult and error prone process, particularly if the components are unfamiliar. The EPICS IOC builder is a Python library designed to automate the assembly of a complete IOC from a concise component level description. The dependencies and interactions between components as well as their detailed initialization procedures are automatically managed by the IOC builder through component description files maintained with the individual components. At Diamond Light Source we have a large library of components that can be assembled into EPICS IOCs. The IOC Builder is further finding increasing use in helping non-expert users to assemble an IOC without specialist knowledge. (authors)

  19. Clinical Trials

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

  20. Clinical Trials

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    Full Text Available ... these results are important because they advance medical knowledge and help improve patient care. Sponsorship and Funding ... All types of clinical trials contribute to medical knowledge and practice. Why Clinical Trials Are Important Clinical ...

  1. Clinical Trials

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    Full Text Available ... more screening tests to see which test produces the best results. Some companies and groups sponsor clinical trials that test the ... and Drug Administration (FDA) oversees these clinical trials. The NIH may partner with these companies or groups to help sponsor some trials. All ...

  2. Clinical Trials

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    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 ...

  3. DOE's Pollution Prevention Information Clearinghouse (EPIC)

    International Nuclear Information System (INIS)

    Otis, P.T.

    1994-05-01

    The US Department of Energy's (DOE's) Pollution Prevention Information Clearinghouse (EPIC) is a computer system intended for the exchange of pollution prevention information DOE-wide. EPIC is being developed as a distributed system that will allow access to other databases and applications. The first prototype of EPIC (Prototype I) was put on-line in January 1994. Prototype I contains information on EM-funded pollution prevention projects; relevant laws, regulations, guidance, and policy; facility and DOE contacts; and meetings and conferences. Prototype I also gives users access to the INEL Hazardous Solvent Substitution Data System (HSSDS) and to information contained on the US Environmental Protection Agency's (EPNS) Pollution Prevention Infbrmation Exchange System (PIES) as a test of the distributed system concept. An initial user group of about 35 is testing and providing feedback on Prototype I. Prototype II, with a Graphical User Interface (GUI), is planned for the end of CY94. This paper describes the current state of EPIC in terms of architecture, user interface, and information content. Plans for Prototype II and the final system are then discussed. The EPIC development effort is being coordinated with EPA and US Department of Defense (DoD) efforts to develop or upgrade their pollution prevention information exchange systems

  4. EPICS channel access using websocket

    International Nuclear Information System (INIS)

    Uchiyama, A.; Furukawa, K.; Higurashi, Y.

    2012-01-01

    Web technology is useful as a means of widely disseminating accelerator and beam status information. For this purpose, WebOPI was implemented by SNS as a web-based system using Ajax (asynchronous JavaScript and XML) with EPICS. On the other hand, it is often necessary to control the accelerator from different locations as well as the central control room during beam operation and maintenance. However, it is not realistic to replace the GUI-based operator interface (OPI) with a Web-based system using Ajax technology because of interactive performance issue. Therefore, as a next generation OPI over the web using EPICS Channel Access (CA), we developed a client system based on WebSocket, which is a new protocol provided by the Internet Engineering Task Force (IETF) for Web-based systems. WebSocket is a web technology that provides bidirectional, full-duplex communication channels over a single TCP connection. By utilizing Node.js and the WebSocket access library called Socket.IO, a WebSocket server was implemented. Node.js is a server-side JavaScript language built on the Google V8 JavaScript Engine. In order to construct the WebSocket server as an EPICS CA client, an add-on for Node.js was developed in C/C++ using the EPICS CA library, which is included in the EPICS base. As a result, for accelerator operation, Web-based client systems became available not only in the central control room but also with various types of equipment. (author)

  5. Understanding Clinical Trials

    Science.gov (United States)

    Watch these videos to learn about some basic aspects of cancer clinical trials such as the different phases of clinical trials, methods used to protect patient safety, and how the costs of clinical trials are covered.

  6. EPICS application source/release control

    International Nuclear Information System (INIS)

    Zieman, B.; Anderson, J.; Kraimer, M.

    1995-01-01

    This manual describes a set of Application Source/Release Control tools (appSR) that can be used to develop software for EPICS based control systems. The Application Source/Release Control System (appSR) has been unbundled from base EPICS and is now available as an EPICS extension. Due to this unbundling, two new directories must be added to a user's path (see section ''Environment'' on page 3 for more information) and a new command getapp must be issued after the getrel command to get a specific version of appSR (see section ''Creating The Initial Application System Area'' on page 7 for more information). It is now required that GNU make version 3.71 or later be used for makes instead of SUN make. Users should now type gmake instead of make

  7. Clinical Trials

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    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 ...

  8. Rapid application development by KEKB accelerator operators using EPICS/Python

    International Nuclear Information System (INIS)

    Tanaka, M.; Satoh, Y.; Kitabayashi, T.

    2004-01-01

    In the KEKB accelerator facility, the control system is constructed based on the framework of EPICS. By using EPICS/Python API, which is originated from KEK, we can develop an EPICS channel access application based on simple Python technology with only a few knowledge of EPICS channel access protocols. The operator's new tuning ideas are quickly implemented to the control system. In this paper, we introduce the EPICS/Python API and report the effectiveness of rapid application development by the KEKB operators using the API. (author)

  9. Clinical Trials

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    Full Text Available ... benefits of lowering high blood pressure in the elderly outweighed the risks. Other examples of clinical trials ... child to enroll. Also, children aged 7 and older often must agree (assent) to ... as clinical trials for adults. For more information, go to "How Do Clinical ...

  10. Clinical Trials

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

  11. Clinical Trials

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

  12. EPICS and its role in data acquisition and beamline control

    International Nuclear Information System (INIS)

    Mooney, T. M.; Arnold, N. D.; Boucher, E.; Cha, B. K.; Goetze, K. A.; Kraimer, M. R.; Rivers, M. L.; Sluiter, R. L.; Sullivan, J. P.; Wallis, D. B.

    1999-01-01

    Beamline-control and data-acquisition software based on EPICS (a tool kit for building distributed control systems) has been running on many Advanced Photon Source beamlines for several years. EPICS itself, the collaborative software-development effort surrounding it, and EPICS-based beamline software have been described previously in general terms. This talk will review and update that material, focusing on the role EPICS core software plays in beamline applications and on the effects of a few defining characteristics of EPICS on the beamline software we have developed with it

  13. Qt based GUI system for EPICS control systems

    International Nuclear Information System (INIS)

    Rhyder, A.; Fernandes, R.N.; Starritt, A.

    2012-01-01

    The Qt-based GUI system developed at the Australian Synchrotron for use on EPICS control systems has recently been enhanced to including support for imaging, plotting, user login, logging and configuration recipes. Plans are also being made to broaden its appeal within the wider EPICS community by expanding the range of development options and adding support for EPICS V4. Current features include graphical and non-graphical application development as well as simple 'code-free' GUI design. Additional features will allow developers to let the GUI system handle its own data using Qt-based EPICS-aware classes or, as an alternative, use other control systems data such as PSI's CAFE. (author)

  14. Integrating commercial and legacy systems with EPICS

    International Nuclear Information System (INIS)

    Hill, J.O.; Kasemir, K.U.

    1997-01-01

    The Experimental Physics and Industrial Control System (EPICS) is a software toolkit, developed by a worldwide collaboration, which significantly reduces the level of effort required to implement a new control system. Recent developments now also significantly reduce the level of effort required to integrate commercial, legacy and/or site-authored control systems with EPICS. This paper will illustrate with an example both the level and type of effort required to use EPICS with other control system components as well as the benefits that may arise

  15. Epic Allies, a Gamified Mobile Phone App to Improve Engagement in Care, Antiretroviral Uptake, and Adherence Among Young Men Who Have Sex With Men and Young Transgender Women Who Have Sex With Men: Protocol for a Randomized Controlled Trial.

    Science.gov (United States)

    LeGrand, Sara; Muessig, Kathryn E; Platt, Alyssa; Soni, Karina; Egger, Joseph R; Nwoko, Nkechinyere; McNulty, Tobias; Hightow-Weidman, Lisa B

    2018-04-05

    primary outcome measure is viral suppression. Secondary outcome measures include engagement in care, ART uptake, ART adherence, and psychosocial barriers to engagement in care and ART adherence, including psychological distress, stigma, and social support. Baseline enrollment began in September 2015 and was completed in September 2016 (n=146), and assessment of intervention outcomes continued through August 2017. Results for primary and secondary outcome measures are expected to be reported in ClinicalTrials.gov by April 30, 2018. If successful, Epic Allies will represent a novel adherence intervention for a group disproportionately impacted by HIV in the United States. Adherent patients would require less frequent clinic visits and experience fewer HIV-related secondary infections, thereby reducing health care costs and HIV transmission. Epic Allies could easily be expanded and adopted for use among larger populations of YMSM and YTWSM, other HIV-positive populations, and for those diagnosed with other chronic diseases such as diabetes and hypertension. ClinicalTrials.gov NCT02782130; https://clinicaltrials.gov/ct2/show/NCT02782130 (Archived by Webcite at http://www.webcitation.org/6yGODyerk). ©Sara LeGrand, Kathryn E Muessig, Alyssa Platt, Karina Soni, Joseph R Egger, Nkechinyere Nwoko, Tobias McNulty, Lisa B Hightow-Weidman. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 05.04.2018.

  16. Clinical Trials

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    Full Text Available ... Some companies and groups sponsor clinical trials that test the safety of products, such as medicines, and how well they work. The U.S. Food and Drug Administration (FDA) oversees these clinical trials. ...

  17. Clinical Trials

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    Full Text Available ... medical strategy, treatment, or device is safe and effective for humans. What Are Clinical Trials? Clinical trials ... medical strategy, treatment, or device is safe and effective for humans. These studies also may show which ...

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    Full Text Available ... needed. For safety purposes, clinical trials start with small groups of patients to find out whether a ... phase I clinical trials test new treatments in small groups of people for safety and side effects. ...

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    Full Text Available ... and treatments that work best. How Clinical Trials Work If you take part in a clinical trial, ... care providers might be part of your treatment team. They will monitor your health closely. You may ...

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    Full Text Available ... at the smallest dose and for the shortest time possible. Clinical trials, like the two described above, ... in a clinical trial, find out ahead of time about costs and coverage. You should learn about ...

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    Full Text Available ... Events About NHLBI About NHLBI Home Mission and Strategic Vision Leadership Scientific Divisions Operations and Administration Advisory ... a Clinical Trial If you're interested in learning more about, or taking part in, clinical trials, ...

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

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    Full Text Available ... sponsor clinical trials. Many other groups, companies, and organizations also sponsor clinical trials. Examples include Government Agencies, ... and Veterans Affairs; private companies; universities; and nonprofit organizations. NIH Institutes and Centers (including the NHLBI) usually ...

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    Full Text Available ... and doctors' offices around the country. Benefits and Risks Possible Benefits Taking part in a clinical trial ... volunteer because they want to help others. Possible Risks Clinical trials do have risks and some downsides, ...

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    Full Text Available ... organizations also sponsor clinical trials. Examples include Government Agencies, such as the U.S. Departments of Defense and ... to Expect During a clinical trial, doctors, nurses, social workers, and other health care providers might be ...

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    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 ...

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  3. Expanded HIV pre-exposure prophylaxis (PrEP) implementation in communities in New South Wales, Australia (EPIC-NSW): design of an open label, single arm implementation trial.

    Science.gov (United States)

    Zablotska, Iryna B; Selvey, Christine; Guy, Rebecca; Price, Karen; Holden, Jo; Schmidt, Heather-Marie; McNulty, Anna; Smith, David; Jin, Fengyi; Amin, Janaki; Cooper, David A; Grulich, Andrew E

    2018-02-02

    The New South Wales (NSW) HIV Strategy 2016-2020 aims for the virtual elimination of HIV transmission in NSW, Australia, by 2020. Despite high and increasing levels of HIV testing and treatment since 2012, the annual number of HIV diagnoses in NSW has remained generally unchanged. Pre-exposure prophylaxis (PrEP) is highly effective in preventing HIV infection among gay and bisexual men (GBM) when taken appropriately. However, there have been no population-level studies that evaluate the impact of rapid PrEP scale-up in high-risk GBM. Expanded PrEP Implementation in Communities in NSW (EPIC-NSW) is a population-level evaluation of the rapid, targeted roll-out of PrEP to high-risk individuals. EPIC-NSW, is an open-label, single-arm, multi-centre prospective observational study of PrEP implementation and impact. Over 20 public and private clinics across urban and regional areas in NSW have participated in the rapid roll-out of PrEP, supported by strong community mobilization and PrEP promotion. The study began on 1 March 2016, aiming to enroll at least 3700 HIV negative people at high risk of HIV. This estimate took into consideration criteria for PrEP prescription in people at high risk for acquiring HIV as defined in the NSW PrEP guidelines. Study participants receive once daily co-formulated tenofovir disoproxil fumarate and emtricitabine (TDF/FTC) and are followed for up to 24 months. Follow-up includes: testing for HIV at 1 month, HIV and other sexually transmissible infections three-monthly, HCV annually and monitoring of renal function six-monthly. Optional online behavioural surveys are conducted quarterly. The co-primary endpoints are (i) HIV diagnoses and incidence in the cohort and (ii) HIV diagnoses in NSW. EPIC-NSW is a population-based PrEP implementation trial which targets the entire estimated population of GBM at high risk for HIV infection in NSW. It will provide a unique opportunity to evaluate the population impact of PrEP on a concentrated HIV

  4. Clinical Trials

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    Full Text Available ... the clinical trial you take part in, the information gathered can help others and add to scientific knowledge. People who take part in clinical trials are vital to the process of improving medical care. Many people volunteer because ...

  5. Conducting clinical trials in Singapore.

    Science.gov (United States)

    Woo, K T

    1999-04-01

    All clinical trials in Singapore will now have to conform to the Medicines (Clinical Trials) Amended Regulations 1998 and the Singapore Good Clinical Practice (GCP) Guidelines 1998. The Medical Clinical Research Committee (MCRC) has been established to oversee the conduct of clinical drug trials in Singapore and together with the legislations in place, these will ensure that clinical trials conducted in Singapore are properly controlled and the well-being of trial subjects are safe guarded. All clinical drug trials require a Clinical Trial Certificate from the MCRC before the trial can proceed. The hospital ethics committee (EC) vets the application for a trial certificate before it is sent to MCRC. The drug company sponsoring the trial has to indemnify the trial investigators and the hospital for negligence arising from the trial. The MCRC, apart from ensuring the safety of trial subjects, has to provide continuing review of the clinical trial and monitors adverse events in the course of the trial. The EC will conduct continuing review of clinical trials. When a non-drug clinical trial is carried out, the EC will ensure that the proposed protocol addresses ethical concerns and meets regulatory requirements for such trials. There is great potential for pharmaceutical Research & Development (R&D) in Singapore. We must develop our skills and infrastructure in clinical trials to enable Singapore to be a regional hub for R&D of drugs in Asia.

  6. Clinical Trials

    Medline Plus

    Full Text Available ... a Clinical Trial If you're interested in learning more about, or taking part in, clinical trials, talk with your doctor. He or she may know about studies going on in your area. You can visit the following website to learn more about ...

  7. Clinical Trials

    Medline Plus

    Full Text Available ... Expect During a clinical trial, doctors, nurses, social workers, and other health care providers might be part of your treatment ... phase II clinical trials. The risk of side effects might be even greater for ... treatments. Health insurance and health care providers don't always ...

  8. Monitor and Control for PEFP System using EPICS

    International Nuclear Information System (INIS)

    Choi, Hyun Mi; Hong, I. S.; Song, Y. G.; Cho, Y. S.

    2005-01-01

    The construction of PEFP project whose final objective is to build 100 Mev proton accelerator started in 2002 and expected to finish in 2012. In 2005, we have performed 20mA proton beam of 20Mev. For developing the control systems of the 20Mev accelerator as well as 100 Mev accelerator, we chose EPICS(Experimental Physics and Industrial Control System) as the most suitable tool. We have studied EPICS applications for various situation and as the application we developed vacuum control system using EPICS base3.14.4 as the core software and EPICS extensions (e.g., EDM(Extensible Display Manager), MEDM(Motif Editor and Display Manager) etc.) as the user interface. There are a number of projects using EPICS for a broad spectrum of applications. EPICS began as a collaboration between Argonne National Laboratory and Los Alamos National Laboratory in 1991, building on work that was initially done at the ground test Accelerator. It is now running on accelerators that have as many as 180 distributed front-end controllers and control rooms with 20 consoles and a gateway to make system parameters available to offices, web site, and other remote control stations. It is also used at single controller and one workstation systems. We use the EPICS tool kit as a foundation of the control system. We developed a vacuum monitor, RFQ, DTL Turbo pump control system for use Ethernet Multi Serial Deice Severs on PEFP control system. The control system now shows stable and reliable characteristics enough to meet our control requirement. However, the control system is continuously being upgraded to accommodate additional control requirements such as vacuum device control

  9. Clinical Trials

    Medline Plus

    Full Text Available ... products, such as medicines, and how well they work. The U.S. Food and Drug Administration (FDA) oversees these clinical trials. ... cancer also increased. As a result, the U.S. Food and Drug Administration now recommends never using HT ... Clinical Trials Work If you take ...

  10. The rebirth of the epic from the Nietzsche's Philosophy

    Directory of Open Access Journals (Sweden)

    Reza Samim

    2016-12-01

    Full Text Available his philosophy with Iranian mysticism. Such identification is fundamentally flawed and contradicts Nietzsche's ontological principles and moral values. Some of the Iranian commentators, expert in Nietzsche's philosophy, identified Nietzsche's thought is pregnant from the epic universal values, not the mystical patterns. Understanding of Nietzsche's Philosophy is possible with the help of Shahnameh and Iliad not mysticism. The reason of this fundamental error lies in the fact that these Iranian commentators fail to distinguish the subtle differences between mysticism and epic, and this failure, has led to their mixing Nietzsche's thought with the Iranian mysticism. Epic and mysticism are related in the differences not the similarities. Although there could be some similarities between the mystical worldview and that of epic, they are merely outward and superficial. In effect, in the matter of epistemic, moral and ontological principles, epic contradicts mysticism. At the best, mysticism can be considered to be the negative correspondence of epic and called “Negative Epic”. Nietzsche's thought has been affected to a greater extent by the Greek culture than and prior to the Iranian traditions. Nietzche's symbolic recourse to Zoroaster cannot be a cogent basis for these commentators' claim. Moreover, Nietzche's grasp of Zoroastrian worldview is so much blurred and incomplete. He appreciates the Greek culture not the Iranian traditions. Therefore, autonomy, voluntarism, appreciation of life and denunciation of passivity are the set of values and principles associating Nietzsche's philosophy with epic. These are exactly the principles disregarded and even denied in mystical thought. In other words, Nietzsche's philosophy can be considered the rebirth of the epic in the sphere of philosophical thought.

  11. Clinical Trials

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    Full Text Available ... from other clinical trials show what doesn't work or may cause harm. For example, the NHLBI Women's Health Initiative ... safe a treatment is or how well it works. Children (aged 18 and younger) get ... legal consent for their child to take part in a clinical trial. When ...

  12. Clinical Trials

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    Full Text Available ... to Expect During a clinical trial, doctors, nurses, social workers, and other health care providers might be part of your treatment ... clinical trials are vital to the process of improving medical care. Many people ... participants, it may not work for you. A new treatment may have side ...

  13. Clinical Trials

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    Full Text Available ... you agree to take part in the trial. Talk with your doctor about specific trials you're ... part in a clinical trial is your decision. Talk with your doctor about all of your treatment ...

  14. Clinical Trials

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    Full Text Available ... any clinical trial before you agree to take part in the trial. Talk with your doctor about specific trials you're interested in. For a list of questions to ask your doctor and the ...

  15. Managing clinical trials

    Directory of Open Access Journals (Sweden)

    Kenyon Sara

    2010-07-01

    Full Text Available Abstract Managing clinical trials, of whatever size and complexity, requires efficient trial management. Trials fail because tried and tested systems handed down through apprenticeships have not been documented, evaluated or published to guide new trialists starting out in this important field. For the past three decades, trialists have invented and reinvented the trial management wheel. We suggest that to improve the successful, timely delivery of important clinical trials for patient benefit, it is time to produce standard trial management guidelines and develop robust methods of evaluation.

  16. EPICS architecture

    International Nuclear Information System (INIS)

    Dalesio, L.R.; Kozubal, A.J.; Kraimer, M.R.

    1992-01-01

    The Experimental Physics and Industrial Control System (EPICS) provides control and data acquisition for the experimental physics community. Because the capabilities required by the experimental physics community for control were not available through industry, we began the design and implementation of EPICS. It is a distributed process control system built on a software communication bus. The functional subsystems, which provide data acquisition, supervisory control, closed loop control, archiving, and alarm management, greatly reduce the need for programming. Sequential control is provided through a sequential control language, allowing the implementer to express state diagrams easily. Data analysis of the archived data is provided through an interactive tool. The timing system provides distributed synchronization for control and time stamped data for data correlation across nodes in the network. The system is scalable from a single test station with a low channel count to a large distributed network with thousands of channels. The functions provided to the physics applications have proven helpful to the experiments while greatly reducing the time to deliver controls. (author)

  17. Clinical implications of JUPITER in a contemporary European population: the EPIC-Norfolk prospective population study.

    Science.gov (United States)

    Sondermeijer, Brigitte M; Boekholdt, S Matthijs; Rana, Jamal S; Kastelein, John J P; Wareham, Nicholas J; Khaw, Kay-Tee

    2013-05-01

    Justification for the Use of statins in Prevention: an Intervention Trial Evaluating Rosuvastatin (JUPITER) has raised several points of debate. We quantified the proportion of individuals meeting the JUPITER criteria, determined their risk profile, and their risk of coronary heart disease (CHD) events during a long-term follow-up in a contemporary European cohort. A total of 25 639 participants aged between 45 and 79 years were followed for 11.4 ± 2.8 years in EPIC-Norfolk population cohort. A total of 8397 individuals with complete data available were considered potentially eligible for primary prevention. A total of 846 (10.1%) individuals fulfilled the JUPITER criteria [low-density lipoprotein cholesterol-C (LDL-C) JUPITER criteria had significantly higher CHD risk compared with those with LDL-C ≥ 3.4 mmol/L and C-reactive protein JUPITER criteria. In this European cohort, JUPITER-eligible individuals had significantly higher event rates compared with those with LDL-C JUPITER criteria qualified almost one-fifth of the population for statin therapy that otherwise would not have qualified based on SCORE or ATP III criteria.

  18. Enlisted Personnel Individualized Career System (EPICS) Test and Evaluation

    Science.gov (United States)

    1984-01-01

    The EPICS program, which was developed using an integrated personnel systems approach ( IPSA ), delays formal school training until after personnel have...received shipboard on-job training complemented by job performance aids (3PAs). Early phases of the program, which involved developing the IPSA EPICS...detailed description of the conception and development of the EPICS IPSA model, the execution of the front-end job design analyses, 3PA and instructional

  19. Fundamentals of clinical trials

    CERN Document Server

    Friedman, Lawrence M; DeMets, David L; Reboussin, David M; Granger, Christopher B

    2015-01-01

    This is the fifth edition of a very successful textbook on clinical trials methodology, written by recognized leaders who have long and extensive experience in all areas of clinical trials. The three authors of the first four editions have been joined by two others who add great expertise.  Most chapters have been revised considerably from the fourth edition.  A chapter on regulatory issues has been included and the chapter on data monitoring has been split into two and expanded.  Many contemporary clinical trial examples have been added.  There is much new material on adverse events, adherence, issues in analysis, electronic data, data sharing, and international trials.  This book is intended for the clinical researcher who is interested in designing a clinical trial and developing a protocol. It is also of value to researchers and practitioners who must critically evaluate the literature of published clinical trials and assess the merits of each trial and the implications for the care and treatment of ...

  20. Operational experience from a large EPICS-based accelerator facility

    International Nuclear Information System (INIS)

    Ciarlette, D.J.; Gerig, R.

    1995-01-01

    The Advanced Photon Source (APS) at Argonne National Laboratory is a third-generation x-ray light source which uses the Experimental Physics and Industrial Control System (EPICS) to operate its linear accelerator, positron accumulator ring, booster synchrotron, and storage ring equipment. EPICS has been used at the APS since the beginning of installation and commissioning. Currently, EPICS controls approximately 100 VME crates containing over 100,000 process variables. With this complexity, the APS has had to review some of the methods originally employed and make changes as necessary. In addition, due to commissioning and operational needs, higher-level operator software needed to be created. EPICS has been flexible enough to allow this

  1. On the Issue of Origin of the Yakut Epic Olonkho

    Directory of Open Access Journals (Sweden)

    Vasiliy Nikolayevich Ivanov

    2018-03-01

    Full Text Available The issue on the origin of the Yakut heroic epic Olonkho was covered in works in history and ethnography of the Yakuts back in the 19th century, for instance, in the famous monograph Yakuts. Experience of ethnographic research by a Polish exile V.L. Seroshevskiy (1896. Since that time, this issue was interesting for many, but no special monograph research has been done yet. Currently, the issue of Olonkho origin is gaining special scientific and general cultural significance, as on November 25, 2005 the Yakut heroic epic Olonkho according to the historical decision of UNESCO was granted the high status “Masterpiece of oral and non-material heritage of humanity”. The Yakut epic is a part of the multicomponent epic creative work of the Turkic nations but it was the only one to get such a high international recognition. This paper aims to revive the scientific interest to the issue of the Yakut epic’s genesis. To date, some rich source-related and historiographical material has been accumulated for broader generalizations – the main point is that the Yakut epic is becoming an important object of comparative historical analysis of the origin of all Turkic epics. The thing is that epic researchers admit that almost a thousand years of existence isolated from the whole Turkic world in the North-East of Asia kept many archaic features of the epics of the ancient ancestors – natives of Central Asia and Southern Siberia. It became clear that Olonkho origin is organically linked with the ethnic history of its nation.The paper follows this comprehensive process reflected in works by archeologists, ethnographers, historians and linguists. Their latest achievements are impressive, bringing a lot of novelty into the conventional views of origins and development of the Yakut epic. The paper attempts to specify that novelty and rationalize the idea that time has come to introduce that novelty into science to solve the long-standing issue of origin of

  2. Clinical trial methodology

    National Research Council Canada - National Science Library

    Peace, Karl E; Chen, Ding-Geng

    2011-01-01

    "Now viewed as its own scientific discipline, clinical trial methodology encompasses the methods required for the protection of participants in a clinical trial and the methods necessary to provide...

  3. 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.

  4. The EPICS process variable Gateway Version 2

    International Nuclear Information System (INIS)

    Evans, K.

    2005-01-01

    The EPICS Process Variable Gateway is both a Channel Access Server and Channel Access Client that provides a means for many clients, typically on different subnets, to access a process variable while making only one connection to the server that owns the process variable. It also provides additional access security beyond that implemented on the server. It thus protects critical servers while providing suitably restricted access to needed process variables. The original version of the Gateway worked with EPICS Base 3.13 but required a special version, since the changes necessary for its operation were never incorporated into EPICS Base. Version 2 works with any standard EPICS Base 3.14.6 or later and has many improvements in both performance and features over the older version. The Gateway is now used at many institutions and has become a stable, high-performance application. It is capable of handling tens of thousands of process variables with hundreds of thousands of events per second. It has run for over three months in a production environment without having to be restarted. It has many internal process variables that can be used to monitor its state using standard EPICS client tools, such as MEDM and StripTool. Other internal process variables can be used to stop the Gateway, make several kinds of reports, or change the access security without stopping the Gateway. It can even be started on remote workstations from MEDM by using a Secure Shell script. This paper will describe the new Gateway and how it is used. The Gateway is both a server (like an EPICS Input/Output Controller (IOC)) and a client (like the EPICS Motif Editor and Display Manager (MEDM), StripTool, and others). Clients connect to the server side, and the client side connects to IOCs and other servers, possibly other Gateways. See Fig. 1. There are perhaps three principal reasons for using the Gateway: (1) it allows many clients to access a process variable while making only one connection to

  5. Sexual Function After Stereotactic Body Radiotherapy for Prostate Cancer: Results of a Prospective Clinical Trial

    International Nuclear Information System (INIS)

    Wiegner, Ellen A.; King, Christopher R.

    2010-01-01

    Purpose: To study the sexual quality of life for prostate cancer patients after stereotactic body radiotherapy (SBRT). Methods and Materials: Using the Expanded Prostate Cancer Index Composite (EPIC)-validated quality-of-life questionnaire, the sexual function of 32 consecutive patients who received prostate SBRT in a prospective Phase II clinical trial were analyzed at baseline, and at median times of 4, 12, 20, and 50 months after treatment. SBRT consisted of 36.25 Gy in five fractions of 7.25 Gy using the Cyberknife. No androgen deprivation therapy was given. The use of erectile dysfunction (ED) medications was monitored. A comprehensive literature review for radiotherapy-alone modalities based on patient self-reported questionnaires served as historical comparison. Results: Median age at treatment was 67.5 years, and median follow-up was 35.5 months (minimum 12 months). The mean EPIC sexual domain summary score, sexual function score, and sexual bother score decreased by 45%, 49%, and 25% respectively at 50 months follow-up. These differences reached clinical relevance by 20 months after treatment. Baseline ED rate was 38% and increased to 71% after treatment (p = 0.024). Use of ED medications was 3% at baseline and progressed to 25%. For patients aged <70 years at follow-up, 60% maintained satisfactory erectile function after treatment compared with only 12% aged ≥70 years (p = 0.008). Penile bulb dose was not associated with ED. Conclusions: The rates of ED after treatment appear comparable to those reported for other modalities of radiotherapy. Given the modest size of this study and the uncertainties in the physiology of radiotherapy-related ED, these results merit further investigations.

  6. The Cosmopolitan Epics of 2004: A Case Study

    Directory of Open Access Journals (Sweden)

    Assoc. Prof. Saverio Giovacchini

    2011-01-01

    Full Text Available In 2004 Hollywood produced three purportedly blockbuster epic films:Troy, King Arthur and Alexander. Many critics suggested a direct linkbetween the 1950s “sword and sandal” epic and this new crop of movies.Similarities between the two cycles certainly exist but in this essay I want to emphasize a crucial difference between the contemporary,cosmopolitan, epic and the previous, more nation-bound, 1950s cycle.Rather than being in tune with key elements of American foreign policy, the new cycle of “sword and sandal” films offers a somber assessment of American imperial adventures. I shall contend, in fact, that the new crop of epic films had to choose between two generic conventions that are, at present, not compatible. On the one hand, epic films had traditionally been the bearers of the foreign policy vision of the country that produced them. On the other, their inflated budgets made them dependent on an international market. Deeply aware of a globalized and rising opposition to US foreign policy and of the fact that foreign box office now exceeds the domestic take of a blockbuster, it may be no wonder that the makers of these films chose to craft them into citizens of the world.

  7. The Philippine Epics and Ballads Multimedia Archive

    Directory of Open Access Journals (Sweden)

    Nicole Revel

    2013-10-01

    Full Text Available This essay offers an introduction to the Philippine Epics and Ballads Archive. This collection is a joint endeavor between singers, scholars, knowledgeable local persons, and technical assistants. This archive exemplifies a part of the cultural heritage among 15 national cultural communities and their respective languages. A multi-media eCompanion offers an interactive version of a Palawan epic song.

  8. EPICS - MDSplus integration in the ITER Neutral Beam Test Facility

    International Nuclear Information System (INIS)

    Luchetta, Adriano; Manduchi, Gabriele; Barbalace, Antonio; Soppelsa, Anton; Taliercio, Cesare

    2011-01-01

    SPIDER, the ITER-size ion-source test bed in the ITER Neutral Beam Test Facility, is a fusion device requiring a complex central system to provide control and data acquisition, referred to as CODAS. The CODAS software architecture will rely on EPICS and MDSplus, two open-source, collaborative software frameworks, targeted at control and data acquisition, respectively. EPICS has been selected as ITER CODAC middleware and, as the final deliverable of the Neutral Beam Test Facility is the procurement of the ITER Heating Neutral Beam Injector, we decided to adopt this ITER technology. MDSplus is a software package for data management, supporting advanced concepts, such as platform and underlying hardware independence, self description data, and data driven model. The combined use of EPICS and MDSplus is not new in fusion, but their level of integration will be new in SPIDER, achieved by a more refined data access layer. The paper presents the integration software to use effectively EPICS and MDSplus, including the definition of appropriate EPICS records to interact with MDSplus. The MDSplus and EPICS archive concepts are also compared on the basis of performance tests and data streaming is investigated by ad-hoc measurements.

  9. Clinical Trials

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    Full Text Available ... well they work. The U.S. Food and Drug Administration (FDA) oversees these clinical trials. The NIH may partner with these companies or groups to help sponsor some trials. All ...

  10. Web services interface to EPICS channel access

    Institute of Scientific and Technical Information of China (English)

    DUAN Lei; SHEN Liren

    2008-01-01

    Web services is used in Experimental Physics and Industrial Control System (EPICS). Combined with EPICS Channel Access protocol, Web services' high usability, platform independence and language independence can be used to design a fully transparent and uniform software interface layer, which helps us complete channel data acquisition, modification and monitoring functions. This software interface layer, a cross-platform of cross-language,has good interopcrability and reusability.

  11. Web services interface to EPICS channel access

    International Nuclear Information System (INIS)

    Duan Lei; Shen Liren

    2008-01-01

    Web services is used in Experimental Physics and Industrial Control System (EPICS). Combined with EPICS Channel Access protocol, Web services high usability, platform independence and language independence can be used to design a fully transparent and uniform software interface layer, which helps us complete channel data acquisition, modification and monitoring functions. This software interface layer, a cross-platform of cross-language, has good interoperability and reusability. (authors)

  12. A Cloud Top Pressure Algorithm for DSCOVR-EPIC

    Science.gov (United States)

    Min, Q.; Morgan, E. C.; Yang, Y.; Marshak, A.; Davis, A. B.

    2017-12-01

    The Earth Polychromatic Imaging Camera (EPIC) sensor on the Deep Space Climate Observatory (DSCOVR) satellite presents unique opportunities to derive cloud properties of the entire daytime Earth. In particular, the Oxygen A- and B-band and corresponding reference channels provide cloud top pressure information. In order to address the in-cloud penetration depth issue—and ensuing retrieval bias—a comprehensive sensitivity study has been conducted to simulate satellite-observed radiances for a wide variety of cloud structures and optical properties. Based on this sensitivity study, a cloud top pressure algorithm for DSCOVR-EPIC has been developed. Further, the algorithm has been applied to EPIC measurements.

  13. Perfusion Electronic Record Documentation Using Epic Systems Software.

    Science.gov (United States)

    Riley, Jeffrey B; Justison, George A

    2015-12-01

    The authors comment on Steffens and Gunser's article describing the University of Wisconsin adoption of the Epic anesthesia record to include perfusion information from the cardiopulmonary bypass patient experience. We highlight the current-day lessons and the valuable quality and safety principles the Wisconsin-Epic model anesthesia-perfusion record provides.

  14. Simulation using Xorbit with EPICS

    International Nuclear Information System (INIS)

    Evans, K. Jr.

    1995-01-01

    The accelerator code Xorbit has an interface to the Experimental Physics and Industrial Control System (EPICS). This means that machine data such as magnet settings can be sent to Xorbit via EPICS, and the resulting orbit parameters such as beta functions, etc., can be calculated. In addition, Xorbit can be made to simulate the real machine, whether the latter is running or not. To accomplish this for the APS, there is a database of process variables in an IOC corresponding to each APS ring and beamline. These process variables are very similar to the real process variables that read and set power supplies and read monitors, except that when a setting is changed, Xorbit is notified via a callback, calculates a new orbit, and outputs the appropriate readbacks to the database. By attaching the string ''Xorbit:'' to a control name the control system will respond to the simulation rather than the real system. This allows the testing of control algorithms, orbit diagnostics, and many other components of the control system (as well as EPICS itself). It is fast enough to be visually similar to accessing the real system

  15. Exon-primed intron-crossing (EPIC markers for non-model teleost fishes

    Directory of Open Access Journals (Sweden)

    Riethoven Jean-Jack M

    2010-03-01

    Full Text Available Abstract Background Exon-primed intron-crossing (EPIC markers have three advantages over anonymous genomic sequences in studying evolution of natural populations. First, the universal primers designed in exon regions can be applied across a broad taxonomic range. Second, the homology of EPIC-amplified sequences can be easily determined by comparing either their exon or intron portion depending on the genetic distance between the taxa. Third, having both the exon and intron fragments could help in examining genetic variation at the intraspecific and interspecific level simultaneously, particularly helpful when studying species complex. However, the paucity of EPIC markers has hindered multilocus studies using nuclear gene sequences, particularly in teleost fishes. Results We introduce a bioinformatics pipeline for developing EPIC markers by comparing the whole genome sequences between two or more species. By applying this approach on five teleost fishes whose genomes were available in the Ensembl database http://www.ensembl.org, we identified 210 EPIC markers that have single-copy and conserved exon regions with identity greater than 85% among the five teleost fishes. We tested 12 randomly chosen EPIC markers in nine teleost species having a wide phylogenetic range. The success rate of amplifying and sequencing those markers varied from 44% to 100% in different species. We analyzed the exon sequences of the 12 EPIC markers from 13 teleosts. The resulting phylogeny contains many traditionally well-supported clades, indicating the usefulness of the exon portion of EPIC markers in reconstructing species phylogeny, in addition to the value of the intron portion of EPIC markers in interrogating the population history. Conclusions This study illustrated an effective approach to develop EPIC markers in a taxonomic group, where two or more genome sequences are available. The markers identified could be amplified across a broad taxonomic range of teleost

  16. An object oriented framework of EPICS for MicroTCA based control system

    International Nuclear Information System (INIS)

    Geng, Z.

    2012-01-01

    EPICS (Experimental Physics and Industrial Control System) is a distributed control system platform which has been widely used for large scientific devices control like particle accelerators and fusion plant. EPICS has introduced object oriented (C ++ ) interfaces to most of the core services. But the major part of EPICS, the run-time database, only provides C interfaces, which is hard to involve the EPICS record concerned data and routines in the object oriented architecture of the software. This paper presents an object oriented framework which contains some abstract classes to encapsulate the EPICS record concerned data and routines in C ++ classes so that full OOA (Objected Oriented Analysis) and OOD (Object Oriented Design) methodologies can be used for EPICS IOC design. We also present a dynamic device management scheme for the hot swap capability of the MicroTCA based control system. (authors)

  17. 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 ...

  18. 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, ...

  19. Clinical Trials

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    Full Text Available ... healthy people to test new approaches to prevention, diagnosis, or screening. In the past, clinical trial participants ... DSMBs for large trials comparing alternative strategies for diagnosis or treatment. In addition, the NIH requires DSMBs ...

  20. Clinical Trials

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    Full Text Available ... or strategies work best for certain illnesses or groups of people. Some clinical trials show a positive result. For example, the National Heart, Lung, and Blood Institute (NHLBI) sponsored a trial of two different ...

  1. Clinical Trials

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    Full Text Available ... including the NHLBI) usually sponsor trials that test principles or strategies. For example, one NHLBI study explored ... risks. Other examples of clinical trials that test principles or strategies include studies that explore whether surgery ...

  2. Clinical Trials

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    Full Text Available ... the same scientific safeguards as clinical trials for adults. For more information, go to "How Do Clinical ... based on what is known to work in adults. To improve clinical care of children, more studies ...

  3. Clinical Trials

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    Full Text Available ... you to explore NIH Clinical Center for patient recruitment and clinical trial information. For more information, please email the NIH Clinical Center Office of Patient Recruitment at cc-prpl@cc.nih.gov or call ...

  4. A Consistent EPIC Visible Channel Calibration Using VIIRS and MODIS as a Reference.

    Science.gov (United States)

    Haney, C.; Doelling, D. R.; Minnis, P.; Bhatt, R.; Scarino, B. R.; Gopalan, A.

    2017-12-01

    The Earth Polychromatic Imaging Camera (EPIC) aboard the Deep Space Climate Observatory (DSCOVR) satellite constantly images the sunlit disk of Earth from the Lagrange-1 (L1) point in 10 spectral channels spanning the UV, VIS, and NIR spectrums. Recently, the DSCOVR EPIC team has publicly released version 2 dataset, which has implemented improved navigation, stray-light correction, and flat-fielding of the CCD array. The EPIC 2-year data record must be well-calibrated for consistent cloud, aerosol, trace gas, land use and other retrievals. Because EPIC lacks onboard calibrators, the observations made by EPIC channels must be calibrated vicariously using the coincident measurements from radiometrically stable instruments that have onboard calibration systems. MODIS and VIIRS are best-suited instruments for this task as they contain similar spectral bands that are well-calibrated onboard using solar diffusers and lunar tracking. We have previously calibrated the EPIC version 1 dataset by using EPIC and VIIRS angularly matched radiance pairs over both all-sky ocean and deep convective clouds (DCC). We noted that the EPIC image required navigations adjustments, and that the EPIC stray-light correction provided an offset term closer to zero based on the linear regression of the EPIC and VIIRS ray-matched radiance pairs. We will evaluate the EPIC version 2 navigation and stray-light improvements using the same techniques. In addition, we will monitor the EPIC channel calibration over the two years for any temporal degradation or anomalous behavior. These two calibration methods will be further validated using desert and DCC invariant Earth targets. The radiometric characterization of the selected invariant targets is performed using multiple years of MODIS and VIIRS measurements. Results of these studies will be shown at the conference.

  5. An analysis of registered clinical trials in otolaryngology from 2007 to 2010: ClinicalTrials.gov.

    Science.gov (United States)

    Witsell, David L; Schulz, Kristine A; Lee, Walter T; Chiswell, Karen

    2013-11-01

    To describe the conditions studied, interventions used, study characteristics, and funding sources of otolaryngology clinical trials from the ClinicalTrials.gov database; compare this otolaryngology cohort of interventional studies to clinical visits in a health care system; and assess agreement between clinical trials and clinical activity. Database analysis. Trial registration data downloaded from ClinicalTrials.gov and administrative data from the Duke University Medical Center from October 1, 2007 to September 27, 2010. Data extraction from ClinicalTrials.gov was done using MeSH and non-MeSH disease condition terms. Studies were subcategorized to create the following groupings for descriptive analysis: ear, nose, allergy, voice, sleep, head and neck cancer, thyroid, and throat. Duke Health System visits were queried by using selected ICD-9 codes for otolaryngology and non-otolaryngology providers. Visits were grouped similarly to ClinicalTrials.gov for further analysis. Chi-square tests were used to explore differences between groups. A total of 1115 of 40,970 registered interventional trials were assigned to otolaryngology. Head and neck cancer trials predominated. Study models most frequently incorporated parallel design (54.6%), 2 study groups (46.6%), and randomization (69.1%). Phase 2 or 3 studies constituted 46.4% of the cohort. Comparison of the ClinicalTrials.gov database with administrative health system visit data by disease condition showed discordance between national research activity and clinical visit volume for patients with otolaryngology complaints. Analysis of otolaryngology-related clinical research as listed in ClinicalTrials.gov can inform patients, physicians, and policy makers about research focus areas. The relative burden of otolaryngology-associated conditions in our tertiary health system exceeds research activity within the field.

  6. Clinical Trials

    Medline Plus

    Full Text Available ... Departments of Defense and Veterans Affairs; private companies; universities; and nonprofit organizations. NIH Institutes and Centers (including ... our campus or trials NIH has sponsored at universities, medical centers, and hospitals. ClinicalTrials.gov View a ...

  7. Clinical Trials

    Medline Plus

    Full Text Available ... groups, companies, and organizations also sponsor clinical trials. Examples include Government Agencies, such as the U.S. Departments ... sponsor trials that test principles or strategies. For example, one NHLBI study explored whether the benefits of ...

  8. Social media in clinical trials.

    Science.gov (United States)

    Thompson, Michael A

    2014-01-01

    Social media has potential in clinical trials for pointing out trial issues, addressing barriers, educating, and engaging multiple groups involved in cancer clinical research. Social media is being used in clinical trials to highlight issues such as poor accrual and barriers; educate potential participants and physicians about clinical trial options; and is a potential indirect or direct method to improve accrual. We are moving from a passive "push" of information to patients to a "pull" of patients requesting information. Patients and advocates are often driving an otherwise reluctant health care system into communication. Online patient communities are creating new information repositories. Potential clinical trial participants are using the Twittersphere and other sources to learn about potential clinical trial options. We are seeing more organized patient-centric and patient-engaged forums with the potential to crowd source to improve clinical trial accrual and design. This is an evolving process that will meet many individual, institutional, and regulatory obstacles as we move forward in a changed research landscape.

  9. Clinical Trials

    Medline Plus

    Full Text Available ... identified earlier than they would be in general medical practice. This is because late-phase trials have large ... supporting clinical trials that have not only shaped medical practice around the world, but have improved the health ...

  10. Clinical Trials in Dentistry: A Cross-sectional Analysis of World Health Organization-International Clinical Trial Registry Platform.

    Science.gov (United States)

    Sivaramakrishnan, Gowri; Sridharan, Kannan

    2016-06-01

    Clinical trials are the back bone for evidence-based practice (EBP) and recently EBP has been considered the best source of treatment strategies available. Clinical trial registries serve as databases of clinical trials. As regards to dentistry in specific data on the number of clinical trials and their quality is lacking. Hence, the present study was envisaged. Clinical trials registered in WHO-ICTRP (http://apps.who.int/trialsearch/AdvSearch.aspx) in dental specialties were considered. The details assessed from the collected trials include: Type of sponsors; Health condition; Recruitment status; Study design; randomization, method of randomization and allocation concealment; Single or multi-centric; Retrospective or prospective registration; and Publication status in case of completed studies. A total of 197 trials were identified. Maximum trials were from United States (n = 30) and United Kingdom (n = 38). Seventy six trials were registered in Clinical Trials.gov, 54 from International Standards of Reporting Clinical Trials, 13 each from Australia and New Zealand Trial Register and Iranian Registry of Clinical Trials, 10 from German Clinical Trial Registry, eight each from Brazilian Clinical Trial Registry and Nederland's Trial Register, seven from Japan Clinical Trial Registry, six from Clinical Trial Registry of India and two from Hong Kong Clinical Trial Registry. A total of 78.7% studies were investigator-initiated and 64% were completed while 3% were terminated. Nearly four-fifths of the registered trials (81.7%) were interventional studies of which randomized were the large majority (94.4%) with 63.2% being open label, 20.4% using single blinding technique and 16.4% were doubled blinded. The number, methodology and the characteristics of clinical trials in dentistry have been noted to be poor especially in terms of being conducted multi-centrically, employing blinding and the method for randomization and allocation concealment. More emphasis has to be

  11. Clinical trials in dentistry in India: Analysis from trial registry.

    Science.gov (United States)

    Gowri, S; Kannan, Sridharan

    2017-01-01

    Evidence-based practice requires clinical trials to be performed. In India, if any clinical trial has to be performed, it has to be registered with clinical trial registry of India. Studies have shown that the report of clinical trials is poor in dentistry. Hence, the present study has been conducted to assess the type and trends of clinical trials being undertaken in dentistry in India over a span of 6 years. All the clinical trials which were registered with the Central Trial Registry of India (CTRI) (www.ctri.nic.in) from January 1, 2007 to March 3, 2014 were evaluated using the keyword "dental." Following information were collected for each of the clinical trials obtained from the search; number of centres (single center/multicentric), type of the institution undertaking the research (government/private/combined), study (observational/interventional), study design (randomized/single blinded/double-blinded), type of health condition, type of participants (healthy/patients), sponsors (academia/commercial), phase of clinical trial (Phase 1/2/3/4), publication details (published/not published), whether it was a postgraduate thesis or not and prospective or retrospective registration of clinical trials, methodological quality (method of randomization, allocation concealment). Descriptive statistics was used for analysis of various categories. Trend analysis was done to assess the changes over a period of time. The search yielded a total of 84 trials of which majority of them were single centered. Considering the study design more than half of the registered clinical trials were double-blinded (47/84 [56%]). With regard to the place of conducting a trial, most of the trials were planned to be performed in private hospitals (56/84 [66.7%]). Most (79/84, 94.1%) of the clinical trials were interventional while only 5/84 (5.9%) were observational. Majority (65/84, 77.4%) of the registered clinical trials were recruiting patients while the rest were being done in healthy

  12. Linking ClinicalTrials.gov and PubMed to track results of interventional human clinical trials.

    Directory of Open Access Journals (Sweden)

    Vojtech Huser

    Full Text Available OBJECTIVE: In an effort to understand how results of human clinical trials are made public, we analyze a large set of clinical trials registered at ClinicalTrials.gov, the world's largest clinical trial registry. MATERIALS AND METHODS: We considered two trial result artifacts: (1 existence of a trial result journal article that is formally linked to a registered trial or (2 the deposition of a trial's basic summary results within the registry. RESULTS: The study sample consisted of 8907 completed, interventional, phase 2-or-higher clinical trials that were completed in 2006-2009. The majority of trials (72.2% had no structured trial-article link present. A total of 2367 trials (26.6% deposited basic summary results within the registry. Of those, 969 trials (10.9% were classified as trials with extended results and 1398 trials (15.7% were classified as trials with only required basic results. The majority of the trials (54.8% had no evidence of results, based on either linked result articles or basic summary results (silent trials, while a minimal number (9.2% report results through both registry deposition and publication. DISCUSSION: Our study analyzes the body of linked knowledge around clinical trials (which we refer to as the "trialome". Our results show that most trials do not report results and, for those that do, there is minimal overlap in the types of reporting. We identify several mechanisms by which the linkages between trials and their published results can be increased. CONCLUSION: Our study shows that even when combining publications and registry results, and despite availability of several information channels, trial sponsors do not sufficiently meet the mandate to inform the public either via a linked result publication or basic results submission.

  13. Clinical Trials

    Medline Plus

    Full Text Available ... other expenses (for example, travel and child care)? Who will be in charge of my care? What will happen after the trial? Taking part in a clinical trial is your decision. Talk with your doctor about all of your treatment ...

  14. EPICS-based control and data acquisition for the APS slope profiler (Conference Presentation)

    Science.gov (United States)

    Sullivan, Joseph; Assoufid, Lahsen; Qian, Jun; Jemian, Peter R.; Mooney, Tim; Rivers, Mark L.; Goetze, Kurt; Sluiter, Ronald L.; Lang, Keenan

    2016-09-01

    The motion control, data acquisition and analysis system for APS Slope Measuring Profiler was implemented using the Experimental Physics and Industrial Control System (EPICS). EPICS was designed as a framework with software tools and applications that provide a software infrastructure used in building distributed control systems to operate devices such as particle accelerators, large experiments and major telescopes. EPICS was chosen to implement the APS Slope Measuring Profiler because it is also applicable to single purpose systems. The control and data handling capability available in the EPICS framework provides the basic functionality needed for high precision X-ray mirror measurement. Those built in capabilities include hardware integration of high-performance motion control systems (3-axis gantry and tip-tilt stages), mirror measurement devices (autocollimator, laser spot camera) and temperature sensors. Scanning the mirror and taking measurements was accomplished with an EPICS feature (the sscan record) which synchronizes motor positioning with measurement triggers and data storage. Various mirror scanning modes were automatically configured using EPICS built-in scripting. EPICS tools also provide low-level image processing (areaDetector). Operation screens were created using EPICS-aware GUI screen development tools.

  15. The German version of the Expanded Prostate Cancer Index Composite (EPIC): translation, validation and minimal important difference estimation.

    Science.gov (United States)

    Umbehr, Martin H; Bachmann, Lucas M; Poyet, Cedric; Hammerer, Peter; Steurer, Johann; Puhan, Milo A; Frei, Anja

    2018-02-20

    No official German translation exists for the 50-item Expanded Prostate Cancer Index Composite (EPIC), and no minimal important difference (MID) has been established yet. The aim of the study was to translate and validate a German version of the EPIC with cultural adaptation to the different German speaking countries and to establish the MID. We translated and culturally adapted the EPIC into German. For validation, we included a consecutive subsample of 92 patients with localized prostate cancer undergoing radical prostatectomy who participated the Prostate Cancer Outcomes Cohort. Baseline and follow-up assessments took place before and six weeks after prostatectomy in 2010 and 2011. We assessed the EPIC, EORTC QLQ-PR25, Feeling Thermometer, SF-36 and a global rating of health state change variable. We calculated the internal consistency, test-retest reliability, construct validity, responsiveness and MID. For most EPIC domains and subscales, our a priori defined criteria for reliability were fulfilled (construct reliability: Cronbach's alpha 0.7-0.9; test-retest reliability: intraclass-correlation coefficient ≥ 0.7). Cross-sectional and longitudinal correlations between EPIC and EORTC QLQ-PR25 domains ranged from 0.14-0.79, and 0.06-0.5 and 0.08-0.72 for Feeling Thermometer and SF-36, respectively. We established MID values of 10, 4, 12, and 6 for the urinary, bowel, sexual and hormonal domain. The German version of the EPIC is reliable, responsive and valid to measure HRQL in prostate cancer patients and is now available in German language. With the suggested MID we provide interpretation to what extent changes in HRQL are clinically relevant for patients. Hence, study results are of interest beyond German speaking countries.

  16. Extrasolar Planetary Imaging Coronagraph (EPIC)

    Science.gov (United States)

    Clampin, Mark

    2009-01-01

    The Extrasolar Planetary Imaging Coronagraph (EPIC) is a proposed NASA Exoplanet Probe mission to image and characterize extrasolar giant planets. EPIC will provide insights into the physical nature and architecture of a variety of planets in other solar systems. Initially, it will detect and characterize the atmospheres of planets identified by radial velocity surveys, determine orbital inclinations and masses and characterize the atmospheres around A and F type stars which cannot be found with RV techniques. It will also observe the inner spatial structure of exozodiacal disks. EPIC has a heliocentric Earth trailing drift-away orbit, with a 5 year mission lifetime. The robust mission design is simple and flexible ensuring mission success while minimizing cost and risk. The science payload consists of a heritage optical telescope assembly (OTA), and visible nulling coronagraph (VNC) instrument. The instrument achieves a contrast ratio of 10^9 over a 5 arcsecond field-of-view with an unprecedented inner working angle of 0.13 arcseconds over the spectral range of 440-880 nm. The telescope is a 1.65 meter off-axis Cassegrain with an OTA wavefront error of lambda/9, which when coupled to the VNC greatly reduces the requirements on the large scale optics.

  17. 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.

  18. 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.

  19. OARSI Clinical Trials Recommendations: Design and conduct of clinical trials of rehabilitation interventions for osteoarthritis.

    Science.gov (United States)

    Fitzgerald, G K; Hinman, R S; Zeni, J; Risberg, M A; Snyder-Mackler, L; Bennell, K L

    2015-05-01

    A Task Force of the Osteoarthritis Research Society International (OARSI) has previously published a set of guidelines for the conduct of clinical trials in osteoarthritis (OA) of the hip and knee. Limited material available on clinical trials of rehabilitation in people with OA has prompted OARSI to establish a separate Task Force to elaborate guidelines encompassing special issues relating to rehabilitation of OA. The Task Force identified three main categories of rehabilitation clinical trials. The categories included non-operative rehabilitation trials, post-operative rehabilitation trials, and trials examining the effectiveness of devices (e.g., assistive devices, bracing, physical agents, electrical stimulation, etc.) that are used in rehabilitation of people with OA. In addition, the Task Force identified two main categories of outcomes in rehabilitation clinical trials, which include outcomes related to symptoms and function, and outcomes related to disease modification. The guidelines for rehabilitation clinical trials provided in this report encompass these main categories. The report provides guidelines for conducting and reporting on randomized clinical trials. The topics include considerations for entering patients into trials, issues related to conducting trials, considerations for selecting outcome measures, and recommendations for statistical analyses and reporting of results. The focus of the report is on rehabilitation trials for hip, knee and hand OA, however, we believe the content is broad enough that it could be applied to rehabilitation trials for other regions as well. Copyright © 2015 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved.

  20. The PSI web interface to the EPICS channel archiver

    International Nuclear Information System (INIS)

    Gaudenz Jud; Luedeke, A.; Portmann, W.

    2012-01-01

    the EPICS (Experimental Physics and Industrial Control System) channel archiver is used at different facilities at PSI (Paul Scherrer Institute) like the Swiss Light Source or the medical cyclotron. The EPICS channel archiver is a powerful tool to collect control system data of thousands of EPICS process variables with rates of many Hertz each to an archive for later retrieval. Within the package of the channel archiver version 2 you get a Java application for graphical data retrieval and a command line tool for data extraction into different file formats. For the Paul Scherrer Institute (PSI) we wanted a possibility to retrieve the archived data from a web interface. It was desired to have flexible retrieval functions and to allow interchanging data references by e-mail. This web interface has been implemented by the PSI controls group and has now been in operation for several years. This paper will highlight the special features of the PSI web interface to the EPICS channel archiver

  1. [Clinical trials in nursing journals].

    Science.gov (United States)

    Di Giulio, Paola; Campagna, Sara; Dimonte, Valerio

    2014-01-01

    Clinical trials are pivotal for the development of nursing knowledge. To describe the clinical trials published in nursing journals in the last two years and propose some general reflections on nursing research. A search with the key-word trial was done on PubMed (2009-2013) on Cancer Nursing, European Journal of Oncology Nursing, International Journal of Nursing Studies, Journal of Advanced Nursing, Journal of Clinical Nursing and Nursing Research. Of 228 trials identified, 104 (45.8%) were published in the last 2 years. Nurses from Asian countries published the larger number of trials. Educational and supportive interventions were the most studied (61/104 trials), followed by clinical interventions (33/104). Samples were limited and most trials are monocentric. A growing number of trials is published, on issues relevant for the nursing profession, however larger samples and multicentric studies would be necessary.

  2. Clinical trial optimization: Monte Carlo simulation Markov model for planning clinical trials recruitment.

    Science.gov (United States)

    Abbas, Ismail; Rovira, Joan; Casanovas, Josep

    2007-05-01

    The patient recruitment process of clinical trials is an essential element which needs to be designed properly. In this paper we describe different simulation models under continuous and discrete time assumptions for the design of recruitment in clinical trials. The results of hypothetical examples of clinical trial recruitments are presented. The recruitment time is calculated and the number of recruited patients is quantified for a given time and probability of recruitment. The expected delay and the effective recruitment durations are estimated using both continuous and discrete time modeling. The proposed type of Monte Carlo simulation Markov models will enable optimization of the recruitment process and the estimation and the calibration of its parameters to aid the proposed clinical trials. A continuous time simulation may minimize the duration of the recruitment and, consequently, the total duration of the trial.

  3. Credentialing for participation in clinical trials

    International Nuclear Information System (INIS)

    Followill, David S.; Urie, Marcia; Galvin, James M.; Ulin, Kenneth; Xiao, Ying; FitzGerald, Thomas J.

    2012-01-01

    The National Cancer Institute (NCI) clinical cooperative groups have been instrumental over the past 50 years in developing clinical trials and evidence-based clinical trial processes for improvements in patient care. The cooperative groups are undergoing a transformation process to launch, conduct, and publish clinical trials more rapidly. Institutional participation in clinical trials can be made more efficient and include the expansion of relationships with international partners. This paper reviews the current processes that are in use in radiation therapy trials and the importance of maintaining effective credentialing strategies to assure the quality of the outcomes of clinical trials. The paper offers strategies to streamline and harmonize credentialing tools and processes moving forward as the NCI undergoes transformative change in the conduct of clinical trials.

  4. Credentialing for participation in clinical trials

    Energy Technology Data Exchange (ETDEWEB)

    Followill, David S. [Radiological Physics Center, Department of Radiation Physics, University of Texas MD Anderson Cancer Center, Houston, TX (United States); Urie, Marcia [Quality Assurance Review Center, Department of Radiation Oncology, University of Massachusetts Medical School, Lincoln, RI (United States); Galvin, James M. [Department of Radiation Oncology, Jefferson Medical College, Thomas Jefferson University, Philadelphia, PA (United States); Radiation Therapy Oncology Group, Philadelphia, PA (United States); Ulin, Kenneth [Quality Assurance Review Center, Department of Radiation Oncology, University of Massachusetts Medical School, Lincoln, RI (United States); Department of Radiation Oncology, University of Massachusetts Medical School, Worcester, MA (United States); Xiao, Ying [Department of Radiation Oncology, Jefferson Medical College, Thomas Jefferson University, Philadelphia, PA (United States); Radiation Therapy Oncology Group, Philadelphia, PA (United States); FitzGerald, Thomas J., E-mail: dfollowi@mdanderson.org [Quality Assurance Review Center, Department of Radiation Oncology, University of Massachusetts Medical School, Lincoln, RI (United States); Department of Radiation Oncology, University of Massachusetts Medical School, Worcester, MA (United States)

    2012-12-26

    The National Cancer Institute (NCI) clinical cooperative groups have been instrumental over the past 50 years in developing clinical trials and evidence-based clinical trial processes for improvements in patient care. The cooperative groups are undergoing a transformation process to launch, conduct, and publish clinical trials more rapidly. Institutional participation in clinical trials can be made more efficient and include the expansion of relationships with international partners. This paper reviews the current processes that are in use in radiation therapy trials and the importance of maintaining effective credentialing strategies to assure the quality of the outcomes of clinical trials. The paper offers strategies to streamline and harmonize credentialing tools and processes moving forward as the NCI undergoes transformative change in the conduct of clinical trials.

  5. Clinical Trials

    Medline Plus

    Full Text Available ... trial found that one of the combinations worked much better than the other for moderate persistent asthma. The results provided important treatment information for doctors and patients. The results from other clinical trials show what doesn't work or may cause harm. For example, the NHLBI ...

  6. Clinical Trials

    Medline Plus

    Full Text Available ... Children and Clinical Studies Program has been successfully developed and evaluated to fill an important gap in ... Possible Benefits Taking part in a clinical trial can have many benefits. For example, you may gain ...

  7. Clinical Trials

    Medline Plus

    Full Text Available ... you may get tests or treatments in a hospital, clinic, or doctor's office. In some ways, taking ... people will need to travel or stay in hospitals to take part in clinical trials. For example, ...

  8. EPIC: Helping School Life and Family Support Each Other.

    Science.gov (United States)

    Montgomery, David

    1992-01-01

    Born out of a 1981 murder, Buffalo (New York) Public Schools' EPIC (Effective Parenting Information for Children) program successfully combines parenting, effective teaching, and community programs to help family and school life support each other. Under EPIC, teachers are advised to help students acquire 23 skills involving self-esteem, rules,…

  9. Clinical trial methodology

    National Research Council Canada - National Science Library

    Peace, Karl E; Chen, Ding-Geng

    2011-01-01

    ... in the pharmaceutical industry, Clinical trial methodology emphasizes the importance of statistical thinking in clinical research and presents the methodology as a key component of clinical research...

  10. The implement of the interface between EPICS and LabVIEW

    International Nuclear Information System (INIS)

    Liu Jia; Wang Chunhong

    2009-01-01

    The control system of BEPCII (Beijing Electron Positron Collider) is based on EPICS (Experimental Physics and Industrial Control System). LabVIEW is often used to develop data acquisition system on Windows platform. EPICS IOC version 3.14 or later, can be currently running on windows. The SharedMemory developed by SNS (Spallation Neutron Source) can implement the interface between Windows IOC and LabVIEW. The paper describes the method how to use SharedMemory and a application of magnet measurement system, so that LabVIEW and EPICS can share data each other. (authors)

  11. OARSI Clinical Trials Recommendations: Soluble biomarker assessments in clinical trials in osteoarthritis.

    Science.gov (United States)

    Kraus, V B; Blanco, F J; Englund, M; Henrotin, Y; Lohmander, L S; Losina, E; Önnerfjord, P; Persiani, S

    2015-05-01

    The objective of this work was to describe requirements for inclusion of soluble biomarkers in osteoarthritis (OA) clinical trials and progress toward OA-related biomarker qualification. The Guidelines for Biomarkers Working Group, representing experts in the field of OA biomarker research from both academia and industry, convened to discuss issues related to soluble biomarkers and to make recommendations for their use in OA clinical trials based on current knowledge and anticipated benefits. This document summarizes current guidance on use of biomarkers in OA clinical trials and their utility at five stages, including preclinical development and phase I to phase IV trials. As demonstrated by this summary, biomarkers can provide value at all stages of therapeutics development. When resources permit, we recommend collection of biospecimens in all OA clinical trials for a wide variety of reasons but in particular, to determine whether biomarkers are useful in identifying those individuals most likely to receive clinically important benefits from an intervention; and to determine whether biomarkers are useful for identifying individuals at earlier stages of OA in order to institute treatment at a time more amenable to disease modification. Copyright © 2015 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved.

  12. Parents' perceived obstacles to pediatric clinical trial participation: Findings from the clinical trials transformation initiative.

    Science.gov (United States)

    Greenberg, Rachel G; Gamel, Breck; Bloom, Diane; Bradley, John; Jafri, Hasan S; Hinton, Denise; Nambiar, Sumathi; Wheeler, Chris; Tiernan, Rosemary; Smith, P Brian; Roberts, Jamie; Benjamin, Daniel K

    2018-03-01

    Enrollment of children into pediatric clinical trials remains challenging. More effective strategies to improve recruitment of children into trials are needed. This study used in-depth qualitative interviews with parents who were approached to enroll their children in a clinical trial in order to gain an understanding of the barriers to pediatric clinical trial participation. Twenty-four parents whose children had been offered the opportunity to participate in a clinical trial were interviewed: 19 whose children had participated in at least 1 clinical trial and 5 who had declined participation in any trial. Each study aspect, from the initial explanation of the study to the end of the study, can affect the willingness of parents to consent to the proposed study and future studies. Establishing trust, appropriate timing, a transparent discussion of risks and benefits oriented to the layperson, and providing motivation for children to participate were key factors that impacted parents' decisions. In order for clinical trial accrual to be successful, parents' priorities and considerations must be a central focus, beginning with initial trial design. The recommendations from the parents who participated in this study can be used to support budget allocations that ensure adequate training of study staff and improved staffing on nights and weekends. Studies of parent responses in outpatient settings and additional inpatient settings will provide valuable information on the consent process from the child's and parent's perspectives. Further studies are needed to explore whether implementation of such strategies will result in improved recruitment for pediatric clinical trials.

  13. Collaborative development of the EPICS Qt framework Phase I Final Report

    Energy Technology Data Exchange (ETDEWEB)

    Mayssat, Robert E. [Lyncean Technologies, Inc., Palo Alto, CA (United States)

    2015-01-15

    At Lyncean, a private company spun-off from technology developed at the SLAC National Lab, we have been using EPICS for over a decade. EPICS is ubiquitous on our flagship product – the Compact Light Source. EPICS is not only used to control our laser and accelerator systems, but also to control our x-ray beamlines. The goal of this SBIR is for Lyncean Technologies to spearhead a worldwide collaborative effort for the development of control system tools for EPICS using the Qt framework, a C++-based coding environment that could serve as a competitive alternative to the Java-based Control System Studio (CSS). This grant's Phase I, not unlike a feasibility study, is designed for planning and scoping the preparatory work needed for Phase II or other funding opportunities. The three main objectives of this Phase I are (1) to become better acquainted with the existing EPICS Qt software and Qt framework in order to evaluate the best options for ongoing development, (2) to demonstrate that our engineers can lead the EPICS community and jump-start the Qt collaboration, and (3) to identify a scope for our future work with solicited feedback from the EPICS community. This Phase I report includes key technical findings. It clarifies the differences between the two apparently-competing EPICS Qt implementations, caQtDM and the QE Framework; it explains how to create python-bindings, and compares Qt graphical libraries. But this report is also a personal story that narrates the birth of a collaboration. Starting a collaboration is not the work of a single individual, but the work of many. Therefore this report is also an attempt to publicly give credit to many who supported the effort. The main take-away from this grant is the successful birth of an EPICS Qt collaboration, seeded with existing software from the PSI and the Australian Synchrotron. But a lot more needs to be done for the collaboration founders' vision to be realized, and for the collaboration to reach

  14. Construction of a remote controlled monitoring system with GPIB devices and EPICS

    International Nuclear Information System (INIS)

    Yoshikawa, Takeshi; Yamamoto, Noboru.

    1995-01-01

    The Experimental Physics and Industrial Control System (EPICS) has been used for the accelerator control system in recent years. EPICS has rich set of tools to create application with Graphical User Interface (GUI). It reduces the load of complex programming for GUI and shortens the application development period. This paper will describe the remote temperature monitoring system using EPICS. (author)

  15. Patient engagement in clinical trials: The Clinical Trials Transformation Initiative's leadership from theory to practical implementation.

    Science.gov (United States)

    Patrick-Lake, Bray

    2018-02-01

    Patient engagement is an increasingly important aspect of successful clinical trials. Over the past decade, as patient group involvement in clinical trials has continued to increase and diversify, the Clinical Trials Transformation Initiative has not only recognized the crucial role patients play in improving the clinical trial enterprise but also made a deep commitment to help grow and shape the emerging field of patient engagement. This article describes the evolution of patient engagement including the origins of the patient engagement movement; barriers to successful engagement and remaining challenges to full and valuable collaboration between patient groups and trial sponsors; and Clinical Trials Transformation Initiative's role in influencing the field through organizational practices, formal project work and resulting recommendations, and external advocacy efforts.

  16. Design for Change : EPIC pillars for Persuasive Design for Health

    NARCIS (Netherlands)

    Tjin-Kam-Jet-Siemons, Liseth; van Gemert-Pijnen, Julia E.W.C.

    2016-01-01

    What makes technology now truly empathic? How to develop designs that matter? We apply the EPIC for change model for persuasive and empathic designs. EPIC stands for: • Engagement: Creating experience, flow using persuasive strategies and triggers in development, using positive psychology concepts;

  17. Transparency and public accessibility of clinical trial information in Croatia: how it affects patient participation in clinical trials.

    Science.gov (United States)

    Šolić, Ivana; Stipčić, Ana; Pavličević, Ivančica; Marušić, Ana

    2017-06-15

    Despite increased visibility of clinical trials through international trial registries, patients often remain uninformed of their existence, especially if they do not have access to adequate information about clinical research, including the language of the information. The aim of this study was to describe the context for transparency of clinical trials in Croatia in relation to countries in Central and Eastern Europe, and to assess how informed Croatian patients are about clinical trials and their accessibility. We assessed the transparency of clinical trials from the data available in the public domain. We also conducted an anonymous survey on a convenience sample of 257 patients visiting two family medicine offices or an oncology department in south Croatia, and members of national patients' associations. Despite legal provisions for transparency of clinical trials in Croatia, they are still not sufficiently visible in the public domain. Among countries from Central and Eastern Europe, Croatia has the fewest number of registered trials in the EU Clinical Trials Registry. 66% of the patients in the survey were aware of the existence of clinical trials but only 15% were informed about possibilities of participating in a trial. Although 58% of the respondents were willing to try new treatments, only 6% actually participated in a clinical trial. Only 2% of the respondents were aware of publicly available trial registries. Our study demonstrates that there is low transparency of clinical trials in Croatia, and that Croatian patients are not fully aware of clinical trials and the possibilities of participating in them, despite reported availability of Internet resources and good communication with their physicians. There is a need for active policy measures to increase the awareness of and access to clinical trials to patients in Croatia, particularly in their own language.

  18. Clinical Trials

    Medline Plus

    Full Text Available ... Wide Range of Audiences The Children and Clinical Studies Program has been successfully developed and evaluated to fill an important gap in information and education for parents, clinicians, researchers, children, and the general public. What to Expect During a clinical trial, doctors, ...

  19. Chronicle and the epic: Machado de Assis in homeric verses

    Directory of Open Access Journals (Sweden)

    Ionara Satin

    2015-12-01

    Full Text Available The aim of this study is to show the presence of classical epic, Homer's Iliad, in the chronicle of Machado de Assis, analyzing the intertextual dialogue between Machado de Assis and the epic poem by Homer, considering the concept of intertextuality developed by Julia Kristeva from philosophical conceptions of Bakhtin. In the chronicle of March 18, 1894 for the newspaper Gazeta de Notícias on sunday column "A Semana", Machado de Assis crosses Homer's epic to his chronicle, rewrites the epic text for the daily issues of his weekly column. To Tiphaine Samoyault, writing is rewriting, "stand on the existing foundations and contribute to a continued creation" (2008, p. 77 one of the principles of intertextuality. It was observed that from the reading and assimilation of the classic poem, Machado de Assis can approach so far genres, bringing the verses to his prose, leaving it closer to poetry. In this sense, we can see the richness of Machado de Assis chronicles, often left on the sidelines in favor of his short stories and romances. In addition, the dialogue, to rewrite the epic in his chronicle, Machado seems to contribute to this "continuous creation", reviving the memory of literature and emphasizing the permanence of classical work.

  20. OARSI Clinical Trials Recommendations: Design and conduct of clinical trials for hand osteoarthritis.

    Science.gov (United States)

    Kloppenburg, M; Maheu, E; Kraus, V B; Cicuttini, F; Doherty, M; Dreiser, R-L; Henrotin, Y; Jiang, G-L; Mandl, L; Martel-Pelletier, J; Nelson, A E; Neogi, T; Pelletier, J-P; Punzi, L; Ramonda, R; Simon, L S; Wang, S

    2015-05-01

    Hand osteoarthritis (OA) is a very frequent disease, but yet understudied. However, a lot of works have been published in the past 10 years, and much has been done to better understand its clinical course and structural progression. Despite this new knowledge, few therapeutic trials have been conducted in hand OA. The last OARSI recommendations for the conduct of clinical trials in hand OA dates back to 2006. The present recommendations aimed at updating previous recommendations, by incorporating new data. The purpose of this expert opinion, consensus driven exercise is to provide evidence-based guidance on the design, execution and analysis of clinical trials in hand OA, where published evidence is available, supplemented by expert opinion, where evidence is lacking, to perform clinical trials in hand OA, both for symptom and for structure-modification. They indicate core outcome measurement sets for studies in hand OA, and list the methods and instruments that should be used to measure symptoms or structure. For both symptom- and structure-modification, at least pain, physical function, patient global assessment, HR-QoL, joint activity and hand strength should be assessed. In addition, for structure-modification trials, structural progression should be measured by radiographic changes. We also provide a research agenda listing many unsolved issues that seem to most urgently need to be addressed from the perspective of performing "good" clinical trials in hand OA. These updated OARSI recommendations should allow for better standardizing the conduct of clinical trials in hand OA in the next future. Copyright © 2015 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved.

  1. Lessons learned enhancing EPICS CA for LANSCE timed and flavored data

    International Nuclear Information System (INIS)

    Hill, Jeffrey O.

    2009-01-01

    A previous paper described an upgrade to EPICS enabling client side tools at LANSCE to receive subscription updates filtered selectively to match a logical configuration of LANSCE beam gates, as configured by the control room. The upgrade required fundamental changes in the EPICS core components. First, the event queue in the EPICS server was upgraded to buffer record (function block) and device specific parameters accessed generically via software interfaces for introspection of 3rd party data. In contrast, event queues in previous versions of EPICS were strictly limited to buffering only value, timestamp, and alarm status tuples. Second, the Channel Access server is being upgraded to filter subscription updates. In this follow on paper some necessary design changes mid-project and the lessons learned during the software development will be described.

  2. A shared memory based interface of MARTe with EPICS for real-time applications

    International Nuclear Information System (INIS)

    Yun, Sangwon; Neto, André C.; Park, Mikyung; Lee, Sangil; Park, Kaprai

    2014-01-01

    Highlights: • We implemented a shared memory based interface of MARTe with EPICS. • We implemented an EPICS module supporting device and driver support. • We implemented an example EPICS IOC and CSS OPI for evaluation. - Abstract: The Multithreaded Application Real-Time executor (MARTe) is a multi-platform C++ middleware designed for the implementation of real-time control systems. It currently supports the Linux, Linux + RTAI, VxWorks, Solaris and MS Windows platforms. In the fusion community MARTe is being used at JET, COMPASS, ISTTOK, FTU and RFX in fusion [1]. The Experimental Physics and Industrial Control System (EPICS), a standard framework for the control systems in KSTAR and ITER, is a set of software tools and applications which provide a software infrastructure for use in building distributed control systems to operate devices. For a MARTe based application to cooperate with an EPICS based application, an interface layer between MARTe and EPICS is required. To solve this issue, a number of interfacing solutions have been proposed and some of them have been implemented. Nevertheless, a new approach is required to mitigate the functional limitations of existing solutions and to improve their performance for real-time applications. This paper describes the design and implementation of a shared memory based interface between MARTe and EPICS

  3. A shared memory based interface of MARTe with EPICS for real-time applications

    Energy Technology Data Exchange (ETDEWEB)

    Yun, Sangwon, E-mail: yunsw@nfri.re.kr [National Fusion Research Institute (NFRI), Gwahangno 169-148, Yuseong-Gu, Daejeon 305-806 (Korea, Republic of); Neto, André C. [Associação EURATOM/IST, Instituto de Plasmas e Fusão Nuclear, Instituto Superior Técnico, Universidade Técnica de Lisboa, P-1049-001 Lisboa (Portugal); Park, Mikyung; Lee, Sangil; Park, Kaprai [National Fusion Research Institute (NFRI), Gwahangno 169-148, Yuseong-Gu, Daejeon 305-806 (Korea, Republic of)

    2014-05-15

    Highlights: • We implemented a shared memory based interface of MARTe with EPICS. • We implemented an EPICS module supporting device and driver support. • We implemented an example EPICS IOC and CSS OPI for evaluation. - Abstract: The Multithreaded Application Real-Time executor (MARTe) is a multi-platform C++ middleware designed for the implementation of real-time control systems. It currently supports the Linux, Linux + RTAI, VxWorks, Solaris and MS Windows platforms. In the fusion community MARTe is being used at JET, COMPASS, ISTTOK, FTU and RFX in fusion [1]. The Experimental Physics and Industrial Control System (EPICS), a standard framework for the control systems in KSTAR and ITER, is a set of software tools and applications which provide a software infrastructure for use in building distributed control systems to operate devices. For a MARTe based application to cooperate with an EPICS based application, an interface layer between MARTe and EPICS is required. To solve this issue, a number of interfacing solutions have been proposed and some of them have been implemented. Nevertheless, a new approach is required to mitigate the functional limitations of existing solutions and to improve their performance for real-time applications. This paper describes the design and implementation of a shared memory based interface between MARTe and EPICS.

  4. Types of Cancer Clinical Trials

    Science.gov (United States)

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

  5. EPICS: Experimental Physics and Industrial Control System

    Science.gov (United States)

    Epics Development Team

    2013-02-01

    EPICS is a set of software tools and applications developed collaboratively and used to create distributed soft real-time control systems for scientific instruments such as particle accelerators and telescopes. Such distributed control systems typically comprise tens or even hundreds of computers, networked together to allow communication between them and to provide control and feedback of the various parts of the device from a central control room, or even remotely over the internet. EPICS uses Client/Server and Publish/Subscribe techniques to communicate between the various computers. A Channel Access Gateway allows engineers and physicists elsewhere in the building to examine the current state of the IOCs, but prevents them from making unauthorized adjustments to the running system. In many cases the engineers can make a secure internet connection from home to diagnose and fix faults without having to travel to the site. EPICS is used by many facilities worldwide, including the Advanced Photon Source at Argonne National Laboratory, Fermilab, Keck Observatory, Laboratori Nazionali di Legnaro, Brazilian Synchrotron Light Source, Los Alamos National Laboratory, Australian Synchrotron, and Stanford Linear Accellerator Center.

  6. Portfolio of prospective clinical trials including brachytherapy: an analysis of the ClinicalTrials.gov database.

    Science.gov (United States)

    Cihoric, Nikola; Tsikkinis, Alexandros; Miguelez, Cristina Gutierrez; Strnad, Vratislav; Soldatovic, Ivan; Ghadjar, Pirus; Jeremic, Branislav; Dal Pra, Alan; Aebersold, Daniel M; Lössl, Kristina

    2016-03-22

    To evaluate the current status of prospective interventional clinical trials that includes brachytherapy (BT) procedures. The records of 175,538 (100 %) clinical trials registered at ClinicalTrials.gov were downloaded on September 2014 and a database was established. Trials using BT as an intervention were identified for further analyses. The selected trials were manually categorized according to indication(s), BT source, applied dose rate, primary sponsor type, location, protocol initiator and funding source. We analyzed trials across 8 available trial protocol elements registered within the database. In total 245 clinical trials were identified, 147 with BT as primary investigated treatment modality and 98 that included BT as an optional treatment component or as part of the standard treatment. Academic centers were the most frequent protocol initiators in trials where BT was the primary investigational treatment modality (p < 0.01). High dose rate (HDR) BT was the most frequently investigated type of BT dose rate (46.3 %) followed by low dose rate (LDR) (42.0 %). Prostate was the most frequently investigated tumor entity in trials with BT as the primary treatment modality (40.1 %) followed by breast cancer (17.0 %). BT was rarely the primary investigated treatment modality for cervical cancer (6.8 %). Most clinical trials using BT are predominantly in early phases, investigator-initiated and with low accrual numbers. Current investigational activities that include BT mainly focus on prostate and breast cancers. Important questions concerning the optimal usage of BT will not be answered in the near future.

  7. Quality Assurance for Clinical Trials

    Science.gov (United States)

    Ibbott, Geoffrey S.; Haworth, Annette; Followill, David S.

    2013-01-01

    Cooperative groups, of which the Radiation Therapy Oncology Group is one example, conduct national clinical trials that often involve the use of radiation therapy. In preparation for such a trial, the cooperative group prepares a protocol to define the goals of the trial, the rationale for its design, and the details of the treatment procedure to be followed. The Radiological Physics Center (RPC) is one of several quality assurance (QA) offices that is charged with assuring that participating institutions deliver doses that are clinically consistent and comparable. The RPC does this by conducting a variety of independent audits and credentialing processes. The RPC has compiled data showing that credentialing can help institutions comply with the requirements of a cooperative group clinical protocol. Phantom irradiations have been demonstrated to exercise an institution’s procedures for planning and delivering advanced external beam techniques (1–3). Similarly, RPC data indicate that a rapid review of patient treatment records or planning procedures can improve compliance with clinical trials (4). The experiences of the RPC are presented as examples of the contributions that a national clinical trials QA center can make to cooperative group trials. These experiences illustrate the critical need for comprehensive QA to assure that clinical trials are successful and cost-effective. The RPC is supported by grants CA 10953 and CA 81647 from the National Cancer Institute, NIH, DHHS. PMID:24392352

  8. Pirate Alterity and Mimesis in Colonial Epic Poetry

    Directory of Open Access Journals (Sweden)

    Javier de Navascués

    2016-05-01

    Full Text Available Pirate representation is studied in a series of Epic poems in the late sixteenth century and early seventeenth century. The ambiguous image of the English enemy is read in texts by Juan de Miramontes, Pedro de Oña, Martín del Barco Centenera and Juan de Castellanos, among others. On the one hand, Colonial Epic ignores some important differences between privateers and pirates since the privateering had been legally accepted by all European nations, including Spain. Besides, Pirate is always called «Lutheran» and revealing its absolute otherness with respect to the Catholic model. On the other hand, it proposes a laudatory epics enemy painting from the imitation of the values accepted by the colonial society. The relationship between the Spanish hero and the privateer is represented not in a vertical direction, as could happen between colonizer and colonized subject, but on a level of rivalry.

  9. Clinical trials. A pending subject.

    Science.gov (United States)

    Gil-Extremera, B; Jiménez-López, P; Mediavilla-García, J D

    2018-04-01

    Clinical trials are essential tools for the progress of clinical medicine in its diagnostic and therapeutic aspects. Since the first trial in 1948, which related tobacco use with lung cancer, there have been more than 150,000 clinical trials to date in various areas (paediatrics, cardiology, oncology, endocrinology, etc.). This article highlights the importance for all physicians to participate, over the course of their professional career, in a clinical trial, due to the inherent benefits for patients, the progress of medicine and for curricular prestige. The authors have created a synthesis of their experience with clinical trials on hypertension, diabetes, dyslipidaemia and ischaemic heart disease over the course of almost 3 decades. Furthermore, a brief reference has been made to the characteristics of a phase I unit, as well as to a number of research studies currently underway. Copyright © 2017 Elsevier España, S.L.U. and Sociedad Española de Medicina Interna (SEMI). All rights reserved.

  10. Cross-Over Clinical Trials?

    Directory of Open Access Journals (Sweden)

    Latif Gachkar

    2017-01-01

    Full Text Available Abstract Cross-Over Clinical Trials in comparison with Parallel groups clinical trials have some advantages such as control of confounding variables, small sample size, and short time to implement the research project. But this type of research has few essential limitations that discusses in this monogram.

  11. Formulation of EPICS record naming conventions in J-PARC linac and RCS. Build process of unique and standardized name

    International Nuclear Information System (INIS)

    Fukuta, Shinpei; Kawase, Masato; Kikuzawa, Nobuhiro; Watanabe, Kazuhiko; Sakaki, Hironao; Takahashi, Hiroki

    2011-02-01

    J-PARC (Japan Proton Accelerator Research Complex) accelerator devices are controlled by the use of the software called EPICS (Experimental Physics and Industrial Control System). The unique name called an EPICS record is given to a control signal and data acquisition, Accelerator device control is achieved using the EPICS record. The requirement for the EPICS record name is 2 points; (1) no overlap of the EPICS record name, (2) the control contents can be easily imagined from the EPICS record name. To manage the EPICS record using relational database for the information management of the accelerator device in J-PARC, the naming structure is required so that a mechanical process can be performed easily. It was necessary to standardize the EPICS record name and the EPICS record structure to achieve these requirements. Therefore, we have formulated a guideline called 'EPICS record naming conventions' to decide to an EPICS record name uniquely and standardization. The abbreviated key word list of the accelerator devices and the control signal that compose the EPICS record name is appended to the EPICS record naming conventions. (author)

  12. EPIC: A Framework for Using Video Games in Ethics Education

    Science.gov (United States)

    Schrier, Karen

    2015-01-01

    Ethics education can potentially be supplemented through the use of video games. This article proposes a novel framework (Ethics Practice and Implementation Categorization [EPIC] Framework), which helps educators choose games to be used for ethics education purposes. The EPIC Framework is derived from a number of classic moral development,…

  13. Connect high speed analog-digital converter with EPICS based on LabVIEW

    International Nuclear Information System (INIS)

    Wang Wei; Chi Yunlong

    2008-01-01

    This paper introduce a method to connect high speed analog-digital converter (ADC212/100) with EPICS on Windows platform using LabVIEW. We use labVIEW to communicate with the converter, then use interface sub-VIs between LabVIEW and EPICS to access the EPICS IOC by Channel Access (CA). For the easy use graph programming language of LabVIEW, this method could shorten the develop period and reduce manpower cost. (authors)

  14. Experience with EPICS in a wide variety of applications

    International Nuclear Information System (INIS)

    Kraimer, M.R.; Clausen, M.; Lupton, W.; Watson, C.

    1997-01-01

    Currently more than 70 organizations have obtained permission to use the Experimental Physics and Industrial Control System (EPICS), a set of software packages for building real-time control systems. In this paper representatives from four of these sites discuss the reasons their sites chose EPICS, provide a brief discussion of their control system development, and discuss additional control system tools obtained elsewhere or developed locally

  15. Butterflies and Dragon-Eagles: Processing Epics from Southwest China

    Directory of Open Access Journals (Sweden)

    Mark Bender

    2012-03-01

    Full Text Available In the mountains of southwest China, epic narratives are part of the traditional performance-scapes of many ethnic minority cultures. In some cases locals participate in the preservation of oral or oral-connected epics from their respective areas. This article discusses the dynamics of acquiring and translating texts from two major ethnic minority groups in cooperation with local tradition-bearers, poets, and scholars.

  16. Experience with EPICS in a wide variety of applications

    Energy Technology Data Exchange (ETDEWEB)

    Kraimer, M.R. [Argonne National Lab., IL (United States); Clausen, M. [Deutsches Elektronen Synchrotron, Hamburg (Germany); Lupton, W. [W.M. Keck Observatory, Kamuela, HI (United States); Watson, C. [Thomas Jefferson National Accelerator Facility, Newport News, VA (United States)

    1997-08-01

    Currently more than 70 organizations have obtained permission to use the Experimental Physics and Industrial Control System (EPICS), a set of software packages for building real-time control systems. In this paper representatives from four of these sites discuss the reasons their sites chose EPICS, provide a brief discussion of their control system development, and discuss additional control system tools obtained elsewhere or developed locally.

  17. Portfolio of prospective clinical trials including brachytherapy: an analysis of the ClinicalTrials.gov database

    International Nuclear Information System (INIS)

    Cihoric, Nikola; Tsikkinis, Alexandros; Miguelez, Cristina Gutierrez; Strnad, Vratislav; Soldatovic, Ivan; Ghadjar, Pirus; Jeremic, Branislav; Dal Pra, Alan; Aebersold, Daniel M.; Lössl, Kristina

    2016-01-01

    To evaluate the current status of prospective interventional clinical trials that includes brachytherapy (BT) procedures. The records of 175,538 (100 %) clinical trials registered at ClinicalTrials.gov were downloaded on September 2014 and a database was established. Trials using BT as an intervention were identified for further analyses. The selected trials were manually categorized according to indication(s), BT source, applied dose rate, primary sponsor type, location, protocol initiator and funding source. We analyzed trials across 8 available trial protocol elements registered within the database. In total 245 clinical trials were identified, 147 with BT as primary investigated treatment modality and 98 that included BT as an optional treatment component or as part of the standard treatment. Academic centers were the most frequent protocol initiators in trials where BT was the primary investigational treatment modality (p < 0.01). High dose rate (HDR) BT was the most frequently investigated type of BT dose rate (46.3 %) followed by low dose rate (LDR) (42.0 %). Prostate was the most frequently investigated tumor entity in trials with BT as the primary treatment modality (40.1 %) followed by breast cancer (17.0 %). BT was rarely the primary investigated treatment modality for cervical cancer (6.8 %). Most clinical trials using BT are predominantly in early phases, investigator-initiated and with low accrual numbers. Current investigational activities that include BT mainly focus on prostate and breast cancers. Important questions concerning the optimal usage of BT will not be answered in the near future. The online version of this article (doi:10.1186/s13014-016-0624-8) contains supplementary material, which is available to authorized users

  18. Doing accelerator physics using SDDS, UNIX, and EPICS

    International Nuclear Information System (INIS)

    Borland, M.; Emery, L.; Sereno, N.

    1995-01-01

    The use of the SDDS (Self-Describing Data Sets) file protocol, together with the UNIX operating system and EPICS (Experimental Physics and Industrial Controls System), has proved powerful during the commissioning of the APS (Advanced Photon Source) accelerator complex. The SDDS file protocol has permitted a tool-oriented approach to developing applications, wherein generic programs axe written that function as part of multiple applications. While EPICS-specific tools were written for data collection, automated experiment execution, closed-loop control, and so forth, data processing and display axe done with the SDDS Toolkit. Experiments and data reduction axe implemented as UNIX shell scripts that coordinate the execution of EPICS specific tools and SDDS tools. Because of the power and generic nature of the individual tools and of the UNIX shell environment, automated experiments can be prepared and executed rapidly in response to unanticipated needs or new ideas. Examples are given of application of this methodology to beam motion characterization, beam-position-monitor offset measurements, and klystron characterization

  19. Clinical Trials

    Medline Plus

    Full Text Available ... part. Randomization Most clinical trials that have comparison groups use randomization. This involves assigning patients to different comparison groups by chance, rather than choice. This ...

  20. EPICS data archiver at SSRF beamlines

    International Nuclear Information System (INIS)

    Hu Zheng; Mi Qingru; Zheng Lifang; Li Zhong

    2014-01-01

    The control system of SSRF (Shanghai Synchrotron Radiation Facility) is based on EPICS (Experimental Physics and Industrial Control System). Operation data storage for synchrotron radiation facility is important for its status monitoring and analysis. At SSRF, operation data used to be index files recorded by traditional EPICS Channel Archiver. Nevertheless, index files are not suitable for long-term maintenance and difficult for data analysis. Now, RDB Channel Archiver and MySQL are used for SSRF beamline operation data archiving, so as to promote the data storage reliability and usability. By applying a new uploading mechanism to RDB Channel Archiver, its writing performance is improved. A web-based GUI (Graphics User Interface) is also developed to make it easier to access database. (authors)

  1. EPIC'S NEW REMOTE SENSING DATA AND INFORMATION TOOLS AVAILABLE FOR EPA CUSTOMERS

    Science.gov (United States)

    EPIC's New Remote Sensing Data and Information Tools Available for EPA Customers Donald Garofalo Environmental Photographic Interpretation Center (EPIC) Landscape Ecology Branch Environmental Sciences Division National Exposure Research Laboratory Several new too...

  2. Clinical Trials

    Medline Plus

    Full Text Available ... or treatment is having harmful effects. Food and Drug Administration In the United States, the Food and Drug Administration (FDA) provides oversight for clinical trials that ...

  3. Clinical Trials

    Medline Plus

    Full Text Available ... treatment is having harmful effects. Food and Drug Administration In the United States, the Food and Drug Administration (FDA) provides oversight for clinical trials that are ...

  4. Trial publication after registration in ClinicalTrials.Gov: a cross-sectional analysis.

    Directory of Open Access Journals (Sweden)

    Joseph S Ross

    2009-09-01

    Full Text Available ClinicalTrials.gov is a publicly accessible, Internet-based registry of clinical trials managed by the US National Library of Medicine that has the potential to address selective trial publication. Our objectives were to examine completeness of registration within ClinicalTrials.gov and to determine the extent and correlates of selective publication.We examined reporting of registration information among a cross-section of trials that had been registered at ClinicalTrials.gov after December 31, 1999 and updated as having been completed by June 8, 2007, excluding phase I trials. We then determined publication status among a random 10% subsample by searching MEDLINE using a systematic protocol, after excluding trials completed after December 31, 2005 to allow at least 2 y for publication following completion. Among the full sample of completed trials (n = 7,515, nearly 100% reported all data elements mandated by ClinicalTrials.gov, such as intervention and sponsorship. Optional data element reporting varied, with 53% reporting trial end date, 66% reporting primary outcome, and 87% reporting trial start date. Among the 10% subsample, less than half (311 of 677, 46% of trials were published, among which 96 (31% provided a citation within ClinicalTrials.gov of a publication describing trial results. Trials primarily sponsored by industry (40%, 144 of 357 were less likely to be published when compared with nonindustry/nongovernment sponsored trials (56%, 110 of 198; p<0.001, but there was no significant difference when compared with government sponsored trials (47%, 57 of 122; p = 0.22. Among trials that reported an end date, 75 of 123 (61% completed prior to 2004, 50 of 96 (52% completed during 2004, and 62 of 149 (42% completed during 2005 were published (p = 0.006.Reporting of optional data elements varied and publication rates among completed trials registered within ClinicalTrials.gov were low. Without greater attention to reporting of all data

  5. Clinical Trials

    Medline Plus

    Full Text Available ... and compare new treatments with other available treatments. Steps To Avoid Bias The researchers doing clinical trials take steps to avoid bias. "Bias" means that human choices ...

  6. Clinical Trials

    Medline Plus

    Full Text Available ... and evaluated to fill an important gap in information and education for parents, clinicians, researchers, children, and the general public. What to Expect During a clinical trial, ...

  7. Opioid detoxification : from controlled clinical trial to clinical practice

    NARCIS (Netherlands)

    Dijkstra, Boukje A G; De Jong, Cor A J; Wensing, Michel; Krabbe, Paul F M; van der Staak, Cees P F

    2010-01-01

    Controlled clinical trials have high internal validity but suffer from difficulties in external validity. This study evaluates the generalizability of the results of a controlled clinical trial on rapid detoxification in the everyday clinical practice of two addiction treatment centers. The results

  8. EPICS-QT based graphical user interface for accelerator control

    International Nuclear Information System (INIS)

    Basu, A.; Singh, S.K.; Rosily, Sherry; Bhagwat, P.V.

    2016-01-01

    Particle accelerators and many industrial complex systems, require a robust and efficient control for its proper operation to achieve required beam quality, safety of its sub component and all working personnel. This control is executed via a graphical user interface through which an operator interacts with the accelerator to achieve the desired state of the machine and its output. Experimental Physics and Industrial Control System (EPICS) is a widely used control system framework in the field of accelerator control. It acts as a middle layer between field devices and graphic user interface used by the operator. Field devices can also be made EPICS compliant by using EPICS based software in that. On the other hand Qt is a C++ framework which is widely used for creating very professional looking and user friendly graphical component. In Low Energy High Intensity Proton Accelerator (LEHIPA), which is the first stage of the three stage Accelerator Driven System (ADS) program taken by Bhabha Atomic Research Centre (BARC), it is decided that EPICS will be used for controlling the accelerator and Qt will be used for developing the various Graphic User Interface (GUI) for operation and diagnostics. This paper discuss the work carried out to achieve this goal in LEHIPA

  9. The KSTAR integrated control system based on EPICS

    International Nuclear Information System (INIS)

    Kim, K.H.; Ju, C.J.; Kim, M.K.; Park, M.K.; Choi, J.W.; Kyum, M.C.; Kwon, M.

    2006-01-01

    The Korea Superconducting Tokamak Advanced Research (KSTAR) control system will be developed with several subsystems, which consist of the central control system (e.g. plasma control, machine control, diagnostic control, time synchronization, and interlock systems) and local control systems for various subsystems. We are planning to connect the entire system with several networks, viz. a reflective-memory-based real-time network, an optical timing network, a gigabit Ethernet network for generic machine control, and a storage network. Then it will evolve into a network-based, distributed real-time control system. Thus, we have to consider the standard communication protocols among the subsystems and how to handle the various kinds of hardware in a homogeneous way. To satisfy these requirements, EPICS has been chosen for the KSTAR control. The EPICS framework provides network-based real-time distributed control, operating system independent programming tools, operator interface tools, archiving tools, and interface tools with other commercial and non-commercial software. The most important advantage of the use of the EPICS framework is in providing homogeneity of the system for the control system developer. The developer does not have to be concerned about the specifics of the local system, but can concentrate on the implementation of the control logic with EPICS tools. We will present the details of the integration issues and also will give a brief summary of the entire KSTAR control system from an integration point of view

  10. Centrally managed name resolution schemes for EPICS

    International Nuclear Information System (INIS)

    Jun, D.

    1997-01-01

    The Experimental Physics and Industrial Control System (EPICS) uses a broadcast method to locate resources and controls distributed across control servers. There are many advantages offered by using a centrally managed name resolution method, in which resources are located using a repository. The suitability of DCE Directory Service as a name resolution method is explored, and results from a study involving DCE are discussed. An alternative nameserver method developed and in use at the Thomas Jefferson national Accelerator Facility (Jefferson Lab) is described and results of integrating this new method with existing EPICS utilities presented. The various methods discussed in the paper are compared

  11. Clinical trials recruitment planning: A proposed framework from the Clinical Trials Transformation Initiative.

    Science.gov (United States)

    Huang, Grant D; Bull, Jonca; Johnston McKee, Kelly; Mahon, Elizabeth; Harper, Beth; Roberts, Jamie N

    2018-03-01

    Patient recruitment is widely recognized as a key determinant of success for clinical trials. Yet a substantial number of trials fail to reach recruitment goals-a situation that has important scientific, financial, ethical, and policy implications. Further, there are important effects on stakeholders who directly contribute to the trial including investigators, sponsors, and study participants. Despite efforts over multiple decades to identify and address barriers, recruitment challenges persist. To advance a more comprehensive approach to trial recruitment, the Clinical Trials Transformation Initiative (CTTI) convened a project team to examine the challenges and to issue actionable, evidence-based recommendations for improving recruitment planning that extend beyond common study-specific strategies. We describe our multi-stakeholder effort to develop a framework that delineates three areas essential to strategic recruitment planning efforts: (1) trial design and protocol development, (2) trial feasibility and site selection, and (3) communication. Our recommendations propose an upstream approach to recruitment planning that has the potential to produce greater impact and reduce downstream barriers. Additionally, we offer tools to help facilitate adoption of the recommendations. We hope that our framework and recommendations will serve as a guide for initial efforts in clinical trial recruitment planning irrespective of disease or intervention focus, provide a common basis for discussions in this area and generate targets for further analysis and continual improvement. Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.

  12. Clinical Trials

    Medline Plus

    Full Text Available ... and organizations also sponsor clinical trials. Examples include Government Agencies, such as the U.S. Departments of Defense and Veterans Affairs; private companies; universities; and nonprofit organizations. NIH Institutes and ...

  13. Clinical Trials

    Medline Plus

    Full Text Available ... new treatments in small groups of people for safety and side effects. Phase II clinical trials look at how well treatments work and further review these treatments for safety. Phase ...

  14. Clinical Trials

    Science.gov (United States)

    ... of Personal Stories Peers Celebrating Art Peers Celebrating Music Be Vocal Support Locator DBSA In-Person Support ... by participating in a clinical trial is to science first and to the patient second. More About ...

  15. Clinical Trials

    Medline Plus

    Full Text Available ... study explored whether the benefits of lowering high blood pressure in the elderly outweighed the risks. Other examples of clinical trials that test principles or strategies include studies that explore whether ...

  16. Clinical Trials

    Medline Plus

    Full Text Available ... medical centers and doctors' offices around the country. Benefits and Risks Possible Benefits Taking part in a clinical trial can have many benefits. For example, you may gain access to new ...

  17. Ethics of clinical trials in Nigeria.

    Science.gov (United States)

    Okonta, Patrick I

    2014-05-01

    The conduct of clinical trials for the development and licensing of drugs is a very important aspect of healthcare. Drug research, development and promotion have grown to a multi-billion dollar global business. Like all areas of human endeavour involving generation and control of huge financial resources, it could be subject to deviant behaviour, sharp business practices and unethical practices. The main objective of this review is to highlight potential ethical challenges in the conduct of clinical trials in Nigeria and outline ways in which these can be avoided. Current international and national regulatory and ethical guidelines are reviewed to illustrate the requirements for ethical conduct of clinical trials. Past experiences of unethical conduct of clinical trials especially in developing countries along with the increasing globalisation of research makes it imperative that all players should be aware of the ethical challenges in clinical trials and the benchmarks for ethical conduct of clinical research in Nigeria.

  18. Falsificationism and clinical trials.

    Science.gov (United States)

    Senn, S J

    1991-11-01

    The relevance of the philosophy of Sir Karl Popper to the planning, conduct and analysis of clinical trials is examined. It is shown that blinding and randomization can only be regarded as valuable for the purpose of refuting universal hypotheses. The purpose of inclusion criteria is also examined. It is concluded that a misplaced belief in induction is responsible for many false notions regarding clinical trials.

  19. Clinical Trials

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    Full Text Available Skip to main content U.S. Department of Health & Human Services Health Topics Health Topics A-Z Clinical Trials Publications and Resources Health Education and Awareness The Science Science Home Blood Disorders ...

  20. Clinical Trials

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

  1. Development of KOMAC Beam Monitoring System Using EPICS

    Energy Technology Data Exchange (ETDEWEB)

    Song, Young-Gi; Yun, Sang-Pil; Kim, Han-Sung; Kwon, Hyeok-Jung; Cho, Yong-Sub [Korea Atomic Energy Research Institute, Daejeon (Korea, Republic of)

    2014-10-15

    The beam loss signals must be digitized and the sampling has to be synchronized to a reference signal which is an external trigger for beam operation. The digitized data must be accessible by the Experimental Physics and Industrial Control System (EPICS)-based control system, which manages the whole accelerator control. In order to satisfy the requirement, an Input /Output Controller (IOC), which runs Linux on a CPU module with PCI express based Analog to Digital Converter (ADC) modules, has been adopted. An associated linux driver and EPICS device support module also have been developed. The IOC meets the requirements and the development and maintenance of the software for the IOC is considerably efficient. The data acquisition system running EPICS will be used in increasing phase of KOrea Multi-purpose Accelerator Complex (KOMAC) beam power. The beam monitoring system integrates BLM and BPM signals into control system and offers real-time data to operators. The IOC, which is implemented with Linux and PCI driver, has supported data acquisition as a very flexible solution.

  2. Development of KOMAC Beam Monitoring System Using EPICS

    International Nuclear Information System (INIS)

    Song, Young-Gi; Yun, Sang-Pil; Kim, Han-Sung; Kwon, Hyeok-Jung; Cho, Yong-Sub

    2014-01-01

    The beam loss signals must be digitized and the sampling has to be synchronized to a reference signal which is an external trigger for beam operation. The digitized data must be accessible by the Experimental Physics and Industrial Control System (EPICS)-based control system, which manages the whole accelerator control. In order to satisfy the requirement, an Input /Output Controller (IOC), which runs Linux on a CPU module with PCI express based Analog to Digital Converter (ADC) modules, has been adopted. An associated linux driver and EPICS device support module also have been developed. The IOC meets the requirements and the development and maintenance of the software for the IOC is considerably efficient. The data acquisition system running EPICS will be used in increasing phase of KOrea Multi-purpose Accelerator Complex (KOMAC) beam power. The beam monitoring system integrates BLM and BPM signals into control system and offers real-time data to operators. The IOC, which is implemented with Linux and PCI driver, has supported data acquisition as a very flexible solution

  3. Transparency in ovarian cancer clinical trial results: ClinicalTrials.gov versus PubMed, Embase and Google scholar.

    Science.gov (United States)

    Roberto, Anna; Radrezza, Silvia; Mosconi, Paola

    2018-04-10

    In recent years the question of the lack of transparency in clinical research has been debated by clinicians, researchers, citizens and their representatives, authors and publishers. This is particularly important for infrequent cancers such as ovarian cancer, where treatment still gives disappointing results in the majority of cases. Our aim was to assess the availability to the public of results in ClinicalTrials.gov, and the frequency of non-publication of results in ClinicalTrials.gov and in PubMed, Embase and Google Scholar. We collected all trials on ovarian cancer identified as "completed status" in the ClinicalTrials.gov registry on 17 January 2017. We checked the availability of the results in ClinicalTrials.gov and systematically identified published manuscripts on results. Out of 2725 trials on ovarian cancer identified, 752 were classified as "completed status". In those closed between 2008 and 2015, excluding phase I, the frequency of results in ClinicalTrials.gov was 35%. Of the 752 completed studies the frequency of published results in PubMed, Embase or Google Scholar ranged from 57.9% to 69.7% in the last years. These findings show a lack of transparency and credibility of research. Citizens or patients' representatives, with the medical community, should continuously support initiatives to improve the publication and dissemination of clinical study results.

  4. Clinical Trials

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    Full Text Available Skip to main content U.S. Department of Health & Human Services Health Topics Health Topics A-Z Clinical Trials Publications and Resources Health Education and Awareness The Science Science Home Blood Disorders and ...

  5. Clinical outcomes in clinical trials of anti-HIV treatment

    DEFF Research Database (Denmark)

    Reekie, J; Mocroft, A; J, Neaton

    2007-01-01

    Since the introduction of combination antiretroviral therapy, there has been a decrease in both AIDS-defining illnesses and deaths. This decrease meant that performing clinical trials with clinical outcomes in HIV infection became more time consuming and hence costly. Improved understanding...... the infection, so when treatment is started it is currently a lifelong commitment. Is it reasonable then that guidelines are based almost completely on short-term randomized trials and observational studies of surrogate markers, or is there still a need for trials with clinical outcomes?...

  6. The CEBAF accelerator control system: migrating from a TACL to an EPICS based system

    International Nuclear Information System (INIS)

    Watson, W.A. III; Barker, David; Bickley, Matthew; Gupta, Pratik; Johnson, R.P.

    1994-01-01

    CEBAF is in the process of migrating its accelerator and experimental hall control systems to one based upon EPICS, a control system toolkit developed by a collaboration among several DOE laboratories in the US. The new system design interfaces existing CAMAC hardware via a CAMAC serial highway to VME-based I/O controllers running the EPICS software; future additions and upgrades will for the most part go directly into VME. The decision to use EPICS followed difficulties in scaling the CEBAF-developed TACL system to full machine operation. TACL and EPICS share many design concepts, facilitating the conversion of software from one toolkit to the other. In particular, each supports graphical entry of algorithms built up from modular code, graphical displays with a display editor, and a client-server architecture with name-based I/O. During the migration, TACL and EPICS will interoperate through a socket-based I/O gateway. As part of a collaboration with other laboratories, CEBAF will add relational database support for system management and high level applications support. Initial experience with EPICS is presented, along with a plan for the full migration which is expected to be finished next year. ((orig.))

  7. Clinical Trials

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    Full Text Available ... A-Z Clinical Trials Publications and Resources Health Education and Awareness The Science Science Home Blood Disorders ... to fill an important gap in information and education for parents, clinicians, researchers, children, and the general ...

  8. Clinical Trials

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    Full Text Available ... issues arise. Participation and Eligibility Each clinical trial defines who is eligible to take part in the ... the strategy or treatment is having harmful effects. Food and Drug Administration In the United States, the ...

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    Full Text Available ... successfully developed and evaluated to fill an important gap in information and education for parents, clinicians, researchers, ... gathered can help others and add to scientific knowledge. People who take part in clinical trials are ...

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    Full Text Available ... Usually, a computer program makes the group assignments. Masking The term "masking" refers to not telling the clinical trial participants which treatment they're getting. Masking, or "blinding," helps avoid bias. For this reason, ...

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    Full Text Available ... gathered can help others and add to scientific knowledge. People who take part in clinical trials are vital to the process of improving medical care. Many people volunteer because they want to help others. ...

  13. Clinical Trials

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    Full Text Available ... materials, and offer advice on research-related issues. Data Safety Monitoring Board Every National Institutes of Health ( ... III clinical trial is required to have a Data and Safety Monitoring Board (DSMB). This board consists ...

  14. Clinical Trials

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    Full Text Available ... patients. Usually, a computer program makes the group assignments. Masking The term "masking" refers to not telling ... questions to ask your doctor and the research staff, go to "How Do Clinical Trials Protect Participants?" ...

  15. Clinical Trials

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    Full Text Available ... results. Clinical trials are one of the final stages of a long and careful research process. The ... a patient's age and gender, the type and stage of disease, and whether the patient has had ...

  16. Clinical Trials

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    Full Text Available ... strict scientific standards. These standards protect patients and help produce reliable study results. Clinical trials are one ... are important because they advance medical knowledge and help improve patient care. Sponsorship and Funding The National ...

  17. Clinical Trials

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    Full Text Available ... patients to find out whether a new approach causes any harm. In later phases of clinical trials, ... device improves patient outcomes; offers no benefit; or causes unexpected harm All of these results are important ...

  18. Clinical Trials

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    Full Text Available ... small groups of people for safety and side effects. Phase II clinical trials look at how well ... confirm how well treatments work, further examine side effects, and compare new treatments with other available treatments. ...

  19. Clinical Trials

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    Full Text Available ... studies. View funding information for clinical trials optimization . Building 31 31 Center Drive Bethesda, MD 20892 Learn ... and Usage No FEAR Act Grants and Funding Building 31 31 Center Drive Bethesda, MD 20892 Learn ...

  20. Clinical Trials

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    Full Text Available ... questions to ask your doctor and the research staff, go to "How Do Clinical Trials Protect Participants?" ... in Bethesda, Maryland. The physicians, nurses, scientists and staff of the NHLBI encourage you to explore NIH ...

  1. Clinical Trials

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    Full Text Available ... to Expect During a clinical trial, doctors, nurses, social workers, and other health care providers might be ... the new approach. You also will have the support of a team of health care providers, who ...

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    Full Text Available ... harm. In later phases of clinical trials, researchers learn more about the new approach's risks and benefits. ... explore whether surgery or other medical treatments produce better results for certain illnesses or groups of people; ...

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    Full Text Available ... offer a variety of funding mechanisms tailored to planning and conducting clinical trials at all phases, including ... Center for Health Information Email Alerts Jobs and Careers Site Index About NHLBI National Institute of Health ...

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    Full Text Available ... clinical care of children, more studies are needed focusing on children's health with the goal to develop ... study? How might this trial affect my daily life? Will I have to be in the hospital? ...

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    Full Text Available ... work best for certain illnesses or groups of people. Clinical trials produce the best data available for ... or animals doesn't always work well in people. Thus, research in humans is needed. For safety ...

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    Full Text Available ... women and that are ethnically diverse. Children also need clinical trials that focus on them, as medical ... often differ for children. For example, children may need lower doses of certain medicines or smaller medical ...

  7. Clinical Trials

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    Full Text Available ... NHLBI About NHLBI Home Mission and Strategic Vision Leadership Scientific Divisions Operations and Administration Advisory Committees Budget ... always, parents must give legal consent for their child to take part in a clinical trial. When ...

  8. Clinical Trials

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    Full Text Available ... Events About NHLBI About NHLBI Home Mission and Strategic Vision Leadership Scientific Divisions Operations and Administration Advisory ... offer a variety of funding mechanisms tailored to planning and conducting clinical trials at all phases, including ...

  9. Clinical Trials

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    Full Text Available ... records can quickly show this information if safety issues arise. Participation and Eligibility Each clinical trial defines ... and materials, and offer advice on research-related issues. Data Safety Monitoring Board Every National Institutes of ...

  10. Clinical Trials

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    Full Text Available ... care providers might be part of your treatment team. They will monitor your health closely. You may ... taking part in a clinical trial. Your treatment team also may ask you to do other tasks. ...

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    Full Text Available ... Clinical Trials Publications and Resources Health Education and Awareness The Science Science Home Blood Disorders and Blood ... these results are important because they advance medical knowledge and help improve patient care. Sponsorship and Funding ...

  12. Clinical Trials

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    Full Text Available ... from other clinical trials show what doesn't work or may cause harm. For example, the NHLBI Women's Health Initiative tested whether hormone therapy (HT) reduced the risk of heart disease in postmenopausal women. ( ...

  13. Clinical Trials

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    Full Text Available ... always, parents must give legal consent for their child to take part in a clinical trial. When ... minimal, both parents must give permission for their child to enroll. Also, children aged 7 and older ...

  14. EPICS: operating system independent device/driver support

    International Nuclear Information System (INIS)

    Kraimer, M.R.

    2003-01-01

    Originally EPICS input/output controllers (IOCs) were only supported on VME-based systems running the vxWorks operating system. Now IOCs are supported on many systems: vxWorks, RTEMS, Solaris, HPUX, Linux, WIN32, and Darwin. A challenge is to provide operating-system-independent device and driver support. This paper presents some techniques for providing such support. EPICS (Experimental Physics and Industrial Control System) is a set of software tools, libraries, and applications developed collaboratively and used worldwide to create distributed, real-time control systems for scientific instruments such as particle accelerators, telescopes, and other large scientific experiments. An important component of all EPICS-based control systems is a collection of input/output controllers (IOCs). An IOC has three primary components: (1) a real-time database; (2) channel access, which provides network access to the database; and (3) device/driver support for interfacing to equipment. This paper describes some projects related to providing device/driver support on non-vxWorks systems. In order to support IOCs on platforms other than vxWorks, operating-system-independent (OSI) application program interfaces (APIs) were defined for threads, semaphores, timers, etc. Providing support for a new platform consists of providing an operating-system-dependent implementation of the OSI APIs.

  15. On Collecting and Publishing the Albanian Oral Epic

    Directory of Open Access Journals (Sweden)

    Arbnora Dushi

    2014-05-01

    Full Text Available The aim of this paper is to examine how the Albanian epic known as the ‘Cycle of the Frontier Warriors’ has been presented in Albanian folklore collections. I will examine seven written versions of the song ‘The Wedding of Ali Bajraktari’, which belongs to this epic cycle. The ‘Cycle of the Frontier Warriors’, has been an object of collection since the beginning of the twentieth century. There are now dozens of volumes published, but the studies published to date concentrate on historical, thematic and comparative rather than contextual and textual issues.

  16. Clinical Trials

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    Full Text Available ... Clinical Trials Publications and Resources Health Education and Awareness The Science Science Home Blood Disorders and Blood ... of estrogen and progestin, the risk of breast cancer also increased. As a result, the U.S. Food ...

  17. Clinical Trials

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    Full Text Available ... organizations also sponsor clinical trials. Examples include Government Agencies, such as the U.S. Departments of Defense and ... how you feel. Some people will need to travel or stay in hospitals to take part in ...

  18. Clinical Trials

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    Full Text Available ... sponsor clinical trials. Examples include Government Agencies, such as the U.S. Departments of Defense and Veterans Affairs; ... age and frequency for doing screening tests, such as mammography; and compare two or more screening tests ...

  19. Clinical Trials

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    Full Text Available ... as the U.S. Departments of Defense and Veterans Affairs; private companies; universities; and nonprofit organizations. NIH Institutes ... for parents, clinicians, researchers, children, and the general public. What to Expect During a clinical trial, doctors, ...

  20. Clinical Trials

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    Full Text Available ... and organizations also sponsor clinical trials. Examples include Government Agencies, such as the U.S. Departments of Defense ... FOIA) Accessibility Copyright and Usage No FEAR Act Grants and Funding Building 31 31 Center Drive Bethesda, ...

  1. Type 1 Diabetes TrialNet--an international collaborative clinical trials network.

    Science.gov (United States)

    Skyler, Jay S; Greenbaum, Carla J; Lachin, John M; Leschek, Ellen; Rafkin-Mervis, Lisa; Savage, Peter; Spain, Lisa

    2008-12-01

    Type 1 Diabetes TrialNet is an international consortium of clinical research centers aimed at the prevention or delay of type 1 diabetes (T1D). The fundamental goal of TrialNet is to counter the T1D disease process by immune modulation and/or enhancement of beta cell proliferation and regeneration. To achieve this goal, TrialNet researchers are working to better understand the natural history of the disease, to identify persons at risk, and to clinically evaluate novel therapies that balance potential risks and benefits. The particular focus is on studies of preventive measures. In addition, TrialNet evaluates therapies in individuals with newly diagnosed T1D with preserved beta cell function to help determine the risk/benefit profile and gain an initial assessment of potential efficacy in preservation of beta cell function, so that promising agents can be studied in prevention trials. In addition, TrialNet evaluates methodologies that enhance the conduct of its clinical trials, which includes tests of outcome assessment methodology, the evaluation of surrogate markers, and mechanistic studies laying the foundation for future clinical trials.

  2. Clinical outcomes in clinical trials of anti-HIV treatment

    DEFF Research Database (Denmark)

    Reekie, J; Mocroft, A; J, Neaton

    2007-01-01

    Since the introduction of combination antiretroviral therapy, there has been a decrease in both AIDS-defining illnesses and deaths. This decrease meant that performing clinical trials with clinical outcomes in HIV infection became more time consuming and hence costly. Improved understanding...... and knowledge of HIV led to short-term trials using surrogate outcomes such as viral load and CD4 count. This established a faster drug approval process that complimented the rapid need to evaluate and provide access to drugs based on short-term trials. However, no treatment has yet been found that eradicates...... the infection, so when treatment is started it is currently a lifelong commitment. Is it reasonable then that guidelines are based almost completely on short-term randomized trials and observational studies of surrogate markers, or is there still a need for trials with clinical outcomes?...

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

    OpenAIRE

    C. A. Caramori

    2007-01-01

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

  4. Hepatitis C: Clinical Trials

    Science.gov (United States)

    ... and Public Home » Hepatitis C » Treatment Decisions Viral Hepatitis Menu Menu Viral Hepatitis Viral Hepatitis Home For ... can I find out about participating in a hepatitis C clinical trial? Many trials are being conducted ...

  5. Clinical Trials

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    Full Text Available Skip to main content U.S. Department of Health & Human Services Health Topics Health Topics A-Z Clinical Trials Publications and Resources Health Education and Awareness The Science Science Home Blood Disorders and Blood Safety Sleep ...

  6. Clinical Trials

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    Full Text Available ... as gene therapy) or vulnerable patients (such as children). A DSMB's role is to review data from a clinical trial for safety problems or differences in results among different groups. The DSMB also reviews research results ...

  7. Clinical Trials

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    Full Text Available ... final stages of a long and careful research process. The process often begins in a laboratory (lab), where scientists ... part in clinical trials are vital to the process of improving medical care. Many people volunteer because ...

  8. Clinical Trials

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    Full Text Available ... combination of estrogen and progestin, the risk of breast cancer also increased. As a result, the U.S. Food ... to test new approaches to prevention, diagnosis, or screening. In the past, clinical trial participants often were ...

  9. Inherited Retinal Degenerative Clinical Trial Network

    Science.gov (United States)

    2009-10-01

    clinical efforts that will impact the NEER network going forward and laid the ground work for the CTECs to participate in ongoing clinical trials for...Clinical Implications: • How will the proposed clinical trial have a significant impact on disease outcome? 34 • How will the clinical trial offer...was 0 041U>< for pat<t!nts NPtS and <H08, 0 4 1ux !01 Ct 110, 1nd 10.0 lux f01 < H13 OJ)Ilo •her on~tion are indiuttd AhtrNtor19 stimuli Wl’f1! pres

  10. Methodology Series Module 4: Clinical Trials.

    Science.gov (United States)

    Setia, Maninder Singh

    2016-01-01

    In a clinical trial, study participants are (usually) divided into two groups. One group is then given the intervention and the other group is not given the intervention (or may be given some existing standard of care). We compare the outcomes in these groups and assess the role of intervention. Some of the trial designs are (1) parallel study design, (2) cross-over design, (3) factorial design, and (4) withdrawal group design. The trials can also be classified according to the stage of the trial (Phase I, II, III, and IV) or the nature of the trial (efficacy vs. effectiveness trials, superiority vs. equivalence trials). Randomization is one of the procedures by which we allocate different interventions to the groups. It ensures that all the included participants have a specified probability of being allocated to either of the groups in the intervention study. If participants and the investigator know about the allocation of the intervention, then it is called an "open trial." However, many of the trials are not open - they are blinded. Blinding is useful to minimize bias in clinical trials. The researcher should familiarize themselves with the CONSORT statement and the appropriate Clinical Trials Registry of India.

  11. Clinical Trials

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    Full Text Available ... protect patients and help produce reliable study results. Clinical trials are one of the final stages of a long and careful research process. The process often begins in a laboratory (lab), where scientists first develop and test new ...

  12. Clinical Trials

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    Full Text Available ... to main content U.S. Department of Health & Human Services Health Topics Health Topics A-Z Clinical Trials Publications and Resources Health Education and Awareness The Science Science Home Blood Disorders and Blood Safety Sleep Science and ...

  13. Clinical Trials

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    Full Text Available ... safe a treatment is or how well it works. Children (aged 18 and younger) get special protection as research subjects. Almost always, parents must give legal consent for their child to take part in a clinical trial. When ...

  14. Clinical Trials

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    Full Text Available ... Science Science Home Blood Disorders and Blood Safety Sleep Science and Sleep Disorders Lung Diseases Heart and Vascular Diseases Precision ... women and that are ethnically diverse. Children also need clinical trials that focus on them, as medical ...

  15. Clinical Trials

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    Full Text Available ... 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 with small groups of patients to find out whether a ...

  16. Best clinical trials reported in 2010.

    Science.gov (United States)

    Garner, John B; Grayburn, Paul A; Yancy, Clyde W

    2011-07-01

    Each year, a number of clinical trials emerge with data sufficient to change clinical practice. Determining which findings will result in practice change and which will provide only incremental benefit can be a dilemma for clinicians. The authors review selected clinical trials reported in 2010 in journals, at society meetings, and at conferences, focusing on those studies that have the potential to change clinical practice. This review offers 3 separate means of analysis: an abbreviated text summary, organized by subject area; a comprehensive table of relevant clinical trials that provides a schematic review of the hypotheses, interventions, methods, primary end points, results, and implications; and a complete bibliography for further reading as warranted. It is hoped that this compilation of relevant clinical trials and their important findings released in 2010 will be of benefit in the everyday practice of cardiovascular medicine. Copyright © 2011 Elsevier Inc. All rights reserved.

  17. EPICS: A control system software co-development success story

    International Nuclear Information System (INIS)

    Knott, M.; Gurd, D.; Lewis, S.; Thuot, M.

    1993-01-01

    The Experimental Physics and Industrial Control Systems (EPICS) is the result of a software sharing and co-development effort of major importance now underway. The initial two participants, LANL and ANL, have now been joined by three other labs, and an earlier version of the software has been transferred to three commercial firms and is currently undergoing separate development. The reasons for EPICS's success may be useful to enumerate and explain and the desire and prospects for its continued development are certainly worth examining

  18. Extrasolar Planetary Imaging Coronagraph (EPIC): visible nulling cornagraph testbed results

    Science.gov (United States)

    Lyon, Richard G.; Clampin, Mark; Melnick, Gary; Tolls, Volker; Woodruff, Robert; Vasudevan, Gopal

    2008-07-01

    The Extrasolar Planetary Imaging Coronagraph (EPIC) is a NASA Astrophysics Strategic Mission Concept under study for the upcoming Exoplanet Probe. EPIC's mission would be to image and characterize extrasolar giant planets, and potential super-Earths, in orbits with semi-major axes between 2 and 10 AU. EPIC will provide insights into the physical nature of a variety of planets in other solar systems complimenting radial velocity (RV) and astrometric planet searches. It will detect and characterize the atmospheres of planets identified by radial velocity surveys and potentially some transits, determine orbital inclinations and masses, characterize the atmospheres of gas giants around A and F stars, observed the inner spatial structure and colors of inner Spitzer selected debris disks. EPIC would be launched into a heliocentric Earth trailing drift-away orbit, with a 3-year mission lifetime (5 year goal) and will revisit planets at least three times. The starlight suppression approach consists of a visible nulling coronagraph (VNC) that enables high order starlight suppression in broadband light. To demonstrate the VNC approach and advance it's technology readiness the NASA/Goddard Space Flight Center and Lockheed-Martin have developed a laboratory VNC and have demonstrated white light nulling. We will discuss our ongoing VNC work and show the latest results from the VNC testbed.

  19. EPICS IOC module development and implementation for the ISTTOK machine subsystem operation and control

    Energy Technology Data Exchange (ETDEWEB)

    Carvalho, Paulo, E-mail: pricardofc@ipfn.ist.utl.pt [Associacao EURATOM/IST, Instituto de Plasmas e Fusao Nuclear-Laboratorio Associado, Instituto Superior Tecnico, P-1049-001 Lisboa (Portugal); Duarte, Andre; Pereira, Tiago; Carvalho, Bernardo; Sousa, Jorge; Fernandes, Horacio [Associacao EURATOM/IST, Instituto de Plasmas e Fusao Nuclear-Laboratorio Associado, Instituto Superior Tecnico, P-1049-001 Lisboa (Portugal); Correia, Carlos [Grupo de Electronica e Instrumentacao-Centro de Instrumentacao, Departamento de Fisica, Universidade de Coimbra, P-3004-516 Coimbra (Portugal); Goncalves, Bruno; Varandas, Carlos [Associacao EURATOM/IST, Instituto de Plasmas e Fusao Nuclear-Laboratorio Associado, Instituto Superior Tecnico, P-1049-001 Lisboa (Portugal)

    2011-10-15

    This paper presents a developed, tested and integrated EPICS IOC (I/O controller) module solution for the ISTTOK tokamak machine operation and control for the vacuum and gas injection systems. The work is organized in two software layers which communicate through a serial RS-232 communication protocol. The first software layer is an EPICS IOC module running as a computer server application capable of receiving requests from remote or local clients providing driver interface to the system by forwarding requested commands and receiving system and control operation status. The second software layer is the firmware running in Microchip dsPIC microcontroller modules which performs the interface from RS-232 optical fiber serial protocol to EPICS IOC module. The dsPIC module communicates to the ISTTOK tokamak sensors and actuators via RS-485 and is programmed with a new protocol developed for this purpose that allows EPICS IOC module command sending/receiving, machine operation control and monitoring and system status information. Communication between EPICS IOC module and clients is achieved via a TCP/IP and UDP protocol referred as Channel Access. In addition, the EPICS IOC module provides user client applications access allowing operators to perform remote or local monitoring, operation and control.

  20. Spine device clinical trials: design and sponsorship.

    Science.gov (United States)

    Cher, Daniel J; Capobianco, Robyn A

    2015-05-01

    Multicenter prospective randomized clinical trials represent the best evidence to support the safety and effectiveness of medical devices. Industry sponsorship of multicenter clinical trials is purported to lead to bias. To determine what proportion of spine device-related trials are industry-sponsored and the effect of industry sponsorship on trial design. Analysis of data from a publicly available clinical trials database. Clinical trials of spine devices registered on ClinicalTrials.gov, a publicly accessible trial database, were evaluated in terms of design, number and location of study centers, and sample size. The relationship between trial design characteristics and study sponsorship was evaluated using logistic regression and general linear models. One thousand six hundred thrity-eight studies were retrieved from ClinicalTrials.gov using the search term "spine." Of the 367 trials that focused on spine surgery, 200 (54.5%) specifically studied devices for spine surgery and 167 (45.5%) focused on other issues related to spine surgery. Compared with nondevice trials, device trials were far more likely to be sponsored by the industry (74% vs. 22.2%, odds ratio (OR) 9.9 [95% confidence interval 6.1-16.3]). Industry-sponsored device trials were more likely multicenter (80% vs. 29%, OR 9.8 [4.8-21.1]) and had approximately four times as many participating study centers (pdevices not sponsored by the industry. Most device-related spine research is industry-sponsored. Multicenter trials are more likely to be industry-sponsored. These findings suggest that previously published studies showing larger effect sizes in industry-sponsored vs. nonindustry-sponsored studies may be biased as a result of failure to take into account the marked differences in design and purpose. Copyright © 2015 Elsevier Inc. All rights reserved.

  1. Clinical Trials

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    Full Text Available ... an important gap in information and education for parents, clinicians, researchers, children, and the general public. What to Expect During a clinical trial, doctors, nurses, social workers, and other health care providers might be part of your treatment team. ...

  2. Development of EPICS based beam-line experimental control employing motor controller for precision positioning

    International Nuclear Information System (INIS)

    Tuli, Anupriya; Jain, Rajiv; Vora, H.S.

    2015-01-01

    In a Synchrotron Radiation Source the beamline experiments are carried out in radiation prone environment, inside the hutch, which demands to conduct experiments remotely. These experiments involves instrument control and data acquisition from various devices. Another factor which attributes to system complexity is precise positioning of sample and placement of detectors. A large number of stepper motors are engaged for achieving the required precision positioning. This work is a result of development of Experimental Physics and Industrial Control System (EPICS) based control system to interface a stepper motor controller developed indigenously by Laser Electronics Support Division of RRCAT. EPICS is an internationally accepted open source software environment which follows toolkit approach and standard model paradigm. The operator interface for the control system software was implemented using CSS BOY. The system was successfully tested for Ethernet based remote access. The developed control software comprises of an OPI and alarm handler (EPICS ALH). Both OPI and ALH are linked with PV's defined in database files. The development process resulted into a set of EPICS based commands for controlling stepper motor. These commands are independent of operator interface, i.e. stepper motor can be controlled by using these set of commands directly on EPICS prompt. This command set is illustrated in the above table. EPICS Alarm Handler was also tested independently by running these commands on EPIC prompt. If not using ALH, operator can read the alarm status of a PV using 'SEVR' and 'STAT' attributes. (author)

  3. Reducing therapeutic misconception: A randomized intervention trial in hypothetical clinical trials.

    Directory of Open Access Journals (Sweden)

    Paul P Christopher

    Full Text Available Participants in clinical trials frequently fail to appreciate key differences between research and clinical care. This phenomenon, known as therapeutic misconception, undermines informed consent to clinical research, but to date there have been no effective interventions to reduce it and concerns have been expressed that to do so might impede recruitment. We determined whether a scientific reframing intervention reduces therapeutic misconception without significantly reducing willingness to participate in hypothetical clinical trials.This prospective randomized trial was conducted from 2015 to 2016 to test the efficacy of an informed consent intervention based on scientific reframing compared to a traditional informed consent procedure (control in reducing therapeutic misconception among patients considering enrollment in hypothetical clinical trials modeled on real-world studies for one of five disease categories. Patients with diabetes mellitus, hypertension, coronary artery disease, head/neck cancer, breast cancer, and major depression were recruited from medical clinics and a clinical research volunteer database. The primary outcomes were therapeutic misconception, as measured by a validated, ten-item Therapeutic Misconception Scale (range = 10-50, and willingness to participate in the clinical trial.154 participants completed the study (age range, 23-87 years; 92.3% white, 56.5% female; 74 (48.1% had been randomized to receive the experimental intervention. Therapeutic misconception was significantly lower (p = 0.004 in the scientific reframing group (26.4, 95% CI [23.7 to 29.1] compared to the control group (30.9, 95% CI [28.4 to 33.5], and remained so after controlling for education (p = 0.017. Willingness to participate in the hypothetical trial was not significantly different (p = 0.603 between intervention (52.1%, 95% CI [40.2% to 62.4%] and control (56.3%, 95% CI [45.3% to 66.6%] groups.An enhanced educational intervention augmenting

  4. A data grid for imaging-based clinical trials

    Science.gov (United States)

    Zhou, Zheng; Chao, Sander S.; Lee, Jasper; Liu, Brent; Documet, Jorge; Huang, H. K.

    2007-03-01

    Clinical trials play a crucial role in testing new drugs or devices in modern medicine. Medical imaging has also become an important tool in clinical trials because images provide a unique and fast diagnosis with visual observation and quantitative assessment. A typical imaging-based clinical trial consists of: 1) A well-defined rigorous clinical trial protocol, 2) a radiology core that has a quality control mechanism, a biostatistics component, and a server for storing and distributing data and analysis results; and 3) many field sites that generate and send image studies to the radiology core. As the number of clinical trials increases, it becomes a challenge for a radiology core servicing multiple trials to have a server robust enough to administrate and quickly distribute information to participating radiologists/clinicians worldwide. The Data Grid can satisfy the aforementioned requirements of imaging based clinical trials. In this paper, we present a Data Grid architecture for imaging-based clinical trials. A Data Grid prototype has been implemented in the Image Processing and Informatics (IPI) Laboratory at the University of Southern California to test and evaluate performance in storing trial images and analysis results for a clinical trial. The implementation methodology and evaluation protocol of the Data Grid are presented.

  5. Methodology series module 4: Clinical trials

    Directory of Open Access Journals (Sweden)

    Maninder Singh Setia

    2016-01-01

    Full Text Available In a clinical trial, study participants are (usually divided into two groups. One group is then given the intervention and the other group is not given the intervention (or may be given some existing standard of care. We compare the outcomes in these groups and assess the role of intervention. Some of the trial designs are (1 parallel study design, (2 cross-over design, (3 factorial design, and (4 withdrawal group design. The trials can also be classified according to the stage of the trial (Phase I, II, III, and IV or the nature of the trial (efficacy vs. effectiveness trials, superiority vs. equivalence trials. Randomization is one of the procedures by which we allocate different interventions to the groups. It ensures that all the included participants have a specified probability of being allocated to either of the groups in the intervention study. If participants and the investigator know about the allocation of the intervention, then it is called an "open trial." However, many of the trials are not open - they are blinded. Blinding is useful to minimize bias in clinical trials. The researcher should familiarize themselves with the CONSORT statement and the appropriate Clinical Trials Registry of India.

  6. Textbook of clinical trials

    National Research Council Canada - National Science Library

    Day, Simon; Machin, David; Green, Sylvan B

    2006-01-01

    ... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xix INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 1 The Development of Clinical Trials Simon...

  7. Clinical Trials

    Medline Plus

    Full Text Available ... patient has had certain treatments or has other health problems. Eligibility criteria ensure that new approaches are tested ... public. What to Expect During a clinical trial, doctors, nurses, social workers, and other health care providers might be part of your treatment ...

  8. EPICS: Channel Access security design

    International Nuclear Information System (INIS)

    Kraimer, M.; Hill, J.

    1994-05-01

    This document presents the design for implementing the requirements specified in: EPICS -- Channel Access Security -- functional requirements, Ned. D. Arnold, 03/09/92. Use of the access security system is described along with a summary of the functional requirements. The programmer's interface is given. Security protocol is described and finally aids for reading the access security code are provided

  9. HIV/AIDS Clinical Trials Fact Sheet

    Science.gov (United States)

    ... AIDS Drugs Clinical Trials Apps skip to content HIV Overview Home Understanding HIV/AIDS Fact Sheets HIV/ ... 4 p.m. ET) Send us an email HIV/AIDS Clinical Trials Last Reviewed: August 25, 2017 ...

  10. Continuity with Creole Epic and Innovation in the «History of New Mexico», 1610

    Directory of Open Access Journals (Sweden)

    Pedro Cebollero

    2017-11-01

    Full Text Available This is an introductory study to Gaspar de Villagrá’s History of New Mexico (1610 in the context of the Cortés epic cycle tradition. The concept of «epic continuity» is utilized in order to better understand how the poem adheres to epic tradition at the same time that it goes through formal changes needed for its renovation. Part of the renovation is the inclusion of prose as a legal defense strategy, and its use as a vehicle for the struggles of Mexican Creoles. It is proposed that this poem belongs in a Frontier Creole epic sub-cycle.

  11. The EPIC nutrient database project (ENDB): a first attempt to standardize nutrient databases across the 10 European countries participating in the EPIC study

    DEFF Research Database (Denmark)

    Slimani, N.; Deharveng, G.; Unwin, I.

    2007-01-01

    because there is currently no European reference NDB available. Design: A large network involving national compilers, nutritionists and experts on food chemistry and computer science was set up for the 'EPIC Nutrient DataBase' ( ENDB) project. A total of 550-1500 foods derived from about 37 000...... standardized EPIC 24-h dietary recalls (24-HDRS) were matched as closely as possible to foods available in the 10 national NDBs. The resulting national data sets ( NDS) were then successively documented, standardized and evaluated according to common guidelines and using a DataBase Management System...

  12. Perceived barriers to pediatrician and family practitioner participation in pediatric clinical trials: Findings from the Clinical Trials Transformation Initiative.

    Science.gov (United States)

    Greenberg, Rachel G; Corneli, Amy; Bradley, John; Farley, John; Jafri, Hasan S; Lin, Li; Nambiar, Sumathi; Noel, Gary J; Wheeler, Chris; Tiernan, Rosemary; Smith, P Brian; Roberts, Jamie; Benjamin, Daniel K

    2018-03-01

    Despite legislation to stimulate pediatric drug development through clinical trials, enrolling children in trials continues to be challenging. Non-investigator (those who have never served as a clinical trial investigator) providers are essential to recruitment of pediatric patients, but little is known regarding the specific barriers that limit pediatric providers from participating in and referring their patients to clinical trials. We conducted an online survey of pediatric providers from a wide variety of practice types across the United States to evaluate their attitudes and awareness of pediatric clinical trials. Using a 4-point Likert scale, providers described their perception of potential barriers to their practice serving as a site for pediatric clinical trials. Of the 136 providers surveyed, 52/136 (38%) had previously referred a pediatric patient to a trial, and only 17/136 (12%) had ever been an investigator for a pediatric trial. Lack of awareness of existing pediatric trials was a major barrier to patient referral by providers, in addition to consideration of trial risks, distance to the site, and time needed to discuss trial participation with parents. Overall, providers perceived greater challenges related to parental concerns and parent or child logistical barriers than study implementation and ethics or regulatory barriers as barriers to their practice serving as a trial site. Providers who had previously been an investigator for a pediatric trial were less likely to be concerned with potential barriers than non-investigators. Understanding the barriers that limit pediatric providers from collaboration or inhibit their participation is key to designing effective interventions to optimize pediatric trial participation.

  13. Comparison of reporting phase I trial results in ClinicalTrials.gov and matched publications.

    Science.gov (United States)

    Shepshelovich, D; Goldvaser, H; Wang, L; Abdul Razak, A R; Bedard, P L

    2017-12-01

    Background Data on completeness of reporting of phase I cancer clinical trials in publications are lacking. Methods The ClinicalTrials.gov database was searched for completed adult phase I cancer trials with reported results. PubMed was searched for matching primary publications published prior to November 1, 2016. Reporting in primary publications was compared with the ClinicalTrials.gov database using a 28-point score (2=complete; 1=partial; 0=no reporting) for 14 items related to study design, outcome measures and safety profile. Inconsistencies between primary publications and ClinicalTrials.gov were recorded. Linear regression was used to identify factors associated with incomplete reporting. Results After a review of 583 trials in ClinicalTrials.gov , 163 matching primary publications were identified. Publications reported outcomes that did not appear in ClinicalTrials.gov in 25% of trials. Outcomes were upgraded, downgraded or omitted in publications in 47% of trials. The overall median reporting score was 23/28 (interquartile range 21-25). Incompletely reported items in >25% publications were: inclusion criteria (29%), primary outcome definition (26%), secondary outcome definitions (53%), adverse events (71%), serious adverse events (80%) and dates of study start and database lock (91%). Higher reporting scores were associated with phase I (vs phase I/II) trials (ppublication in journals with lower impact factor (p=0.004). Conclusions Reported results in primary publications for early phase cancer trials are frequently inconsistent or incomplete compared with ClinicalTrials.gov entries. ClinicalTrials.gov may provide more comprehensive data from new cancer drug trials.

  14. Clinical Trials

    Medline Plus

    Full Text Available ... This shows how the approach affects a living body and whether it's 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 ...

  15. Tools in a clinical information system supporting clinical trials at a Swiss University Hospital.

    Science.gov (United States)

    Weisskopf, Michael; Bucklar, Guido; Blaser, Jürg

    2014-12-01

    Issues concerning inadequate source data of clinical trials rank second in the most common findings by regulatory authorities. The increasing use of electronic clinical information systems by healthcare providers offers an opportunity to facilitate and improve the conduct of clinical trials and the source documentation. We report on a number of tools implemented into the clinical information system of a university hospital to support clinical research. In 2011/2012, a set of tools was developed in the clinical information system of the University Hospital Zurich to support clinical research, including (1) a trial registry for documenting metadata on the clinical trials conducted at the hospital, (2) a patient-trial-assignment-tool to tag patients in the electronic medical charts as participants of specific trials, (3) medical record templates for the documentation of study visits and trial-related procedures, (4) online queries on trials and trial participants, (5) access to the electronic medical records for clinical monitors, (6) an alerting tool to notify of hospital admissions of trial participants, (7) queries to identify potentially eligible patients in the planning phase as trial feasibility checks and during the trial as recruitment support, and (8) order sets to facilitate the complete and accurate performance of study visit procedures. The number of approximately 100 new registrations per year in the voluntary trial registry in the clinical information system now matches the numbers of the existing mandatory trial registry of the hospital. Likewise, the yearly numbers of patients tagged as trial participants as well as the use of the standardized trial record templates increased to 2408 documented trial enrolments and 190 reports generated/month in the year 2013. Accounts for 32 clinical monitors have been established in the first 2 years monitoring a total of 49 trials in 16 clinical departments. A total of 15 months after adding the optional feature of

  16. ATCA Shelf Manager EPICS device support for ITER CODAC Core System

    Energy Technology Data Exchange (ETDEWEB)

    Santos, Bruno, E-mail: bsantos@ipfn.ist.utl.pt [Instituto de Plasmas e Fusão Nuclear, Instituto Superior Técnico, Universidade de Lisboa, 1049-001 Lisboa (Portugal); Carvalho, Paulo F.; Rodrigues, A.P.; Carvalho, Bernardo B.; Sousa, Jorge; Batista, António J.N.; Correia, Miguel; Combo, Álvaro M.; Cruz, Nuno [Instituto de Plasmas e Fusão Nuclear, Instituto Superior Técnico, Universidade de Lisboa, 1049-001 Lisboa (Portugal); Correia, Carlos M.B.A. [Centro de Instrumentação, Departamento de Física, Universidade de Coimbra, 3004-516 Coimbra (Portugal); Gonçalves, Bruno [Instituto de Plasmas e Fusão Nuclear, Instituto Superior Técnico, Universidade de Lisboa, 1049-001 Lisboa (Portugal)

    2015-10-15

    Highlights: • This architecture targets the health management integration into the NDS. • The developed solution supports the ShM redundancy features, specified by ATCA. • The average RTT was around 59 ms and in 99.9% of the cases was less than 130 ms. • Without losing any update cycle, can monitor a system shelf with approximately 400 sensors. • This solution enables the user to configure the entire system in DB files and st.cmd. - Abstract: The ITER CODAC Core System (CCS) is responsible for plant Instrumentation and Control (I&C) supervising and monitoring. This system uses the Enhanced Physics and Industrial Control System (EPICS) Channel Access (CA) protocol as the interface with the Plant Operation Network (PON). This paper presents a generic EPICS device support developed for the integration of the ATCA Shelf Manager (ShM) into the ITER CCS, providing scalability and easy configuration. The device support uses the available HTTP interface on Shelf Manager in the communication layer. Both HTTP server and sensors/actuators definitions can be configured using the EPICS database file and the Input/Output Controller (IOC) initialization file. A proposal based on this device is also presented, targeting the Nominal Device Support (NDS) for health management. The EPICS device support running in an IOC provides Process Variables (PV) to the PON network with the system information and these PVs can be used by all CA clients, such as EPICS user interface clients, alarm systems and archive systems. Operation with redundant ATCA ShMs and device support scalability tests were performed and the results are presented.

  17. DSCOVR/EPIC observations of SO2 reveal dynamics of young volcanic eruption clouds

    Science.gov (United States)

    Carn, S. A.; Krotkov, N. A.; Taylor, S.; Fisher, B. L.; Li, C.; Bhartia, P. K.; Prata, F. J.

    2017-12-01

    Volcanic emissions of sulfur dioxide (SO2) and ash have been measured by ultraviolet (UV) and infrared (IR) sensors on US and European polar-orbiting satellites since the late 1970s. Although successful, the main limitation of these observations from low Earth orbit (LEO) is poor temporal resolution (once per day at low latitudes). Furthermore, most currently operational geostationary satellites cannot detect SO2, a key tracer of volcanic plumes, limiting our ability to elucidate processes in fresh, rapidly evolving volcanic eruption clouds. In 2015, the launch of the Earth Polychromatic Imaging Camera (EPIC) aboard the Deep Space Climate Observatory (DSCOVR) provided the first opportunity to observe volcanic clouds from the L1 Lagrange point. EPIC is a 10-band spectroradiometer spanning UV to near-IR wavelengths with two UV channels sensitive to SO2, and a ground resolution of 25 km. The unique L1 vantage point provides continuous observations of the sunlit Earth disk, from sunrise to sunset, offering multiple daily observations of volcanic SO2 and ash clouds in the EPIC field of view. When coupled with complementary retrievals from polar-orbiting UV and IR sensors such as the Ozone Monitoring Instrument (OMI), the Ozone Mapping and Profiler Suite (OMPS), and the Atmospheric Infrared Sounder (AIRS), we demonstrate how the increased observation frequency afforded by DSCOVR/EPIC permits more timely volcanic eruption detection and novel analyses of the temporal evolution of volcanic clouds. Although EPIC has detected several mid- to high-latitude volcanic eruptions since launch, we focus on recent eruptions of Bogoslof volcano (Aleutian Islands, AK, USA). A series of EPIC exposures from May 28-29, 2017, uniquely captures the evolution of SO2 mass in a young Bogoslof eruption cloud, showing separation of SO2- and ice-rich regions of the cloud. We show how analyses of these sequences of EPIC SO2 data can elucidate poorly understood processes in transient eruption

  18. NCI National Clinical Trials Network Structure

    Science.gov (United States)

    Learn about how the National Clinical Trials Network (NCTN) is structured. The NCTN is a program of the National Cancer Institute that gives funds and other support to cancer research organizations to conduct cancer clinical trials.

  19. Problematic trial detection in ClinicalTrials.gov

    NARCIS (Netherlands)

    Hartgerink, C.H.J.; George, Stephen

    2015-01-01

    Clinical trials are crucial in determining the effectiveness of treatments and directly affect clinical and policy decisions. These decisions are undermined if the data are problematic due to data fabrication or other errors. Researchers have worked on developing statistical methods to detect

  20. A Woman Voice in an Epic: Tracing Gendered Motifs in Anne Vabarna's Peko

    Directory of Open Access Journals (Sweden)

    Andreas Kalkun

    2008-12-01

    Full Text Available In the article the gendered motifs found in Anne Vabarna’s Seto epic Peko are analysed. Besides the narrative telling of the life of the male hero, the motives regarding eating, refusing to eat or offering food, and the aspect of the female body or its control deserve to be noticed. These scenes do not communicate the main plot, they are often related to minor characters of the epic and slow down the narrative, but at the same time they clearly carry artistic purpose and meaning. I consider these motifs, present in the liminal parts of the epic, to be the dominant symbols of the epic where the author’s feminine world is being exposed. Observing these motifs of Peko in the context of Seto religious worldview, the life of Anne Vabarna and the social position of Seto women, the symbols become eloquent and informative.

  1. Standards for Clinical Trials in Male and Female Sexual Dysfunction: I. Phase I to Phase IV Clinical Trial Design.

    Science.gov (United States)

    Fisher, William A; Gruenwald, Ilan; Jannini, Emmanuele A; Lev-Sagie, Ahinoam; Lowenstein, Lior; Pyke, Robert E; Reisman, Yakov; Revicki, Dennis A; Rubio-Aurioles, Eusebio

    2016-12-01

    This series of articles outlines standards for clinical trials of treatments for male and female sexual dysfunctions, with a focus on research design and patient-reported outcome assessment. These articles consist of revision, updating, and integration of articles on standards for clinical trials in male and female sexual dysfunction from the 2010 International Consultation on Sexual Medicine developed by the authors as part of the 2015 International Consultation on Sexual Medicine. We are guided in this effort by several principles. In contrast to previous versions of these guidelines, we merge discussion of standards for clinical trials in male and female sexual dysfunction in an integrated approach that emphasizes the common foundational practices that underlie clinical trials in the two settings. We present a common expected standard for clinical trial design in male and female sexual dysfunction, a common rationale for the design of phase I to IV clinical trials, and common considerations for selection of study population and study duration in male and female sexual dysfunction. We present a focused discussion of fundamental principles in patient- (and partner-) reported outcome assessment and complete this series of articles with specific discussions of selected aspects of clinical trials that are unique to male and to female sexual dysfunction. Our consideration of standards for clinical trials in male and female sexual dysfunction attempts to embody sensitivity to existing and new regulatory guidance and to address implications of the evolution of the diagnosis of sexual dysfunction that have been brought forward in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition. The first article in this series focuses on phase I to phase IV clinical trial design considerations. Subsequent articles in this series focus on the measurement of patient-reported outcomes, unique aspects of clinical trial design for men, and unique aspects of clinical

  2. Clinical trials attitudes and practices of Latino physicians.

    Science.gov (United States)

    Ramirez, Amelie G; Wildes, Kimberly; Talavera, Greg; Nápoles-Springer, Anna; Gallion, Kipling; Pérez-Stable, Eliseo J

    2008-07-01

    Ethnic differences in physicians' attitudes and behaviors related to clinical trials might partially account for disparities in clinical trial participation among Latino patients. Literature regarding Latino physicians' clinical trials attitudes and practices, in comparison to White physicians, was lacking. Cross-sectional data from randomly selected physicians (N=695), stratified by ethnicity, were analyzed to test associations of ethnicity with physicians' participation in and attitudes toward referral of patients to clinical trials. Chi-square analyses showed significant (pLatino physicians were significantly less involved in clinical trials than White physicians and found less scientific value in them, highlighting areas for future education and intervention.

  3. Sustainable development of a GCP-compliant clinical trials platform in Africa: the malaria clinical trials alliance perspective.

    Science.gov (United States)

    Ogutu, Bernhards R; Baiden, Rita; Diallo, Diadier; Smith, Peter G; Binka, Fred N

    2010-04-20

    The Malaria Clinical Trials Alliance (MCTA), a programme of INDEPTH network of demographic surveillance centres, was launched in 2006 with two broad objectives: to facilitate the timely development of a network of centres in Africa with the capacity to conduct clinical trials of malaria vaccines and drugs under conditions of good clinical practice (GCP); and to support, strengthen and mentor the centres in the network to facilitate their progression towards self-sustaining clinical research centres. Sixteen research centres in 10 African malaria-endemic countries were selected that were already working with the Malaria Vaccine Initiative (MVI) or the Medicines for Malaria Venture (MMV). All centres were visited to assess their requirements for research capacity development through infrastructure strengthening and training. Support provided by MCTA included: laboratory and facility refurbishment; workshops on GCP, malaria diagnosis, strategic management and media training; and training to support staff to undertake accreditation examinations of the Association of Clinical Research Professionals (ACRP). Short attachments to other network centres were also supported to facilitate sharing practices within the Alliance. MCTA also played a key role in the creation of the African Media & Malaria Research Network (AMMREN), which aims to promote interaction between researchers and the media for appropriate publicity and media reporting of research and developments on malaria, including drug and vaccine trials. In three years, MCTA strengthened 13 centres to perform GCP-compliant drug and vaccine trials, including 11 centres that form the backbone of a large phase III malaria vaccine trial. MCTA activities have demonstrated that centres can be brought up to GCP compliance on this time scale, but the costs are substantial and there is a need for further support of other centres to meet the growing demand for clinical trial capacity. The MCTA experience also indicates that

  4. Quality assurance of the international computerised 24 h dietary recall method (EPIC-Soft).

    Science.gov (United States)

    Crispim, Sandra P; Nicolas, Genevieve; Casagrande, Corinne; Knaze, Viktoria; Illner, Anne-Kathrin; Huybrechts, Inge; Slimani, Nadia

    2014-02-01

    The interview-administered 24 h dietary recall (24-HDR) EPIC-Soft® has a series of controls to guarantee the quality of dietary data across countries. These comprise all steps that are part of fieldwork preparation, data collection and data management; however, a complete characterisation of these quality controls is still lacking. The present paper describes in detail the quality controls applied in EPIC-Soft, which are, to a large extent, built on the basis of the EPIC-Soft error model and are present in three phases: (1) before, (2) during and (3) after the 24-HDR interviews. Quality controls for consistency and harmonisation are implemented before the interviews while preparing the seventy databases constituting an EPIC-Soft version (e.g. pre-defined and coded foods and recipes). During the interviews, EPIC-Soft uses a cognitive approach by helping the respondent to recall the dietary intake information in a stepwise manner and includes controls for consistency (e.g. probing questions) as well as for completeness of the collected data (e.g. system calculation for some unknown amounts). After the interviews, a series of controls can be applied by dietitians and data managers to further guarantee data quality. For example, the interview-specific 'note files' that were created to track any problems or missing information during the interviews can be checked to clarify the information initially provided. Overall, the quality controls employed in the EPIC-Soft methodology are not always perceivable, but prove to be of assistance for its overall standardisation and possibly for the accuracy of the collected data.

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

    Science.gov (United States)

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

    2016-05-01

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

  6. Configuration and application of He RFQ LLRF control system based on EPICS

    Energy Technology Data Exchange (ETDEWEB)

    Ahn, Tae-Sung; Jeong, Hae-Seong; Kim, Seong-Gu; Song, Young-Gi; Kim, Han-Sung; Seol, Kyung-Tae; Kwon, Hyeok-Jung; Cho, Yong-Sub [Korea Multipurpose Accelerator Complex, Gyeongju (Korea, Republic of)

    2015-10-15

    In He RFQ device, the high-power Radio-Frequency (RF) is very important because it is responsible for the stable delivery and efficient acceleration of the beam. Since that, the control system of high-power Radio-Frequency must be developed and this system is called LLRF control system. The LLRF control system required exquisite amplitude value that has ±1 % error range. We need a precise remote control system for this reason. This paper represents the configuration of LLRF control system in terms of software layers based on EPICS. Also, this paper explains the application of LLRF control system to test environment (hardware) and represents test result and suggests future work. The LLRF control system at the He RFQ is very important. The configuration of LLRF control system is completed on the software side and hardware modules: vxworks operating system installation, EPICS BASE compilation, module source code compiled, object file loading and execution on vxworks, EPICS IOC operation check, etc. The application of LLRF control system to module is implemented well: ADC module, DAC module, EPICS IOC test.

  7. A study of some features of the ultra high vacuum systems for EPIC

    International Nuclear Information System (INIS)

    Elsey, R.J.; Bennett, J.R.J.; Dossett, A.J.

    1977-01-01

    This report covers the experimental work carried out towards the development of the ultra high vacuum for the proposed electron positron storage ring, EPIC. Experiments included outgassing tests on samples of materials and pump-down tests on full scale aluminium vessels. The effect of baking was investigated. The approval of the similar machine PETRA at Hamburg and the subsequent withdrawal of the EPIC proposal in October 1975 curtailed the vacuum work. The experiments reported here are therefore incomplete, but nevertheless proved useful in showing that there should have been no major problems with building the vacuum system for EPIC. (author)

  8. EPICS Input/Output Controller (IOC) application developer's guide. APS Release 3.12

    International Nuclear Information System (INIS)

    Kraimer, M.R.

    1994-11-01

    This document describes the core software that resides in an Input/Output Controller (IOC), one of the major components of EPICS. The basic components are: (OPI) Operator Interface; this is a UNIX based workstation which can run various EPICS tools; (IOC) Input/Output Controller; this is a VME/VXI based chassis containing a Motorola 68xxx processor, various I/O modules, and VME modules that provide access to other I/O buses such as GPIB, (LAN), Local Area Network; and this is the communication network which allows the IOCs and OPIs to communicate. Epics provides a software component, Channel Access, which provides network transparent communication between a Channel Access client and an arbitrary number of Channel Access servers

  9. Clinical Trials

    Medline Plus

    Full Text Available ... treatments produce better results for certain illnesses or groups of people; look at the best age and frequency for doing screening tests, such as mammography; and compare two or more screening tests to see which test ... Some companies and groups sponsor clinical trials that test the safety of ...

  10. Clinical Trials

    Medline Plus

    Full Text Available ... benefits of lowering high blood pressure in the elderly outweighed the risks. Other examples of clinical trials ... child to enroll. Also, children aged 7 and older often must agree (assent) to take part ... about how you feel. Some people will need to travel or stay in hospitals ...

  11. Clinical Trials

    Medline Plus

    Full Text Available ... As a result, the U.S. Food and Drug Administration now recommends never using HT to prevent heart disease. When HT is used for menopausal symptoms, it should be taken only at the smallest dose and for the shortest time possible. Clinical trials, like the two described above, ...

  12. Maximizing scientific knowledge from randomized clinical trials

    DEFF Research Database (Denmark)

    Gustafsson, Finn; Atar, Dan; Pitt, Bertram

    2010-01-01

    Trialists have an ethical and financial responsibility to plan and conduct clinical trials in a manner that will maximize the scientific knowledge gained from the trial. However, the amount of scientific information generated by randomized clinical trials in cardiovascular medicine is highly vari...

  13. Adaptive designs in clinical trials

    Directory of Open Access Journals (Sweden)

    Suresh Bowalekar

    2011-01-01

    Full Text Available In addition to the expensive and lengthy process of developing a new medicine, the attrition rate in clinical research was on the rise, resulting in stagnation in the development of new compounds. As a consequence to this, the US Food and Drug Administration released a critical path initiative document in 2004, highlighting the need for developing innovative trial designs. One of the innovations suggested the use of adaptive designs for clinical trials. Thus, post critical path initiative, there is a growing interest in using adaptive designs for the development of pharmaceutical products. Adaptive designs are expected to have great potential to reduce the number of patients and duration of trial and to have relatively less exposure to new drug. Adaptive designs are not new in the sense that the task of interim analysis (IA/review of the accumulated data used in adaptive designs existed in the past too. However, such reviews/analyses of accumulated data were not necessarily planned at the stage of planning clinical trial and the methods used were not necessarily compliant with clinical trial process. The Bayesian approach commonly used in adaptive designs was developed by Thomas Bayes in the 18th century, about hundred years prior to the development of modern statistical methods by the father of modern statistics, Sir Ronald A. Fisher, but the complexity involved in Bayesian approach prevented its use in real life practice. The advances in the field of computer and information technology over the last three to four decades has changed the scenario and the Bayesian techniques are being used in adaptive designs in addition to other sequential methods used in IA. This paper attempts to describe the various adaptive designs in clinical trial and views of stakeholders about feasibility of using them, without going into mathematical complexities.

  14. Adaptive designs in clinical trials.

    Science.gov (United States)

    Bowalekar, Suresh

    2011-01-01

    In addition to the expensive and lengthy process of developing a new medicine, the attrition rate in clinical research was on the rise, resulting in stagnation in the development of new compounds. As a consequence to this, the US Food and Drug Administration released a critical path initiative document in 2004, highlighting the need for developing innovative trial designs. One of the innovations suggested the use of adaptive designs for clinical trials. Thus, post critical path initiative, there is a growing interest in using adaptive designs for the development of pharmaceutical products. Adaptive designs are expected to have great potential to reduce the number of patients and duration of trial and to have relatively less exposure to new drug. Adaptive designs are not new in the sense that the task of interim analysis (IA)/review of the accumulated data used in adaptive designs existed in the past too. However, such reviews/analyses of accumulated data were not necessarily planned at the stage of planning clinical trial and the methods used were not necessarily compliant with clinical trial process. The Bayesian approach commonly used in adaptive designs was developed by Thomas Bayes in the 18th century, about hundred years prior to the development of modern statistical methods by the father of modern statistics, Sir Ronald A. Fisher, but the complexity involved in Bayesian approach prevented its use in real life practice. The advances in the field of computer and information technology over the last three to four decades has changed the scenario and the Bayesian techniques are being used in adaptive designs in addition to other sequential methods used in IA. This paper attempts to describe the various adaptive designs in clinical trial and views of stakeholders about feasibility of using them, without going into mathematical complexities.

  15. The coal epic at Freyming-Merlebach

    International Nuclear Information System (INIS)

    2003-01-01

    This information document has been realized on the closure of the Merlebach site. It is devoted to the coal epic at Freyming-Merlebach. The historical aspects of the exploitation, the working conditions, the economic and environmental aspects of the mine and the today situation are detailed. (A.L.B.)

  16. Preliminary design and integration of EPICS operation interface for the Taiwan photon source

    International Nuclear Information System (INIS)

    Cheng, Y.S.; Jenny Chen; Chiu, P.C.; Kuo, C.H.; Liao, C.Y.; Hsu, K.T.; Wu, C.Y.

    2012-01-01

    The TPS (Taiwan Photon Source) is the latest generation 3 GeV synchrotron light source which has been in construction since 2010. The EPICS (Experimental Physics and Industrial Control System) framework is adopted as control system infrastructure for the TPS. The EPICS IOCs (Input Output Controller) and various database records have been gradually implemented to control and monitor available subsystems of the TPS at this moment. The subsystem includes timing, power supply, motion controller, miscellaneous Ethernet compliant devices etc. Through EPICS PVs (Process Variables) channel access, remote access I/O data via Ethernet interface can be observed by the usable graphical tool-kits, such as the EDM (Extensible Display Manager) and MATLAB. The operation interface mainly includes the function of setting, reading, save, restore and etc. Integration of operation interfaces will depend upon properties of each subsystem. In addition, the centralized management method is utilized to serve every client from file servers in order to maintain consistent versions of related EPICS files. (authors)

  17. Impact of a cancer clinical trials web site on discussions about trial participation: a cluster randomized trial.

    Science.gov (United States)

    Dear, R F; Barratt, A L; Askie, L M; Butow, P N; McGeechan, K; Crossing, S; Currow, D C; Tattersall, M H N

    2012-07-01

    Cancer patients want access to reliable information about currently recruiting clinical trials. Oncologists and their patients were randomly assigned to access a consumer-friendly cancer clinical trials web site [Australian Cancer Trials (ACT), www.australiancancertrials.gov.au] or to usual care in a cluster randomized controlled trial. The primary outcome, measured from audio recordings of oncologist-patient consultations, was the proportion of patients with whom participation in any clinical trial was discussed. Analysis was by intention-to-treat accounting for clustering and stratification. Thirty medical oncologists and 493 patients were recruited. Overall, 46% of consultations in the intervention group compared with 34% in the control group contained a discussion about clinical trials (P=0.08). The mean consultation length in both groups was 29 min (P=0.69). The proportion consenting to a trial was 10% in both groups (P=0.65). Patients' knowledge about randomized trials was lower in the intervention than the control group (mean score 3.0 versus 3.3, P=0.03) but decisional conflict scores were similar (mean score 42 versus 43, P=0.83). Good communication between patients and physicians is essential. Within this context, a web site such as Australian Cancer Trials may be an important tool to encourage discussion about clinical trial participation.

  18. RIO EPICS device support application case study on an ion source control system (ISHP)

    Energy Technology Data Exchange (ETDEWEB)

    Sanz, Diego [UPM – Universidad Politécnica de Madrid, Madrid (Spain); Ruiz, Mariano, E-mail: mariano.ruiz@upm.es [UPM – Universidad Politécnica de Madrid, Madrid (Spain); Eguiraun, Mikel [Department of Electricity and Electronic, Faculty of Science and Technology, University of Basque Country, Bilbao (Spain); Arredondo, Iñigo [ESS Bilbao Consortium, Zamudio (Spain); Badillo, Inari; Jugo, Josu [Department of Electricity and Electronic, Faculty of Science and Technology, University of Basque Country, Bilbao (Spain); Vega, Jesús; Castro, Rodrigo [Asociación EURATOM/CIEMAT, Madrid (Spain)

    2015-10-15

    Highlights: • A use case example of RIO/FlexRIO design methodology is described. • Ion source device is controlled and monitored by means EPICS IOCs. • NIRIO EPICS device support demonstrates that is able to manage RIO devices. • Easy and fast deployment is possible using RIO/FlexRIO design methodology using NIRIO-EDS. • RIO/FlexRIO technology and EPICS are a good combination for support large scale experiments in fusion environments. - Abstract: Experimental Physics and Industrial Control System (EPICS) is a software tool that during last years has become relevant as a main framework to deploy distributed control systems in large scientific environments. At the moment, ESS Bilbao uses this middleware to perform the control of their Ion Source Hydrogen Positive (ISHP) project. The implementation of the control system was based on: PXI Real Time controllers using the LabVIEW-RT and LabVIEW-EPICS tools; and RIO devices based on Field-Programmable Gate Array (FPGA) technology. Intended to provide a full compliant EPICS IOCs for RIO devices and to avoid additional efforts on the system maintainability, a migration of the current system to a derivative Red Hat Linux (CentOS) environment has been conducted. This paper presents a real application case study for using the NIRIO EPICS device support (NIRIO-EDS) to give support to the ISHP. Although RIO FPGA configurations are particular solutions for ISHP performance, the NIRIO-EDS has permitted the control and monitoring of devices by applying a well-defined design methodology into the previous FPGA configuration for RIO/FlexRIO devices. This methodology has permitted a fast and easy deployment for the new robust, scalable and maintainable software to support RIO devices into the ISHP control architecture.

  19. ClinicalTrials.gov

    Data.gov (United States)

    U.S. Department of Health & Human Services — Provides patients, family members, health care professionals, and members of the public easy access to information on clinical trials for a wide range of diseases...

  20. OARSI Clinical Trials Recommendations: Design and conduct of clinical trials of lifestyle diet and exercise interventions for osteoarthritis.

    Science.gov (United States)

    Messier, S P; Callahan, L F; Golightly, Y M; Keefe, F J

    2015-05-01

    The objective was to develop a set of "best practices" for use as a primer for those interested in entering the clinical trials field for lifestyle diet and/or exercise interventions in osteoarthritis (OA), and as a set of recommendations for experienced clinical trials investigators. A subcommittee of the non-pharmacologic therapies committee of the OARSI Clinical Trials Working Group was selected by the Steering Committee to develop a set of recommended principles for non-pharmacologic diet/exercise OA randomized clinical trials. Topics were identified for inclusion by co-authors and reviewed by the subcommittee. Resources included authors' expert opinions, traditional search methods including MEDLINE (via PubMed), and previously published guidelines. Suggested steps and considerations for study methods (e.g., recruitment and enrollment of participants, study design, intervention and assessment methods) were recommended. The recommendations set forth in this paper provide a guide from which a research group can design a lifestyle diet/exercise randomized clinical trial in patients with OA. Copyright © 2015 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved.

  1. Clinical Trials in Noninfectious Uveitis

    Science.gov (United States)

    Kim, Jane S.; Knickelbein, Jared E.; Nussenblatt, Robert B.; Sen, H. Nida

    2015-01-01

    The treatment of noninfectious uveitis continues to remain a challenge for many ophthalmologists. Historically, clinical trials in uveitis have been sparse, and thus, most treatment decisions have largely been based on clinical experience and consensus guidelines. The current treatment paradigm favors initiation then tapering of corticosteroids with addition of steroid-sparing immunosuppressive agents for persistence or recurrence of disease. Unfortunately, in spite of a multitude of highly unfavorable systemic effects, corticosteroids are still regarded as the mainstay of treatment for many patients with chronic and refractory noninfectious uveitis. However, with the success of other conventional and biologic immunomodulatory agents in treating systemic inflammatory and autoimmune conditions, interest in targeted treatment strategies for uveitis has been renewed. Multiple clinical trials on steroid-sparing immunosuppressive agents, biologic agents, intraocular corticosteroid implants, and topical ophthalmic solutions have already been completed, and many more are ongoing. This review discusses the results and implications of these clinical trials investigating both alternative and novel treatment options for noninfectious uveitis. PMID:26035763

  2. Parents' perceived obstacles to pediatric clinical trial participation: Findings from the clinical trials transformation initiative

    Directory of Open Access Journals (Sweden)

    Rachel G. Greenberg

    2018-03-01

    In order for clinical trial accrual to be successful, parents' priorities and considerations must be a central focus, beginning with initial trial design. The recommendations from the parents who participated in this study can be used to support budget allocations that ensure adequate training of study staff and improved staffing on nights and weekends. Studies of parent responses in outpatient settings and additional inpatient settings will provide valuable information on the consent process from the child's and parent's perspectives. Further studies are needed to explore whether implementation of such strategies will result in improved recruitment for pediatric clinical trials.

  3. Use of crowdsourcing for cancer clinical trial development.

    Science.gov (United States)

    Leiter, Amanda; Sablinski, Tomasz; Diefenbach, Michael; Foster, Marc; Greenberg, Alex; Holland, John; Oh, William K; Galsky, Matthew D

    2014-10-01

    Patient and physician awareness and acceptance of trials and patient ineligibility are major cancer clinical trial accrual barriers. Yet, trials are typically conceived and designed by small teams of researchers with limited patient input. We hypothesized that through crowdsourcing, the intellectual and creative capacity of a large number of researchers, clinicians, and patients could be harnessed to improve the clinical trial design process. In this study, we evaluated the feasibility and utility of using an internet-based crowdsourcing platform to inform the design of a clinical trial exploring an antidiabetic drug, metformin, in prostate cancer. Over a six-week period, crowd-sourced input was collected from 60 physicians/researchers and 42 patients/advocates leading to several major (eg, eligibility) and minor modifications to the clinical trial protocol as originally designed. Crowdsourcing clinical trial design is feasible, adds value to the protocol development process, and may ultimately improve the efficiency of trial conduct. © The Author 2014. Published by Oxford University Press. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

  4. The therapeutic effect of clinical trials: understanding placebo response rates in clinical trials – A secondary analysis

    Directory of Open Access Journals (Sweden)

    Walach Harald

    2005-08-01

    Full Text Available Abstract Background and purpose Placebo response rates in clinical trials vary considerably and are observed frequently. For new drugs it can be difficult to prove effectiveness superior to placebo. It is unclear what contributes to improvement in the placebo groups. We wanted to clarify, what elements of clinical trials determine placebo variability. Methods We analysed a representative sample of 141 published long-term trials (randomized, double-blind, placebo-controlled; duration > 12 weeks to find out what study characteristics predict placebo response rates in various diseases. Correlational and regression analyses with study characteristics and placebo response rates were carried out. Results We found a high and significant correlation between placebo and treatment response rate across diseases (r = .78; p Conclusion Medication response rates and placebo response rates in clinical trials are highly correlated. Trial characteristics can explain some portion of the variance in placebo healing rates in RCTs. Placebo response in trials is only partially due to methodological artefacts and only partially dependent on the diagnoses treated.

  5. Replica sizing strategy for aortic valve replacement improves haemodynamic outcome of the epic supra valve.

    Science.gov (United States)

    Gonzalez-Lopez, David; Faerber, Gloria; Diab, Mahmoud; Amorim, Paulo; Zeynalov, Natig; Doenst, Torsten

    2017-10-01

    Current sizing strategies suggest valve selection based on annulus diameter despite supra-annular placement of biological prostheses potentially allowing placement of a larger size. We assessed the frequency of selecting a larger prosthesis if prosthesis size was selected using a replica (upsizing) and evaluated its impact on haemodynamics. We analysed all discharge echocardiograms between June 2012 and June 2014, where a replica sizer was used for isolated aortic valve replacement (Epic Supra: 266 patients, Trifecta: 49 patients). Upsizing was possible in 71% of the Epic Supra valves (by 1 size: 168, by 2 sizes: 20) and in 59% of the Trifectas (by 1 size: 26, by 2 sizes: 3). Patients for whom upsizing was possible had the lowest pressure gradients within their annulus size groups. The difference was significant in annulus diameters of 21-22 or 25-26 mm (Epic Supra) and 23-24 mm (Trifecta). Trifecta gradients were the lowest. However, the ability to upsize the Epic Supra by 2 sizes eliminated the differences between Epic Supra and Trifecta. Upsizing did not cause intraoperative complications. Using replica sizers for aortic prosthesis size selection allows the implantation of bigger prostheses than recommended in most cases and reduces postoperative gradients, specifically for Epic Supra. © The Author 2017. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

  6. Cancer clinical trials

    International Nuclear Information System (INIS)

    Scheurlen, A.; Kay, R.; Baum, M.

    1988-01-01

    This book contains the proceedings on Cancer clinical trials: A critical appraisal. Topics covered include: Scientific fundamentals; Heterogeneous treatment effects; On combining information: Historical controls, overviews, and comprehensive cohort studies; and assessment of quality of life

  7. Clinical trials in neurology: design, conduct, analysis

    National Research Council Canada - National Science Library

    Ravina, Bernard

    2012-01-01

    .... Clinical Trials in Neurology aims to improve the efficiency of clinical trials and the development of interventions in order to enhance the development of new treatments for neurologic diseases...

  8. The clinically-integrated randomized trial: proposed novel method for conducting large trials at low cost

    Directory of Open Access Journals (Sweden)

    Scardino Peter T

    2009-03-01

    Full Text Available Abstract Introduction Randomized controlled trials provide the best method of determining which of two comparable treatments is preferable. Unfortunately, contemporary randomized trials have become increasingly expensive, complex and burdened by regulation, so much so that many trials are of doubtful feasibility. Discussion Here we present a proposal for a novel, streamlined approach to randomized trials: the "clinically-integrated randomized trial". The key aspect of our methodology is that the clinical experience of the patient and doctor is virtually indistinguishable whether or not the patient is randomized, primarily because outcome data are obtained from routine clinical data, or from short, web-based questionnaires. Integration of a randomized trial into routine clinical practice also implies that there should be an attempt to randomize every patient, a corollary of which is that eligibility criteria are minimized. The similar clinical experience of patients on- and off-study also entails that the marginal cost of putting an additional patient on trial is negligible. We propose examples of how the clinically-integrated randomized trial might be applied in four distinct areas of medicine: comparisons of surgical techniques, "me too" drugs, rare diseases and lifestyle interventions. Barriers to implementing clinically-integrated randomized trials are discussed. Conclusion The proposed clinically-integrated randomized trial may allow us to enlarge dramatically the number of clinical questions that can be addressed by randomization.

  9. Reinventing clinical trials: a review of innovative biomarker trial designs in cancer therapies.

    Science.gov (United States)

    Lin, Ja-An; He, Pei

    2015-06-01

    Recently, new clinical trial designs involving biomarkers have been studied and proposed in cancer clinical research, in the hope of incorporating the rapid growing basic research into clinical practices. Journal articles related to various biomarkers and their role in cancer clinical trial, articles and books about statistical issues in trial design, and regulatory website, documents, and guidance for submission of targeted cancer therapies. The drug development process involves four phases. The confirmatory Phase III is essential in regulatory approval of a special treatment. Regulatory agency has restrictions on confirmatory trials 'using adaptive designs'. No rule of thumb to pick the most appropriate design for biomarker-related trials. Statistical issues to solve in new designs. Regulatory acceptance of the 'newly proposed trial designs'. Biomarker-related trial designs that can resolve the statistical issues and satisfy the regulatory requirement. © The Author 2015. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  10. Microbicide clinical trial adherence: insights for introduction.

    Science.gov (United States)

    Woodsong, Cynthia; MacQueen, Kathleen; Amico, K Rivet; Friedland, Barbara; Gafos, Mitzy; Mansoor, Leila; Tolley, Elizabether; McCormack, Sheena

    2013-04-08

    After two decades of microbicide clinical trials it remains uncertain if vaginally- delivered products will be clearly shown to reduce the risk of HIV infection in women and girls. Furthermore, a microbicide product with demonstrated clinical efficacy must be used correctly and consistently if it is to prevent infection. Information on adherence that can be gleaned from microbicide trials is relevant for future microbicide safety and efficacy trials, pre-licensure implementation trials, Phase IV post-marketing research, and microbicide introduction and delivery. Drawing primarily from data and experience that has emerged from the large-scale microbicide efficacy trials completed to-date, the paper identifies six broad areas of adherence lessons learned: (1) Adherence measurement in clinical trials, (2) Comprehension of use instructions/Instructions for use, (3) Unknown efficacy and its effect on adherence/Messages regarding effectiveness, (4) Partner influence on use, (5) Retention and continuation and (6) Generalizability of trial participants' adherence behavior. Each is discussed, with examples provided from microbicide trials. For each of these adherence topics, recommendations are provided for using trial findings to prepare for future microbicide safety and efficacy trials, Phase IV post-marketing research, and microbicide introduction and delivery programs.

  11. Interpreting clinical trial results by deductive reasoning: In search of improved trial design.

    Science.gov (United States)

    Kurbel, Sven; Mihaljević, Slobodan

    2017-10-01

    Clinical trial results are often interpreted by inductive reasoning, in a trial design-limited manner, directed toward modifications of the current clinical practice. Deductive reasoning is an alternative in which results of relevant trials are combined in indisputable premises that lead to a conclusion easily testable in future trials. © 2017 WILEY Periodicals, Inc.

  12. OARSI Clinical Trials Recommendations: Hand imaging in clinical trials in osteoarthritis.

    Science.gov (United States)

    Hunter, D J; Arden, N; Cicuttini, F; Crema, M D; Dardzinski, B; Duryea, J; Guermazi, A; Haugen, I K; Kloppenburg, M; Maheu, E; Miller, C G; Martel-Pelletier, J; Ochoa-Albíztegui, R E; Pelletier, J-P; Peterfy, C; Roemer, F; Gold, G E

    2015-05-01

    Tremendous advances have occurred in our understanding of the pathogenesis of hand osteoarthritis (OA) and these are beginning to be applied to trials targeted at modification of the disease course. The purpose of this expert opinion, consensus driven exercise is to provide detail on how one might use and apply hand imaging assessments in disease modifying clinical trials. It includes information on acquisition methods/techniques (including guidance on positioning for radiography, sequence/protocol recommendations/hardware for MRI); commonly encountered problems (including positioning, hardware and coil failures, sequences artifacts); quality assurance/control procedures; measurement methods; measurement performance (reliability, responsiveness, validity); recommendations for trials; and research recommendations. Copyright © 2015 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved.

  13. Do clinical trials conducted in India match its healthcare needs? An audit of the Clinical Trials Registry of India

    Directory of Open Access Journals (Sweden)

    Mansi Chaturvedi

    2017-01-01

    Full Text Available Background: India continues to contribute disproportionately to the global burden of disease and public health research output from India is also known to be not commensurate with her healthcare needs. We carried out the present study to assess if clinical trials were in line with the health care needs of the country by auditing the clinical trials registry of India. Materials and Methods: All the clinical studies registered in CTRI between July 20, 2007 and December 31, 2015 were searched in the “Trial Search” section. The total number of studies, their phases of development, and therapeutic areas were assessed. Trials in each therapeutic area was compared with the disease burden (DALYs in that area taken from Global Health Estimates [2014] Summary Tables of the WHO. The number of trials conducted per state in India was also compared with the population of that state [Census 2011]. Results: A total of 6474 studies were registered of which 3325 (51.4% were clinical trials. The state of Maharashtra had the highest number trials [16.4%] followed by Karnataka ( 11.6% and Tamil Nadu (10%. Populous states like Uttar Pradesh (5.3% and Bihar (1.4% had far fewer trials. The largest number of trials was in the area of cancer (16.4%, followed by diabetes (12.1% and cardiovascular diseases (10.1%. Infectious and parasitic diseases had the highest DALYs (82,681 and ranked first in disease burden but accounted for only 5% of the total trials and ranked 7th according to number of trials. Cancer ranked first in the number of trials (16.4%, but ranked 6th based on DALYs. Conclusion: Clinical trials conducted in India are not in consonance with her health care needs. Strengthening the capacity for conducting trials in the populous states and the north-eastern part of the country is necessary to allow a more equitable selection of participants. The government should introduce policies to encourage new drug development in areas where needed the most.

  14. 75 FR 65985 - Safety Zone: Epic Roasthouse Private Party Firework Display, San Francisco, CA

    Science.gov (United States)

    2010-10-27

    ... the navigable waters of San Francisco Bay 1,000 yards off Epic Roasthouse Restaurant, San Francisco.... Wright, Program Manager, Docket Operations, telephone 202-366-9826. SUPPLEMENTARY INFORMATION: Regulatory... waters of San Francisco Bay, 1,000 yards off Epic Roasthouse Restaurant, San Francisco, CA. The fireworks...

  15. Utilization of a Clinical Trial Management System for the Whole Clinical Trial Process as an Integrated Database: System Development.

    Science.gov (United States)

    Park, Yu Rang; Yoon, Young Jo; Koo, HaYeong; Yoo, Soyoung; Choi, Chang-Min; Beck, Sung-Ho; Kim, Tae Won

    2018-04-24

    Clinical trials pose potential risks in both communications and management due to the various stakeholders involved when performing clinical trials. The academic medical center has a responsibility and obligation to conduct and manage clinical trials while maintaining a sufficiently high level of quality, therefore it is necessary to build an information technology system to support standardized clinical trial processes and comply with relevant regulations. The objective of the study was to address the challenges identified while performing clinical trials at an academic medical center, Asan Medical Center (AMC) in Korea, by developing and utilizing a clinical trial management system (CTMS) that complies with standardized processes from multiple departments or units, controlled vocabularies, security, and privacy regulations. This study describes the methods, considerations, and recommendations for the development and utilization of the CTMS as a consolidated research database in an academic medical center. A task force was formed to define and standardize the clinical trial performance process at the site level. On the basis of the agreed standardized process, the CTMS was designed and developed as an all-in-one system complying with privacy and security regulations. In this study, the processes and standard mapped vocabularies of a clinical trial were established at the academic medical center. On the basis of these processes and vocabularies, a CTMS was built which interfaces with the existing trial systems such as the electronic institutional review board health information system, enterprise resource planning, and the barcode system. To protect patient data, the CTMS implements data governance and access rules, and excludes 21 personal health identifiers according to the Health Insurance Portability and Accountability Act (HIPAA) privacy rule and Korean privacy laws. Since December 2014, the CTMS has been successfully implemented and used by 881 internal and

  16. Education for Change: Epic Charter School

    Science.gov (United States)

    EDUCAUSE, 2015

    2015-01-01

    The student-centered school model of Epic Charter School in Oakland, California, framed around a hero's journey empowers middle school students with sense of unity and purpose in life, where they can feel part of a culture with a shared experience and with more opportunities to experiences growth and accomplishment. Design and engineering is front…

  17. Implementation of EPICS based vacuum control system for variable energy cyclotron centre, Kolkata

    Science.gov (United States)

    Roy, Anindya; Bhole, R. B.; Nandy, Partha P.; Yadav, R. C.; Pal, Sarbajit; Roy, Amitava

    2015-03-01

    The vacuum system of the Room Temperature (K = 130) Cyclotron of Variable Energy Cyclotron Centre is comprised of vacuum systems of main machine and Beam Transport System. The vacuum control system is upgraded to a PLC based Automated system from the initial relay based Manual system. The supervisory control of the vacuum system is implemented in Experimental Physics and Industrial Control System (EPICS). An EPICS embedded ARM based vacuum gauge controller is developed to mitigate the requirement of vendor specific gauge controller for gauges and also for seamless integration of the gauge controllers with the control system. A set of MS-Windows ActiveX components with embedded EPICS Channel Access interface are developed to build operator interfaces with less complex programming and to incorporate typical Windows feature, e.g., user authentication, file handling, better fonts, colors, mouse actions etc. into the operator interfaces. The control parameters, monitoring parameters, and system interlocks of the system are archived in MySQL based EPICS MySQL Archiver developed indigenously. In this paper, we describe the architecture, the implementation details, and the performance of the system.

  18. Implementation of EPICS based vacuum control system for variable energy cyclotron centre, Kolkata

    Energy Technology Data Exchange (ETDEWEB)

    Roy, Anindya, E-mail: r-ani@vecc.gov.in; Bhole, R. B.; Nandy, Partha P.; Yadav, R. C.; Pal, Sarbajit; Roy, Amitava [Variable Energy Cyclotron Centre, 1/AF Bidhan Nagar, Kolkata 700064 (India)

    2015-03-15

    The vacuum system of the Room Temperature (K = 130) Cyclotron of Variable Energy Cyclotron Centre is comprised of vacuum systems of main machine and Beam Transport System. The vacuum control system is upgraded to a PLC based Automated system from the initial relay based Manual system. The supervisory control of the vacuum system is implemented in Experimental Physics and Industrial Control System (EPICS). An EPICS embedded ARM based vacuum gauge controller is developed to mitigate the requirement of vendor specific gauge controller for gauges and also for seamless integration of the gauge controllers with the control system. A set of MS-Windows ActiveX components with embedded EPICS Channel Access interface are developed to build operator interfaces with less complex programming and to incorporate typical Windows feature, e.g., user authentication, file handling, better fonts, colors, mouse actions etc. into the operator interfaces. The control parameters, monitoring parameters, and system interlocks of the system are archived in MySQL based EPICS MySQL Archiver developed indigenously. In this paper, we describe the architecture, the implementation details, and the performance of the system.

  19. Implementation of EPICS based vacuum control system for variable energy cyclotron centre, Kolkata

    International Nuclear Information System (INIS)

    Roy, Anindya; Bhole, R. B.; Nandy, Partha P.; Yadav, R. C.; Pal, Sarbajit; Roy, Amitava

    2015-01-01

    The vacuum system of the Room Temperature (K = 130) Cyclotron of Variable Energy Cyclotron Centre is comprised of vacuum systems of main machine and Beam Transport System. The vacuum control system is upgraded to a PLC based Automated system from the initial relay based Manual system. The supervisory control of the vacuum system is implemented in Experimental Physics and Industrial Control System (EPICS). An EPICS embedded ARM based vacuum gauge controller is developed to mitigate the requirement of vendor specific gauge controller for gauges and also for seamless integration of the gauge controllers with the control system. A set of MS-Windows ActiveX components with embedded EPICS Channel Access interface are developed to build operator interfaces with less complex programming and to incorporate typical Windows feature, e.g., user authentication, file handling, better fonts, colors, mouse actions etc. into the operator interfaces. The control parameters, monitoring parameters, and system interlocks of the system are archived in MySQL based EPICS MySQL Archiver developed indigenously. In this paper, we describe the architecture, the implementation details, and the performance of the system

  20. Planning and analyzing clinical trials with composite endpoints

    CERN Document Server

    Rauch, Geraldine; Kieser, Meinhard

    2017-01-01

    This book addresses the most important aspects of how to plan and evaluate clinical trials with a composite primary endpoint to guarantee a clinically meaningful and valid interpretation of the results. Composite endpoints are often used as primary efficacy variables for clinical trials, particularly in the fields of oncology and cardiology. These endpoints combine several variables of interest within a single composite measure, and as a result, all variables that are of major clinical relevance can be considered in the primary analysis without the need to adjust for multiplicity. Moreover, composite endpoints are intended to increase the size of the expected effects thus making clinical trials more powerful. The book offers practical advice for statisticians and medical experts involved in the planning and analysis of clinical trials. For readers who are mainly interested in the application of the methods, all the approaches are illustrated with real-world clinical trial examples, and the software codes requ...

  1. Information on blinding in registered records of clinical trials

    Directory of Open Access Journals (Sweden)

    Viergever Roderik F

    2012-11-01

    Full Text Available Abstract Information on blinding is part of the data that should be provided upon registration of a trial at a clinical trials registry. Reporting of blinding is often absent or of low quality in published articles of clinical trials. This study researched the presence and quality of information on blinding in registered records of clinical trials and highlights the important role of data-recording formats at clinical trial registries in ensuring high-quality registration.

  2. Clinical trial quality: From supervision to collaboration and beyond.

    Science.gov (United States)

    Meeker-O'Connell, Ann; Glessner, Coleen

    2018-02-01

    Over the past decade, clinical trial quality has evolved from an after-the-fact, reactive activity to one focused on the important work of evidence generation from well-designed trials. This article explores the role the Clinical Trials Transformation Initiative has played in advancing quality as a core element of clinical trial design, through project work that initially focused on monitoring but evolved into a holistic, prospective, and comprehensive quality by design approach to clinical trial design and conduct.

  3. A MySQL Based EPICS Archiver

    International Nuclear Information System (INIS)

    Slominski, Christopher

    2009-01-01

    Archiving a large fraction of the EPICS signals within the Jefferson Lab (JLAB) Accelerator control system is vital for postmortem and real-time analysis of the accelerator performance. This analysis is performed on a daily basis by scientists, operators, engineers, technicians, and software developers. Archiving poses unique challenges due to the magnitude of the control system. A MySQL Archiving system (Mya) was developed to scale to the needs of the control system; currently archiving 58,000 EPICS variables, updating at a rate of 11,000 events per second. In addition to the large collection rate, retrieval of the archived data must also be fast and robust. Archived data retrieval clients obtain data at a rate over 100,000 data points per second. Managing the data in a relational database provides a number of benefits. This paper describes an archiving solution that uses an open source database and standard off the shelf hardware to reach high performance archiving needs. Mya has been in production at Jefferson Lab since February of 2007.

  4. A MySQL Based EPICS Archiver

    Energy Technology Data Exchange (ETDEWEB)

    Christopher Slominski

    2009-10-01

    Archiving a large fraction of the EPICS signals within the Jefferson Lab (JLAB) Accelerator control system is vital for postmortem and real-time analysis of the accelerator performance. This analysis is performed on a daily basis by scientists, operators, engineers, technicians, and software developers. Archiving poses unique challenges due to the magnitude of the control system. A MySQL Archiving system (Mya) was developed to scale to the needs of the control system; currently archiving 58,000 EPICS variables, updating at a rate of 11,000 events per second. In addition to the large collection rate, retrieval of the archived data must also be fast and robust. Archived data retrieval clients obtain data at a rate over 100,000 data points per second. Managing the data in a relational database provides a number of benefits. This paper describes an archiving solution that uses an open source database and standard off the shelf hardware to reach high performance archiving needs. Mya has been in production at Jefferson Lab since February of 2007.

  5. Subjective and objective outcomes in randomized clinical trials

    DEFF Research Database (Denmark)

    Moustgaard, Helene; Bello, Segun; Miller, Franklin G

    2014-01-01

    explicitly defined the terms. CONCLUSION: The terms "subjective" and "objective" are ambiguous when used to describe outcomes in randomized clinical trials. We suggest that the terms should be defined explicitly when used in connection with the assessment of risk of bias in a clinical trial......OBJECTIVES: The degree of bias in randomized clinical trials varies depending on whether the outcome is subjective or objective. Assessment of the risk of bias in a clinical trial will therefore often involve categorization of the type of outcome. Our primary aim was to examine how the concepts...... "subjective outcome" and "objective outcome" are defined in methodological publications and clinical trial reports. To put this examination into perspective, we also provide an overview of how outcomes are classified more broadly. STUDY DESIGN AND SETTING: A systematic review of methodological publications...

  6. Existing data sources for clinical epidemiology: Aarhus University Clinical Trial Candidate Database, Denmark.

    Science.gov (United States)

    Nørrelund, Helene; Mazin, Wiktor; Pedersen, Lars

    2014-01-01

    Denmark is facing a reduction in clinical trial activity as the pharmaceutical industry has moved trials to low-cost emerging economies. Competitiveness in industry-sponsored clinical research depends on speed, quality, and cost. Because Denmark is widely recognized as a region that generates high quality data, an enhanced ability to attract future trials could be achieved if speed can be improved by taking advantage of the comprehensive national and regional registries. A "single point-of-entry" system has been established to support collaboration between hospitals and industry. When assisting industry in early-stage feasibility assessments, potential trial participants are identified by use of registries to shorten the clinical trial startup times. The Aarhus University Clinical Trial Candidate Database consists of encrypted data from the Danish National Registry of Patients allowing an immediate estimation of the number of patients with a specific discharge diagnosis in each hospital department or outpatient specialist clinic in the Central Denmark Region. The free access to health care, thorough monitoring of patients who are in contact with the health service, completeness of registration at the hospital level, and ability to link all databases are competitive advantages in an increasingly complex clinical trial environment.

  7. EPICS device support module as ATCA system manager for the ITER fast plant system controller

    Energy Technology Data Exchange (ETDEWEB)

    Carvalho, Paulo F., E-mail: pricardofc@ipfn.ist.utl.pt [Associação EURATOM/IST, Instituto de Plasmas e Fusão Nuclear, Instituto Superior Técnico – Universidade Técnica de Lisboa, Lisboa (Portugal); Santos, Bruno; Gonçalves, Bruno; Carvalho, Bernardo B.; Sousa, Jorge; Rodrigues, A.P.; Batista, António J.N.; Correia, Miguel; Combo, Álvaro [Associação EURATOM/IST, Instituto de Plasmas e Fusão Nuclear, Instituto Superior Técnico – Universidade Técnica de Lisboa, Lisboa (Portugal); Correia, Carlos M.B.A. [Centro de Instrumentação, Departamento de Física, Universidade de Coimbra, Coimbra (Portugal); Varandas, Carlos A.F. [Associação EURATOM/IST, Instituto de Plasmas e Fusão Nuclear, Instituto Superior Técnico – Universidade Técnica de Lisboa, Lisboa (Portugal)

    2013-10-15

    Highlights: ► In Nuclear Fusion, demanding security and high-availability requirements call for redundancy to be available. ► ATCA based Nuclear Fusion Systems are composed by several electronic and mechanical component. ► Control and monitoring of ATCA electronic systems are recommended. ► ITER Fast Plant System Controller Project CODAC system prototype. ► EPICS device support module as External ATCA system manager solution. -- Abstract: This paper presents an Enhanced Physics and Industrial Control System (EPICS) device support module for the International Thermonuclear Experimental Reactor (ITER) Fast Plant System Controller (FPSC) project based in Advanced Telecommunications Computing Architecture (ATCA) specification. The developed EPICS device support module provides an External System Manager (ESM) solution for monitoring and control the ITER FPSC ATCA shelf system and data acquisition boards in order to take proper action and report problems to a control room operator or high level management unit in case of any system failure occurrence. EPICS device support module acts as a Channel Access (CA) server to report problems and publish ATCA system data information to the control room operator, high level management unit or other CA network clients such as Control System Studio Operator Interfaces (CSS OPIs), Best Ever Alarm System Toolkit (BEAST), Best Ever Archive Utility (BEAUTY) or other CA client applications. EPICS device support module communicates with the ATCA Shelf manager (ShM) using HTTP protocol to send and receive commands through POST method in order to get and set system and shelf components properties such as fan speeds measurements, temperatures readings, module status and ATCA boards acquisition and configuration parameters. All system properties, states, commands and parameters are available through the EPICS device support module CA server in EPICS Process Variables (PV) and signals format. ATCA ShM receives the HTTP protocol

  8. Marketing and clinical trials: a case study.

    Science.gov (United States)

    Francis, David; Roberts, Ian; Elbourne, Diana R; Shakur, Haleema; Knight, Rosemary C; Garcia, Jo; Snowdon, Claire; Entwistle, Vikki A; McDonald, Alison M; Grant, Adrian M; Campbell, Marion K

    2007-11-20

    Publicly funded clinical trials require a substantial commitment of time and money. To ensure that sufficient numbers of patients are recruited it is essential that they address important questions in a rigorous manner and are managed well, adopting effective marketing strategies. Using methods of analysis drawn from management studies, this paper presents a structured assessment framework or reference model, derived from a case analysis of the MRC's CRASH trial, of 12 factors that may affect the success of the marketing and sales activities associated with clinical trials. The case study demonstrates that trials need various categories of people to buy in - hence, to be successful, trialists must embrace marketing strategies to some extent. The performance of future clinical trials could be enhanced if trialists routinely considered these factors.

  9. An autonomous observation and control system based on EPICS and RTS2 for Antarctic telescopes

    Science.gov (United States)

    Zhang, Guang-yu; Wang, Jian; Tang, Peng-yi; Jia, Ming-hao; Chen, Jie; Dong, Shu-cheng; Jiang, Fengxin; Wu, Wen-qing; Liu, Jia-jing; Zhang, Hong-fei

    2016-01-01

    For unattended telescopes in Antarctic, the remote operation, autonomous observation and control are essential. An EPICS-(Experimental Physics and Industrial Control System) and RTS2-(Remote Telescope System, 2nd Version) based autonomous observation and control system with remoted operation is introduced in this paper. EPICS is a set of open source software tools, libraries and applications developed collaboratively and used worldwide to create distributed soft real-time control systems for scientific instruments while RTS2 is an open source environment for control of a fully autonomous observatory. Using the advantage of EPICS and RTS2, respectively, a combined integrated software framework for autonomous observation and control is established that use RTS2 to fulfil the function of astronomical observation and use EPICS to fulfil the device control of telescope. A command and status interface for EPICS and RTS2 is designed to make the EPICS IOC (Input/Output Controller) components integrate to RTS2 directly. For the specification and requirement of control system of telescope in Antarctic, core components named Executor and Auto-focus for autonomous observation is designed and implemented with remote operation user interface based on browser-server mode. The whole system including the telescope is tested in Lijiang Observatory in Yunnan Province for practical observation to complete the autonomous observation and control, including telescope control, camera control, dome control, weather information acquisition with the local and remote operation.

  10. Developments in statistical evaluation of clinical trials

    CERN Document Server

    Oud, Johan; Ghidey, Wendimagegn

    2014-01-01

    This book describes various ways of approaching and interpreting the data produced by clinical trial studies, with a special emphasis on the essential role that biostatistics plays in clinical trials. Over the past few decades the role of statistics in the evaluation and interpretation of clinical data has become of paramount importance. As a result the standards of clinical study design, conduct and interpretation have undergone substantial improvement. The book includes 18 carefully reviewed chapters on recent developments in clinical trials and their statistical evaluation, with each chapter providing one or more examples involving typical data sets, enabling readers to apply the proposed procedures. The chapters employ a uniform style to enhance comparability between the approaches.

  11. Ethics of clinical trials.

    Science.gov (United States)

    Palter, S F

    1996-05-01

    The modern clinical trial is a form of human experimentation. There is a long history of disregard for individual rights of the patient in this context, and special attention must be paid to ethical guidelines for these studies. Clinical trials differ in basic ways from clinical practice. Foremost is the introduction of outside interests, beyond those of the patient's health, into the doctor-patient therapeutic alliance. Steps must be taken to protect the interests of the patient when such outside influence exists. Kantian moral theory and the Hippocratic oath dictate that the physician must respect the individual patient's rights and hold such interests paramount. These principles are the basis for informed consent. Randomization of patients is justified when a condition of equipoise exists. The changing nature of health care delivery in the United States introduces new outside interests into the doctor-patient relationship.

  12. Quality of clinical trials: A moving target

    Science.gov (United States)

    Bhatt, Arun

    2011-01-01

    Quality of clinical trials depends on data integrity and subject protection. Globalization, outsourcing and increasing complexicity of clinical trials have made the target of achieving global quality challenging. The quality, as judged by regulatory inspections of the investigator sites, sponsors/contract research organizations and Institutional Review Board, has been of concern to the US Food and Drug Administration, as there has been hardly any change in frequency and nature of common deficiencies. To meet the regulatory expectations, the sponsors need to improve quality by developing systems with specific standards for each clinical trial process. The quality systems include: personnel roles and responsibilities, training, policies and procedures, quality assurance and auditing, document management, record retention, and reporting and corrective and preventive action. With an objective to improve quality, the FDA has planned new inspection approaches such as risk-based inspections, surveillance inspections, real-time oversight, and audit of sponsor quality systems. The FDA has partnered with Duke University for Clinical Trials Transformation Initiative, which will conduct research projects on design principles, data quality and quantity including monitoring, study start-up, and adverse event reporting. These recent initiatives will go a long way in improving quality of clinical trials. PMID:22145122

  13. Epic and Romance in The Lord Of The Rings

    Directory of Open Access Journals (Sweden)

    Martin Simonson

    2016-10-01

    Full Text Available In the field of comparative literature The Lord of the Rings has been most frequently studied within the contexts of romance and epic. This approach, however, leaves out important generic aspects of the global picture, such as the narrative’s strong adherence to the novel genre and to mythic traditions beyond romance and epic narratives. If we choose one particular genre as the yardstick against which to measure the work’s success in narrative terms, we tend to end up with the conclusion that The Lord of the Rings does not quite make sense within the given limits of the genre in question. In Tolkien’s work there is a narrative and stylistic exploration of the different genres’ constraints in which the Western narrative traditions – myth, epic, romance, the novel, and their respective subgenres – interact in a previously unknown but still very much coherent world that, because of the particular cohesion required by such a chronotope, exhibits a clear contextualization of references to the previous traditions. As opposed to many contemporary literary expressions, the ensuing absence of irony and parody creates a generic dialogue, in which the various narrative traditions explore and interrogate each other’s limits without rendering the others absurdly incompatible, ridiculous or superfluous.

  14. Health literacy and usability of clinical trial search engines.

    Science.gov (United States)

    Utami, Dina; Bickmore, Timothy W; Barry, Barbara; Paasche-Orlow, Michael K

    2014-01-01

    Several web-based search engines have been developed to assist individuals to find clinical trials for which they may be interested in volunteering. However, these search engines may be difficult for individuals with low health and computer literacy to navigate. The authors present findings from a usability evaluation of clinical trial search tools with 41 participants across the health and computer literacy spectrum. The study consisted of 3 parts: (a) a usability study of an existing web-based clinical trial search tool; (b) a usability study of a keyword-based clinical trial search tool; and (c) an exploratory study investigating users' information needs when deciding among 2 or more candidate clinical trials. From the first 2 studies, the authors found that users with low health literacy have difficulty forming queries using keywords and have significantly more difficulty using a standard web-based clinical trial search tool compared with users with adequate health literacy. From the third study, the authors identified the search factors most important to individuals searching for clinical trials and how these varied by health literacy level.

  15. Marketing and clinical trials: a case study

    Directory of Open Access Journals (Sweden)

    Entwistle Vikki A

    2007-11-01

    Full Text Available Abstract Background Publicly funded clinical trials require a substantial commitment of time and money. To ensure that sufficient numbers of patients are recruited it is essential that they address important questions in a rigorous manner and are managed well, adopting effective marketing strategies. Methods Using methods of analysis drawn from management studies, this paper presents a structured assessment framework or reference model, derived from a case analysis of the MRC's CRASH trial, of 12 factors that may affect the success of the marketing and sales activities associated with clinical trials. Results The case study demonstrates that trials need various categories of people to buy in – hence, to be successful, trialists must embrace marketing strategies to some extent. Conclusion The performance of future clinical trials could be enhanced if trialists routinely considered these factors.

  16. Inherited Retinal Degenerative Clinical Trial Network. Addendum

    Science.gov (United States)

    2013-10-01

    inherited orphan retinal degenerative diseases and dry age-related macular degeneration (AMD) through the conduct of clinical trials and other...design and conduct of effective and efficient clinical trials for inherited orphan retinal degenerative diseases and dry AMD; • Limited number and...linica l trial in the NEER network for autosomal dominant retinitis pigmentosa, and the ProgSTAR studies for Stargardt disease ) . As new interventions b

  17. Clinical trial participation. Viewpoints from racial/ethnic groups.

    Science.gov (United States)

    Roberson, N L

    1994-11-01

    Racial/ethnic groups' participation in clinical trials is a relatively new area of research that warrants attention. Although racial/ethnic groups have been included in experimental studies since the 1940s, they were not included in significant numbers in clinical trials for cancer. Clinical trials play a dominant role in clinical oncology. Despite this state-of-the-art cancer treatment, however, there is mounting concern that this scientific progress is not being shared equitably by all segments of the U.S. population. There is underrepresentation of members of racial/ethnic groups in cancer clinical trials, which suggests that participation may be a critical issue. Unfortunately, little is known or documented about these groups' participation in clinical trials. This paper discusses racial/ethnic groups' views and opinions about clinical trial participation. Diagnostic research was conducted as a beginning phase to investigate this new area of research. African Americans, Hispanics, and Native Americans in three Buffalo, New York, communities were selected as study subjects. Data were collected via telephone surveys. Qualitative methods were employed for data analysis and reporting. Findings showed that study subjects knew little about cancer clinical trials and basically had no opportunity to participate. They believed that participation in clinical trials could be beneficial. In each of the three groups, however, there were cultural factors believed to influence participation. A primary concern was "mistrust of white people" and the feeling of being treated like "guinea pigs." Based on study findings, it was evident that recruitment for improving participation requires strategic planning that involves participants representative of the study population. To yield results, the plan should be tailored to the target group, presented as a credible study, designed to reflect trust in the medical care team, and implemented through a continuous educational process.

  18. Clinical trials of homoeopathy.

    Science.gov (United States)

    Kleijnen, J; Knipschild, P; ter Riet, G

    1991-01-01

    OBJECTIVE--To establish whether there is evidence of the efficacy of homoeopathy from controlled trials in humans. DESIGN--Criteria based meta-analysis. Assessment of the methodological quality of 107 controlled trials in 96 published reports found after an extensive search. Trials were scored using a list of predefined criteria of good methodology, and the outcome of the trials was interpreted in relation to their quality. SETTING--Controlled trials published world wide. MAIN OUTCOME MEASURES--Results of the trials with the best methodological quality. Trials of classical homoeopathy and several modern varieties were considered separately. RESULTS--In 14 trials some form of classical homoeopathy was tested and in 58 trials the same single homoeopathic treatment was given to patients with comparable conventional diagnosis. Combinations of several homoeopathic treatments were tested in 26 trials; isopathy was tested in nine trials. Most trials seemed to be of very low quality, but there were many exceptions. The results showed a positive trend regardless of the quality of the trial or the variety of homeopathy used. Overall, of the 105 trials with interpretable results, 81 trials indicated positive results whereas in 24 trials no positive effects of homoeopathy were found. The results of the review may be complicated by publication bias, especially in such a controversial subject as homoeopathy. CONCLUSIONS--At the moment the evidence of clinical trials is positive but not sufficient to draw definitive conclusions because most trials are of low methodological quality and because of the unknown role of publication bias. This indicates that there is a legitimate case for further evaluation of homoeopathy, but only by means of well performed trials. PMID:1825800

  19. Recruitment of subjects into clinical trials for Alzheimer disease.

    Science.gov (United States)

    Knebl, Janice A; Patki, Deepti

    2010-09-01

    Alzheimer disease is a devastating neurodegenerative disorder affecting millions of Americans. It reduces the ability of the individual to remain independent, places a burden on caregivers, and substantially increases healthcare costs. New treatments are being tested in numerous clinical trials with the goal of preventing or delaying the onset of Alzheimer disease, slowing or modifying the disease's course, or finding a cure for patients with the disease. Alzheimer disease research can successfully proceed only if individuals who have this illness are willing to participate in clinical trials. However, recruitment and retention of subjects in clinical trials for Alzheimer disease is a challenging task. Furthermore, because of reductions in decision-making capacities of individuals with Alzheimer disease, clinical trials also need to involve caregivers. The present article delineates unique hurdles encountered in the recruitment process for Alzheimer disease clinical trials. The article also identifies strategies for effective recruitment of subjects in Alzheimer disease clinical trials, including guidelines to help principal investigators and clinical research coordinators reach recruitment goals.

  20. Where are clinical trials going? Society and clinical trials.

    Science.gov (United States)

    Sleight, P

    2004-02-01

    Clinical trials now increasingly impinge on society at large. First there is growing emphasis from health organizations on the need for unbiased evidence about the effectiveness of promoted remedies. Second, as most novel treatments accrue increased costs to society, these need to be evaluated in terms of value for money. Third, there has been confusion and concern about the resolution of conflicting evidence, especially the role of advertising and commercial pressures from a powerful pharmaceutical industry motivated by profit. Fourth, there is concern about research fraud and the ethics of clinical trials. Fifth, there is increasing suspicion of political advice, which sometimes has sought to reassure an anxious public on the basis of complex and possibly inadequate scientific information. Some of these issues are addressed by truly independent and properly constituted data and safety monitoring committees, which are of particular importance when academic investigators or universities have a large financial conflict of interest. This is now more problematic with the current encouragement of investigator-led spin-off companies. These issues are best resolved by independent financial support (from government or other institutions) rather than relying on the commercial sponsor.

  1. New EORTC clinical trials for BNCT

    International Nuclear Information System (INIS)

    Hideghety, K.; Moss, R.; Vries, M. de

    2000-01-01

    Due to ethical reasons, a separated optimization of the two components of BNCT in the frame of clinical investigations can only be performed applying the whole binary system. The ongoing trial at HFR (High Flux Reactor Petten) has proven the feasibility of BNCT under defined conditions. On that basis the European Commission supported a comprehensive research project on boron imaging including three further clinical studies. In the first trial the boron uptake related to the blood boron concentration and surrounding normal tissue in various solid tumours will be examined using BSH (Sodiumborocaptate), BPA (Boronophenylalanine) or both in order to explore tumour entities, which may gain benefit from BNCT. The major objectives of the second trial are to define the maximum tolerated single and cumulative dose, and the dose limiting toxicity of BSH. The third clinical trial, a phase II study is designed to evaluate the anti-tumour effect of fractionated BNCT at the Petten treatment facility against cerebral metastasis of malignant melanoma using BPA. (author)

  2. 78 FR 69363 - Lake Tahoe Basin Management Unit, California, Heavenly Mountain Resort Epic Discovery Project

    Science.gov (United States)

    2013-11-19

    ... DEPARTMENT OF AGRICULTURE Forest Service Lake Tahoe Basin Management Unit, California, Heavenly Mountain Resort Epic Discovery Project AGENCY: Lake Tahoe Basin Management Unit, Forest Service, USDA...: The Epic Discovery Project is intended to enhance summer activities in response to the USDA Forest...

  3. Development of Multi-Sensor Global Cloud and Radiance Composites for DSCOVR EPIC Imager with Subpixel Definition

    Science.gov (United States)

    Khlopenkov, K. V.; Duda, D. P.; Thieman, M. M.; Sun-Mack, S.; Su, W.; Minnis, P.; Bedka, K. M.

    2017-12-01

    The Deep Space Climate Observatory (DSCOVR) is designed to study the daytime Earth radiation budget by means of onboard Earth Polychromatic Imaging Camera (EPIC) and National Institute of Standards and Technology Advanced Radiometer (NISTAR). EPIC imager observes in several shortwave bands (317-780 nm), while NISTAR measures the top-of-atmosphere (TOA) whole-disk radiance in shortwave and total broadband windows. Calculation of albedo and outgoing longwave flux requires a high-resolution scene identification such as the radiance observations and cloud property retrievals from low earth orbit and geostationary satellite imagers. These properties have to be co-located with EPIC imager pixels to provide scene identification and to select anisotropic directional models, which are then used to adjust the NISTAR-measured radiance and subsequently obtain the global daytime shortwave and longwave fluxes. This work presents an algorithm for optimal merging of selected radiances and cloud properties derived from multiple satellite imagers to obtain seamless global hourly composites at 5-km resolution. The highest quality observation is selected by means of an aggregated rating which incorporates several factors such as the nearest time relative to EPIC observation, lowest viewing zenith angle, and others. This process provides a smoother transition and avoids abrupt changes in the merged composite data. Higher spatial accuracy in the composite product is achieved by using the inverse mapping with gradient search during reprojection and bicubic interpolation for pixel resampling. The composite data are subsequently remapped into the EPIC-view domain by convolving composite pixels with the EPIC point spread function (PSF) defined with a half-pixel accuracy. Within every EPIC footprint, the PSF-weighted average radiances and cloud properties are computed for each cloud phase and then stored within five data subsets (clear-sky, water cloud, ice cloud, total cloud, and no

  4. Contribution of clinical trials to gross domestic product in Hungary.

    Science.gov (United States)

    Kaló, Zoltán; Antal, János; Pénzes, Miklós; Pozsgay, Csilla; Szepezdi, Zsuzsanna; Nagyjánosi, László

    2014-10-01

    To determine the contribution of clinical trials to the gross domestic product (GDP) in Hungary. An anonymous survey of pharmaceutical companies and clinical research organizations (CROs) was conducted to estimate their clinical trial-related employment and revenues. Clinical trial documents at the National Institute of Pharmacy (NIP) were analyzed to estimate trial-related revenues at health care institutions and the value of investigational medical products (IMPs) based on avoided drug costs. Financial benefits were calculated as 2010 US $ purchasing power parity (PPP) values. Clinical trials increased the revenue of Hungarian health care providers by 1 US $65.6 million. The value of IMPs was US $67.0 million. Clinical trial operation and management activities generated 900 jobs and US $166.9 million in revenue among CROs and pharmaceutical companies. The contribution of clinical trials to the Hungarian GDP in 2010 amounted to 0.2%. Participation in international clinical trials may result in health, financial, and intangible benefits that contribute to the sustainability of health care systems, especially in countries with severe resource constraints. Although a conservative approach was employed to estimate the economic benefits of clinical trials, further research is necessary to improve the generalizability of our findings.

  5. Real-time enrollment dashboard for multisite clinical trials

    Directory of Open Access Journals (Sweden)

    William A. Mattingly

    2015-10-01

    Conclusion: We have designed and implemented a visualization dashboard for managing multi-site clinical trial enrollment in two community acquired pneumonia studies. Information dashboards are useful for clinical trial management. They can be used in a standalone trial or can be included into a larger management system.

  6. [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.

  7. Potential substitution of mineral P fertilizer by manure: EPIC development and implementation

    Science.gov (United States)

    Azevedo, Ligia B.; Vadas, Peter A.; Balkovič, Juraj; Skalský, Rastislav; Folberth, Christian; van der Velde, Marijn; Obersteiner, Michael

    2016-04-01

    Sources of mineral phosphorus (P) fertilizers are non-renewable. Although the longevity of P mines and the risk of future P depletion are highly debated P scarcity may be detrimental to agriculture in various ways. Some of these impacts include increasing food insecurity and nitrogen (N) and P imbalances, serious fluctuations in the global fertilizer and crop market prices, and contribution in geopolitical conflicts. P-rich waste produced from livestock production activities (i.e. manure) are an alternative to mineral P fertilizer. The substitution of mineral fertilizer with manure (1) delays the depletion of phosphate rock stocks, (2) reduces the vulnerability of P fertilizer importing countries to sudden changes in the fertilizer market, (3) reduces the chances of geopolitical conflicts arising from P exploitation pressures, (4) avoids the need for environmental protection policies in livestock systems, (5) is an opportunity for the boosting of crop yields in low nutrient input agricultural systems, and (6) contributes to the inflow of not only P but also other essential nutrients to agricultural soils. The Environmental Policy Integrated Climate model (EPIC) is a widely used process-based, crop model integrating various environmental flows relevant to crop production as well as environmental quality assessments. We simulate crop yields using a powerful computer cluster infra-structure (known as EPIC-IIASA) in combination with spatially-explicit EPIC input data on climate, management, soils, and landscape. EPIC-IIASA contains over 131,000 simulation units and it has 5 arc-min resolution. In this work, we implement two process-based models of manure biogeochemistry into EPIC-IIASA, i.e. SurPhos (for P) and Manure DNDC (for N and carbon) and a fate model model describing nutrient outflows from fertilizer via runoff. For EGU, we will use EPIC-IIASA to quantify the potential of mineral P fertilizer substitution with manure. Specifically, we will estimate the relative

  8. Monitoring commercial conventional facilities control with the APS control system: The Metasys-to-EPICS interface

    International Nuclear Information System (INIS)

    Nawrocki, G.J.; Seaver, C.L.; Kowalkowski, J.B.

    1995-01-01

    As controls needs at the Advanced Photon Source matured from an installation phase to an operational phase, the need to monitor the existing conventional facilities control system with the EPICS-based accelerator control system was realized. This existing conventional facilities control network is based on a proprietary system from Johnson Controls called Metasys. Initially read-only monitoring of the Metasys parameters will be provided; however, the ability for possible future expansion to full control is available. This paper describes a method of using commercially available hardware and existing EPICS software as a bridge between the Metasys and EPICS control systems

  9. Real-Time Enrollment Dashboard For Multisite Clinical Trials.

    Science.gov (United States)

    Mattingly, William A; Kelley, Robert R; Wiemken, Timothy L; Chariker, Julia H; Peyrani, Paula; Guinn, Brian E; Binford, Laura E; Buckner, Kimberley; Ramirez, Julio

    2015-10-30

    Achieving patient recruitment goals are critical for the successful completion of a clinical trial. We designed and developed a web-based dashboard for assisting in the management of clinical trial screening and enrollment. We use the dashboard to assist in the management of two observational studies of community-acquired pneumonia. Clinical research associates and managers using the dashboard were surveyed to determine its effectiveness as compared with traditional direct communication. The dashboard has been in use since it was first introduced in May of 2014. Of the 23 staff responding to the survey, 77% felt that it was easier or much easier to use the dashboard for communication than to use direct communication. We have designed and implemented a visualization dashboard for managing multi-site clinical trial enrollment in two community acquired pneumonia studies. Information dashboards are a useful tool for clinical trial management. They can be used as a standalone trial information tool or included into a larger management system.

  10. Gene therapy clinical trials worldwide to 2017: An update.

    Science.gov (United States)

    Ginn, Samantha L; Amaya, Anais K; Alexander, Ian E; Edelstein, Michael; Abedi, Mohammad R

    2018-03-25

    To date, almost 2600 gene therapy clinical trials have been completed, are ongoing or have been approved worldwide. Our database brings together global information on gene therapy clinical activity from trial databases, official agency sources, published literature, conference presentations and posters kindly provided to us by individual investigators or trial sponsors. This review presents our analysis of clinical trials that, to the best of our knowledge, have been or are being performed worldwide. As of our November 2017 update, we have entries on 2597 trials undertaken in 38 countries. We have analysed the geographical distribution of trials, the disease indications (or other reasons) for trials, the proportions to which different vector types are used, and the genes that have been transferred. Details of the analyses presented, and our searchable database are available via The Journal of Gene Medicine Gene Therapy Clinical Trials Worldwide website at: http://www.wiley.co.uk/genmed/clinical. We also provide an overview of the progress being made in gene therapy clinical trials around the world, and discuss key trends since the previous review, namely the use of chimeric antigen receptor T cells for the treatment of cancer and advancements in genome editing technologies, which have the potential to transform the field moving forward. Copyright © 2018 John Wiley & Sons, Ltd.

  11. 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.

  12. 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

  13. Organisation of a clinical trial unit--a proposal

    DEFF Research Database (Denmark)

    Gluud, C; Sørensen, T I

    1998-01-01

    to cover investments, core staff, and running costs, but excluding housing costs and costs of randomised clinical trials that do not originate from trial coordination. In return, such a unit should be able to mount and launch 6-7 multicenter randomised clinical trials during a 5 year period, corresponding...

  14. [Is the socioeconomic deprivation EPICES score useful in obstetrics?].

    Science.gov (United States)

    Convers, M; Langeron, A; Sass, C; Moulin, J-J; Augier, A; Varlet, M-N; Seffert, P; Chêne, G

    2012-04-01

    To describe a validated and multifactorial deprivation score to study the relationship between socioeconomic deprivation and perinatal risks. The index of deprivation EPICES (Evaluation of Precarity and Inequalities in Health Examination Centers) was used to characterize the deprivation status of 234 women in post-partum in comparison with perinatal morbidity. The cutoff value of 30.7 was the threshold to define deprivation. Two hundred and eight patients were included in this retrospective study from whom 48 (23%) had a score of deprivation higher than 30.7. Maternofetal morbidity was more severe in deprived patients. The current results show that the EPICES score could be a useful obstetrical tool for the identification of deprived women during pregnancy. Copyright © 2011 Elsevier Masson SAS. All rights reserved.

  15. Quality of clinical trials: A moving target

    Directory of Open Access Journals (Sweden)

    Arun Bhatt

    2011-01-01

    Full Text Available Quality of clinical trials depends on data integrity and subject protection. Globalization, outsourcing and increasing complexicity of clinical trials have made the target of achieving global quality challenging. The quality, as judged by regulatory inspections of the investigator sites, sponsors/contract research organizations and Institutional Review Board, has been of concern to the US Food and Drug Administration, as there has been hardly any change in frequency and nature of common deficiencies. To meet the regulatory expectations, the sponsors need to improve quality by developing systems with specific standards for each clinical trial process. The quality systems include: personnel roles and responsibilities, training, policies and procedures, quality assurance and auditing, document management, record retention, and reporting and corrective and preventive action. With an objective to improve quality, the FDA has planned new inspection approaches such as risk-based inspections, surveillance inspections, real-time oversight, and audit of sponsor quality systems. The FDA has partnered with Duke University for Clinical Trials Transformation Initiative, which will conduct research projects on design principles, data quality and quantity including monitoring, study start-up, and adverse event reporting. These recent initiatives will go a long way in improving quality of clinical trials.

  16. Advances in Clinical Cardiology 2016: A Summary of the Key Clinical Trials.

    Science.gov (United States)

    Gray, Alastair; McQuillan, Conor; Menown, Ian B A

    2017-07-01

    The findings of many new cardiology clinical trials over the last year have been published or presented at major international meetings. This paper aims to describe and place in context a summary of the key clinical trials in cardiology presented between January and December 2016. The authors reviewed clinical trials presented at major cardiology conferences during 2016 including the American College of Cardiology (ACC), European Association for Percutaneous Cardiovascular Interventions (EuroPCR), European Society of Cardiology (ESC), European Association for the Study of Diabetes (EASD), Transcatheter Cardiovascular Therapeutics (TCT), and the American Heart Association (AHA). Selection criteria were trials with a broad relevance to the cardiology community and those with potential to change current practice. A total of 57 key cardiology clinical trials were identified for inclusion. Here we describe and place in clinical context the key findings of new data relating to interventional and structural cardiology including delayed stenting following primary angioplasty, contrast-induced nephropathy, management of jailed wires, optimal duration of dual antiplatelet therapy (DAPT), stenting vs bypass for left main disease, new generation stents (BioFreedom, Orsiro, Absorb), transcatheter aortic valve implantation (Edwards Sapien XT, transcatheter embolic protection), and closure devices (Watchman, Amplatzer). New preventative cardiology data include trials of bariatric surgery, empagliflozin, liraglutide, semaglutide, PCSK9 inhibitors (evolocumab and alirocumab), and inclisiran. Antiplatelet therapy trials include platelet function monitoring and ticagrelor vs clopidogrel for peripheral vascular disease. New data are also presented in fields of heart failure (sacubitril/valsartan, aliskiren, spironolactone), atrial fibrillation (rivaroxaban in patients undergoing coronary intervention, edoxaban in DC cardioversion), cardiac devices (implantable cardioverter

  17. Critical concepts in adaptive clinical trials

    Directory of Open Access Journals (Sweden)

    Park JJH

    2018-03-01

    Full Text Available Jay JH Park,1 Kristian Thorlund,2,3 Edward J Mills2,3 1Department of Medicine, University of British Columbia, Vancouver, BC, Canada; 2Department of Health Research Methods, Evidence, and Impact (HEI, McMaster University, Hamilton, ON, Canada; 3The Bill and Melinda Gates Foundation, Seattle, WA, USA Abstract: Adaptive clinical trials are an innovative trial design aimed at reducing resources, decreasing time to completion and number of patients exposed to inferior interventions, and improving the likelihood of detecting treatment effects. The last decade has seen an increasing use of adaptive designs, particularly in drug development. They frequently differ importantly from conventional clinical trials as they allow modifications to key trial design components during the trial, as data is being collected, using preplanned decision rules. Adaptive designs have increased likelihood of complexity and also potential bias, so it is important to understand the common types of adaptive designs. Many clinicians and investigators may be unfamiliar with the design considerations for adaptive designs. Given their complexities, adaptive trials require an understanding of design features and sources of bias. Herein, we introduce some common adaptive design elements and biases and specifically address response adaptive randomization, sample size reassessment, Bayesian methods for adaptive trials, seamless trials, and adaptive enrichment using real examples. Keywords: adaptive designs, response adaptive randomization, sample size reassessment, Bayesian adaptive trials, seamless trials, adaptive enrichment

  18. Assessing the readability of ClinicalTrials.gov.

    Science.gov (United States)

    Wu, Danny T Y; Hanauer, David A; Mei, Qiaozhu; Clark, Patricia M; An, Lawrence C; Proulx, Joshua; Zeng, Qing T; Vydiswaran, V G Vinod; Collins-Thompson, Kevyn; Zheng, Kai

    2016-03-01

    ClinicalTrials.gov serves critical functions of disseminating trial information to the public and helping the trials recruit participants. This study assessed the readability of trial descriptions at ClinicalTrials.gov using multiple quantitative measures. The analysis included all 165,988 trials registered at ClinicalTrials.gov as of April 30, 2014. To obtain benchmarks, the authors also analyzed 2 other medical corpora: (1) all 955 Health Topics articles from MedlinePlus and (2) a random sample of 100,000 clinician notes retrieved from an electronic health records system intended for conveying internal communication among medical professionals. The authors characterized each of the corpora using 4 surface metrics, and then applied 5 different scoring algorithms to assess their readability. The authors hypothesized that clinician notes would be most difficult to read, followed by trial descriptions and MedlinePlus Health Topics articles. Trial descriptions have the longest average sentence length (26.1 words) across all corpora; 65% of their words used are not covered by a basic medical English dictionary. In comparison, average sentence length of MedlinePlus Health Topics articles is 61% shorter, vocabulary size is 95% smaller, and dictionary coverage is 46% higher. All 5 scoring algorithms consistently rated CliniclTrials.gov trial descriptions the most difficult corpus to read, even harder than clinician notes. On average, it requires 18 years of education to properly understand these trial descriptions according to the results generated by the readability assessment algorithms. Trial descriptions at CliniclTrials.gov are extremely difficult to read. Significant work is warranted to improve their readability in order to achieve CliniclTrials.gov's goal of facilitating information dissemination and subject recruitment. Published by Oxford University Press on behalf of the American Medical Informatics Association 2015. This work is written by US Government

  19. Clinical Trials Management | Division of Cancer Prevention

    Science.gov (United States)

    Information for researchers about developing, reporting, and managing NCI-funded cancer prevention clinical trials. Protocol Information Office The central clearinghouse for clinical trials management within the Division of Cancer Prevention.Read more about the Protocol Information Office. | Information for researchers about developing, reporting, and managing NCI-funded

  20. Learning from hackers: open-source clinical trials.

    Science.gov (United States)

    Dunn, Adam G; Day, Richard O; Mandl, Kenneth D; Coiera, Enrico

    2012-05-02

    Open sharing of clinical trial data has been proposed as a way to address the gap between the production of clinical evidence and the decision-making of physicians. A similar gap was addressed in the software industry by their open-source software movement. Here, we examine how the social and technical principles of the movement can guide the growth of an open-source clinical trial community.

  1. POPULARIZING EPIC NARRATIVE IN GEORGE R.R. MARTIN'S A GAME OF THRONES

    Directory of Open Access Journals (Sweden)

    Ida Rochani Adi

    2012-11-01

    Full Text Available This research is intended to show the sustainability of epic in latest years of human history through the most phenomenal fantasy in American literature, A Game of Thrones. Along with the capability of human beings in thinking dearly and sensibly, it is commonsensical that people tend to free themselves from irrationality. The reality shows, however, that the existence of epic fantasy still has power in appealing audiences or readers. This is the case with A Game of Thrones written by George RR Martin who was given the award of One of The Most Influential People in 2011 by Time magazine. This qualitative march, using genre approach, finds out that in order to be compatible with today's society, an epic seen in A Game of Thrones, which is commonly known as a story centering on the legendary hero and his heroic deed in oral folk tradition, keeps its power as an epic fantasy narrative through certain archetypes and formulas. Through genre analysis using semiotic approach, the research brings about conclusions that the elements of high fantasy, elements built through rational representation, and a smart combination of convention and invention brings about its popularity. It is also concluded that there is a close relationship between the myth and the mode of people living even in the most modern context.

  2. Smart Technology in Lung Disease Clinical Trials.

    Science.gov (United States)

    Geller, Nancy L; Kim, Dong-Yun; Tian, Xin

    2016-01-01

    This article describes the use of smart technology by investigators and patients to facilitate lung disease clinical trials and make them less costly and more efficient. By "smart technology" we include various electronic media, such as computer databases, the Internet, and mobile devices. We first describe the use of electronic health records for identifying potential subjects and then discuss electronic informed consent. We give several examples of using the Internet and mobile technology in clinical trials. Interventions have been delivered via the World Wide Web or via mobile devices, and both have been used to collect outcome data. We discuss examples of new electronic devices that recently have been introduced to collect health data. While use of smart technology in clinical trials is an exciting development, comparison with similar interventions applied in a conventional manner is still in its infancy. We discuss advantages and disadvantages of using this omnipresent, powerful tool in clinical trials, as well as directions for future research. Published by Elsevier Inc.

  3. Biopharmaceutical industry-sponsored global clinical trials in emerging countries.

    Science.gov (United States)

    Alvarenga, Lenio Souza; Martins, Elisabeth Nogueira

    2010-01-01

    To evaluate biopharmaceutical industry-sponsored clinical trials placed in countries previously described as emerging regions for clinical research, and potential differences for those placed in Brazil. Data regarding recruitment of subjects for clinical trials were retrieved from www.clinicaltrials.gov on February 2nd 2009. Proportions of sites in each country were compared among emerging countries. Multiple logistic regressions were performed to evaluate whether trial placement in Brazil could be predicted by trial location in other countries and/or by trial features. A total of 8,501 trials were then active and 1,170 (13.8%) included sites in emerging countries (i.e., Argentina, Brazil, China, Czech Republic, Hungary, India, Mexico, Poland, Russia, South Korea, and South Africa). South Korea and China presented a significantly higher proportion of sites when compared to other countries (pattractiveness for biopharmaceutical industry-sponsored clinical trials.

  4. Quantitative food intake in the EPIC-Germany cohorts. European Investigation into Cancer and Nutrition.

    Science.gov (United States)

    Schulze, M B; Brandstetter, B R; Kroke, A; Wahrendorf, J; Boeing, H

    1999-01-01

    The EPIC-Heidelberg and the EPIC-Potsdam studies with about 53,000 study participants represent the German contribution to the EPIC (European Investigation into Cancer and Nutrition) cohort study. Within the EPIC study, standardized 24-hour dietary recalls were applied as a quantitative calibration method in order to estimate the amount of scaling bias introduced by the varying center-specific dietary assessment methods. This article presents intake of food items and food groups in the two German cohorts estimated by 24-hour quantitative dietary recalls. Recalls from 1,013 men and 1,078 women in Heidelberg and 1,032 men and 898 women in Potsdam were included in the analysis. The intake of recorded food items or recipe ingredients as well as fat used for cooking was summarized into 16 main food groups and a variety of different subgroups stratified by sex and weighted for the day of the week and age. In more than 90% of the recalls, consumption of dairy products, cereals and cereal products, bread, fat, and non-alcoholic beverages, particularly coffee/tea, was reported. Inter-cohort evaluations revealed that bread, potatoes, fruit and fat were consumed in higher amounts in the Potsdam cohort while the opposite was found for pasta/rice, non-alcoholic, and alcoholic beverages. It was concluded that the exposure variation was increased by having two instead of one EPIC study centers in Germany. Copyright 1999 S. Karger AG, Basel

  5. Involving South Asian patients in clinical trials.

    Science.gov (United States)

    Hussain-Gambles, M; Leese, B; Atkin, K; Brown, J; Mason, S; Tovey, P

    2004-10-01

    To investigate how South Asian patients conceptualise the notion of clinical trials and to identify key processes that impact on trial participation and the extent to which communication difficulties, perceptions of risk and attitudes to authority influence these decisions. Also to identify whether 'South Asian' patients are homogeneous in these issues, and which factors differ between different South Asian subgroups and finally how professionals regard the involvement of South Asian patients and their views on strategies to increase participation. A review of the literature on minority ethnic participation in clinical trials was followed by three qualitative interview studies. Interviews were taped and transcribed (and translated if required) and subjected to framework analysis. Face-to-face interviews were conducted with 25 health professionals; 60 South Asian lay people who had not taken part in a trial and 15 South Asian trial participants. Motivations for trial participation were identified as follows: to help society, to improve own health or that of family and friends, out of obligation to the doctor and to increase scientific knowledge. Deterrents were concerns about drug side-effects, busy lifestyles, language, previous bad experiences, mistrust and feelings of not belonging to British society. There was no evidence of antipathy amongst South Asians to the concept of clinical trials and, overall, the younger respondents were more knowledgeable than the older ones. Problems are more likely to be associated with service delivery. Lack of being approached was a common response. Lay-reported factors that might affect South Asian participation in clinical trials include age, language, social class, feeling of not belonging/mistrust, culture and religion. Awareness of clinical trials varied between each group. There are more similarities than differences in attitudes towards clinical trial participation between the South Asian and the general population

  6. Cancer clinical trials in persons with HIV infection.

    Science.gov (United States)

    Little, Richard F

    2017-01-01

    The era of modern HIV therapeutics is well underway. The cancer and infectious disease epidemiology of HIV disease has markedly altered as populations are availed to the benefits of antiretroviral therapy (ARV). The types of cancers occurring among those with HIV infection has broadened but the case burden in absolute numbers is very low relative to the background population. There are fewer incident cases of the AIDS-defining cancers (aggressive B-cell lymphomas, Kaposi's sarcoma, and cervical cancer). There is an increased risk for certain non-AIDS-defining cancers, but these occur somewhat sporadically relative to clinical trial enrollment. The changing epidemiology of cancer in HIV poses challenges as well as opportunities for participation of persons with HIV in cancer therapy clinical trials. There are excellent examples of cancer trials that inform cancer therapy for patients with HIV infection. Examples include those from HIV-specific trials and from trials mainly focused on the background population that included patients with HIV infection. Interpretation of clinical trials to guide therapy for those with HIV infection and cancer largely depends on data that does not include HIV-infected patients. The ability to extend clinical trial findings to populations not included in clinical trials remains problematic for a variety of populations, including those with HIV or AIDS. Careful prioritization of studies designed to bridge this gap is needed. However, there are published studies that serve as excellent examples bridging these gaps and the portfolio of cancer therapy trials underway will inform HIV and cancer better than at any time in the past.

  7. Are You "Tilting at Windmills" or Undertaking a Valid Clinical Trial?

    Science.gov (United States)

    Zariffa, Jose; Kramer, John L.K.

    2011-01-01

    In this review, several aspects surrounding the choice of a therapeutic intervention and the conduct of clinical trials are discussed. Some of the background for why human studies have evolved to their current state is also included. Specifically, the following questions have been addressed: 1) What criteria should be used to determine whether a scientific discovery or invention is worthy of translation to human application? 2) What recent scientific advance warrants a deeper understanding of clinical trials by everyone? 3) What are the different types and phases of a clinical trial? 4) What characteristics of a human disorder should be noted, tracked, or stratified for a clinical trial and what inclusion /exclusion criteria are important to enrolling appropriate trial subjects? 5) What are the different study designs that can be used in a clinical trial program? 6) What confounding factors can alter the accurate interpretation of clinical trial outcomes? 7) What are the success rates of clinical trials and what can we learn from previous clinical trials? 8) What are the essential principles for the conduct of valid clinical trials? PMID:21786433

  8. Clinical trials of CAR-T cells in China.

    Science.gov (United States)

    Liu, Bingshan; Song, Yongping; Liu, Delong

    2017-10-23

    Novel immunotherapeutic agents targeting tumor-site microenvironment are revolutionizing cancer therapy. Chimeric antigen receptor (CAR)-engineered T cells are widely studied for cancer immunotherapy. CD19-specific CAR-T cells, tisagenlecleucel, have been recently approved for clinical application. Ongoing clinical trials are testing CAR designs directed at novel targets involved in hematological and solid malignancies. In addition to trials of single-target CAR-T cells, simultaneous and sequential CAR-T cells are being studied for clinical applications. Multi-target CAR-engineered T cells are also entering clinical trials. T cell receptor-engineered CAR-T and universal CAR-T cells represent new frontiers in CAR-T cell development. In this study, we analyzed the characteristics of CAR constructs and registered clinical trials of CAR-T cells in China and provided a quick glimpse of the landscape of CAR-T studies in China.

  9. Uncertainties in cloud phase and optical thickness retrievals from the Earth Polychromatic Imaging Camera (EPIC).

    Science.gov (United States)

    Meyer, Kerry; Yang, Yuekui; Platnick, Steven

    2016-01-01

    This paper presents an investigation of the expected uncertainties of a single channel cloud optical thickness (COT) retrieval technique, as well as a simple cloud temperature threshold based thermodynamic phase approach, in support of the Deep Space Climate Observatory (DSCOVR) mission. DSCOVR cloud products will be derived from Earth Polychromatic Imaging Camera (EPIC) observations in the ultraviolet and visible spectra. Since EPIC is not equipped with a spectral channel in the shortwave or mid-wave infrared that is sensitive to cloud effective radius (CER), COT will be inferred from a single visible channel with the assumption of appropriate CER values for liquid and ice phase clouds. One month of Aqua MODIS daytime granules from April 2005 is selected for investigating cloud phase sensitivity, and a subset of these granules that has similar EPIC sun-view geometry is selected for investigating COT uncertainties. EPIC COT retrievals are simulated with the same algorithm as the operational MODIS cloud products (MOD06), except using fixed phase-dependent CER values. Uncertainty estimates are derived by comparing the single channel COT retrievals with the baseline bi-spectral MODIS retrievals. Results show that a single channel COT retrieval is feasible for EPIC. For ice clouds, single channel retrieval errors are minimal (< 2%) due to the particle size insensitivity of the assumed ice crystal (i.e., severely roughened aggregate of hexagonal columns) scattering properties at visible wavelengths, while for liquid clouds the error is mostly limited to within 10%, although for thin clouds (COT < 2) the error can be higher. Potential uncertainties in EPIC cloud masking and cloud temperature retrievals are not considered in this study.

  10. Factors Contributing to Exacerbating Vulnerabilities in Global Clinical Trials

    Science.gov (United States)

    da Silva, Ricardo E.; Amato, Angélica A.; Guilhem, Dirce B.; de Carvalho, Marta R.; Lima, Elisangela da C.; Novaes, Maria Rita C. G.

    2018-01-01

    Background: Although policies and guidelines make use of the concept of vulnerability, few define it. The European Union's directive for clinical trials does not include explanations for or the reasoning behind the designation of certain groups as vulnerable. Emerging economies from lower middle-income countries have, in recent years, had the largest average annual growth rate, as well as increase, in number of clinical trials registered in the US government's database. Nevertheless, careful supervision of research activities has to be ensured. Objective: To describe and analyze the features of the clinical trials involving vulnerable populations in various countries classified by development status and geographic region. Methods: Retrospective study that involved analysis of data obtained from the International Clinical Trials Registry Platform (ICTRP) database between 01/2014 and 12/2014 from countries with (i) highest trial densities during 2005 to 2012, (ii) highest average growth rate in clinical trials, and (iii) greatest trial capabilities. Results: Statistical analysis of this study showed that patients incapable of giving consent personally are 11.4 times more likely to be vulnerable patients than patients who are capable, and that patients in upper-middle-income countries are 1.7 times more likely to be vulnerable patients than patients from high-income countries when participating in global clinical trials. Malaysia (21%), Egypt (20%), Turkey (19%), Israel (18%), and Brazil (17%) had the highest percentages of vulnerable populations involving children. Conclusions: Although the inability to provide consent personally was a factor associated with vulnerability, arbitrary criteria may have been considered when classifying the populations of clinical trials as vulnerable. The EU Clinical Trials Register should provide guidance regarding exactly what aspects or factors should be taken into account to frame given populations as vulnerable, because

  11. Future vision for the quality assurance of oncology clinical trials

    Directory of Open Access Journals (Sweden)

    Thomas eFitzGerald, MD

    2013-03-01

    Full Text Available The National Cancer Institute clinical cooperative groups have been instrumental over the past 50 years in developing clinical trials and evidence based process improvements for clinical oncology patient care. The cooperative groups are undergoing a transformation process as we further integrate molecular biology into personalized patient care and move to incorporate international partners in clinical trials. To support this vision, data acquisition and data management informatics tools must become both nimble and robust to support transformational research at an enterprise level. Information, including imaging, pathology, molecular biology, radiation oncology, surgery, systemic therapy and patient outcome data needs to be integrated into the clinical trial charter using adaptive clinical trial mechanisms for design of the trial. This information needs to be made available to investigators using digital processes for real time data analysis. Future clinical trials will need to be designed and completed in a timely manner facilitated by nimble informatics processes for data management. This paper discusses both past experience and future vision for clinical trials as we move to develop data management and quality assurance processes to meet the needs of the modern trial.

  12. Clinical trials: bringing research to the bedside.

    Science.gov (United States)

    Arvay, C A

    1991-02-01

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

  13. The Landscape of Clinical Trials Evaluating the Theranostic Role of PET Imaging in Oncology: Insights from an Analysis of ClinicalTrials.gov Database

    Science.gov (United States)

    Chen, Yu-Pei; Lv, Jia-Wei; Liu, Xu; Zhang, Yuan; Guo, Ying; Lin, Ai-Hua; Sun, Ying; Mao, Yan-Ping; Ma, Jun

    2017-01-01

    In the war on cancer marked by personalized medicine, positron emission tomography (PET)-based theranostic strategy is playing an increasingly important role. Well-designed clinical trials are of great significance for validating the PET applications and ensuring evidence-based cancer care. This study aimed to provide a comprehensive landscape of the characteristics of PET clinical trials using the substantial resource of ClinicalTrials.gov database. We identified 25,599 oncology trials registered with ClinicalTrials.gov in the last ten-year period (October 2005-September 2015). They were systematically reviewed to validate classification into 519 PET trials and 25,080 other oncology trials used for comparison. We found that PET trials were predominantly phase 1-2 studies (86.2%) and were more likely to be single-arm (78.9% vs. 57.9%, P oncology trials. Furthermore, PET trials were small in scale, generally enrolling fewer than 100 participants (20.3% vs. 25.7% for other oncology trials, P = 0.014), which might be too small to detect a significant theranostic effect. The funding support from industry or National Institutes of Health shrunk over time (both decreased by about 5%), and PET trials were more likely to be conducted in only one region lacking international collaboration (97.0% vs. 89.3% for other oncology trials, P oncology are not receiving the attention or efforts necessary to generate high-quality evidence. Advancing the clinical application of PET imaging will require a concerted effort to improve the quality of trials. PMID:28042342

  14. Soft real-time EPICS extensions for fast control: A case study applied to a TCV equilibrium algorithm

    International Nuclear Information System (INIS)

    Castro, R.; Romero, J.A.; Vega, J.; Nieto, J.; Ruiz, M.; Sanz, D.; Barrera, E.; De Arcas, G.

    2014-01-01

    Highlights: • Implementation of a soft real-time control system based on EPICS technology. • High data throughput system control implementation. • GPU technology applied to fast control. • EPICS fast control based solution. • Fast control and data acquisition in Linux. - Abstract: For new control systems development, ITER distributes CODAC Core System that is a software package based on Linux RedHat, and includes EPICS (Experimental Physics and Industrial Control System) as software control system solution. EPICS technology is being widely used for implementing control systems in research experiments and it is a very well tested technology, but presents important lacks to meet fast control requirements. To manage and process massive amounts of acquired data, EPICS requires additional functions such as: data block oriented transmissions, links with speed-optimized data buffers and synchronization mechanisms not based on system interruptions. This EPICS limitation turned out clearly during the development of the Fast Plant System Controller Prototype for ITER based on PXIe platform. In this work, we present a solution that, on the one hand, is completely compatible and based on EPCIS technology, and on the other hand, extends EPICS technology for implementing high performance fast control systems with soft-real time characteristics. This development includes components such as: data acquisition, processing, monitoring, data archiving, and data streaming (via network and shared memory). Additionally, it is important to remark that this system is compatible with multiple Graphics Processing Units (GPUs) and is able to integrate MatLab code through MatLab engine connections. It preserves EPICS modularity, enabling system modification or extension with a simple change of configuration, and finally it enables parallelization based on data distribution to different processing components. With the objective of illustrating the presented solution in an actual

  15. Disclosure of investigators' recruitment performance in multicenter clinical trials

    DEFF Research Database (Denmark)

    Dal-Ré, Rafael; Moher, David; Gluud, Christian

    2011-01-01

    Rafael Dal-Ré and colleagues argue that the recruitment targets and performance of all site investigators in multi-centre clinical trials should be disclosed in trial registration sites before a trial starts, and when it ends.......Rafael Dal-Ré and colleagues argue that the recruitment targets and performance of all site investigators in multi-centre clinical trials should be disclosed in trial registration sites before a trial starts, and when it ends....

  16. Knowledge and skills of cancer clinical trials nurses in Australia.

    Science.gov (United States)

    Scott, Kathleen; White, Kate; Johnson, Catherine; Roydhouse, Jessica K

    2012-05-01

      This paper is a report of the development and testing of a questionnaire measuring knowledge and skills of cancer clinical trials nurse in Australia.   The role of cancer clinical trials nurse, widely acknowledged as an integral member of the clinical research team, has evolved in recent years. Elements of the clinical trials nurse role in cancer have previously been described. To evaluate specific cancer clinical trials nurse educational and training needs, the development of a valid and reliable tool is required.   In 2009, a study was conducted in three stages. Stage I: questionnaire development and pilot testing; stage II: focus group; stage III: national survey. Internal consistency reliability testing and multi-trait analysis of item convergent/divergent validity were employed. Regression analysis was used to identify predictors of clinical trials nurse knowledge and skills.   The national survey was a 48-item questionnaire, measuring six clinical trial knowledge and seven skills sub-scales. Of 61 respondents, 90% were women, with mean age 43 years, 19 years as a Registered Nurse and 5 years as a cancer clinical trials nurse. Self-reported knowledge and skills were satisfactory to good. Internal consistency reliability was high (Cronbach's alpha: knowledge = 0·98; skills = 0·90). Criteria for item convergent/divergent validity were met. Number of years as cancer clinical trials nurse was positively related to self-reported knowledge and skills.   Preliminary data suggest that the national survey is reliable and valid. Data have contributed to better understanding the knowledge and skills of cancer clinical trials nurse in Australia and development of a postgraduate course in clinical trials. © 2011 Blackwell Publishing Ltd.

  17. Design and application of an EPICS compatible slow plant system controller in J-TEXT tokamak

    Energy Technology Data Exchange (ETDEWEB)

    Zhang, J.; Zhang, M. [State Key Laboratory of Advanced Electromagnetic Engineering and Technology, Huazhong University of Science and Technology, Wuhan 430074 (China); College of Electrical and Electronic Engineering, Huazhong University of Science and Technology, Wuhan 430074 (China); Zheng, W., E-mail: zhengwei@hust.edu.cn [State Key Laboratory of Advanced Electromagnetic Engineering and Technology, Huazhong University of Science and Technology, Wuhan 430074 (China); College of Electrical and Electronic Engineering, Huazhong University of Science and Technology, Wuhan 430074 (China); Zhuang, G.; Ding, T. [State Key Laboratory of Advanced Electromagnetic Engineering and Technology, Huazhong University of Science and Technology, Wuhan 430074 (China); College of Electrical and Electronic Engineering, Huazhong University of Science and Technology, Wuhan 430074 (China)

    2014-05-15

    Highlights: • Underlying functionalities are encapsulated into plug-and-play modules. • The slow controller is EPICS compatible. • The slow controller can work as PSH. - Abstract: J-TEXT tokamak has recently implemented J-TEXT COntrol, Data Access and Communication (CODAC) system on the principle of ITER CODAC. The control network in J-TEXT CODAC system is based on Experimental Physics and Industrial Control System (EPICS). However, former slow plant system controllers in J-TEXT did not support EPICS. Therefore, J-TEXT has designed an EPICS compatible slow controller. And moreover, the slow controller also acts the role of Plant System Host (PSH), which helps non-EPICS controllers to keep working in J-TEXT CODAC system. The basic functionalities dealing with user defined tasks have been modularized into driver or plug-in modules, which are plug-and-play and configured with XML files according to specific control task. In this case, developers are able to implement various kinds of control tasks with these reusable modules, regardless of how the lower-lever functions are implemented, and mainly focusing on control algorithm. And it is possible to develop custom-built modules by themselves. This paper presents design of the slow controller. Some applications of the slow controller have been deployed in J-TEXT, and will be introduced in this paper.

  18. Design and application of an EPICS compatible slow plant system controller in J-TEXT tokamak

    International Nuclear Information System (INIS)

    Zhang, J.; Zhang, M.; Zheng, W.; Zhuang, G.; Ding, T.

    2014-01-01

    Highlights: • Underlying functionalities are encapsulated into plug-and-play modules. • The slow controller is EPICS compatible. • The slow controller can work as PSH. - Abstract: J-TEXT tokamak has recently implemented J-TEXT COntrol, Data Access and Communication (CODAC) system on the principle of ITER CODAC. The control network in J-TEXT CODAC system is based on Experimental Physics and Industrial Control System (EPICS). However, former slow plant system controllers in J-TEXT did not support EPICS. Therefore, J-TEXT has designed an EPICS compatible slow controller. And moreover, the slow controller also acts the role of Plant System Host (PSH), which helps non-EPICS controllers to keep working in J-TEXT CODAC system. The basic functionalities dealing with user defined tasks have been modularized into driver or plug-in modules, which are plug-and-play and configured with XML files according to specific control task. In this case, developers are able to implement various kinds of control tasks with these reusable modules, regardless of how the lower-lever functions are implemented, and mainly focusing on control algorithm. And it is possible to develop custom-built modules by themselves. This paper presents design of the slow controller. Some applications of the slow controller have been deployed in J-TEXT, and will be introduced in this paper

  19. Clinical trials of CAR-T cells in China

    Directory of Open Access Journals (Sweden)

    Bingshan Liu

    2017-10-01

    Full Text Available Abstract Novel immunotherapeutic agents targeting tumor-site microenvironment are revolutionizing cancer therapy. Chimeric antigen receptor (CAR-engineered T cells are widely studied for cancer immunotherapy. CD19-specific CAR-T cells, tisagenlecleucel, have been recently approved for clinical application. Ongoing clinical trials are testing CAR designs directed at novel targets involved in hematological and solid malignancies. In addition to trials of single-target CAR-T cells, simultaneous and sequential CAR-T cells are being studied for clinical applications. Multi-target CAR-engineered T cells are also entering clinical trials. T cell receptor-engineered CAR-T and universal CAR-T cells represent new frontiers in CAR-T cell development. In this study, we analyzed the characteristics of CAR constructs and registered clinical trials of CAR-T cells in China and provided a quick glimpse of the landscape of CAR-T studies in China.

  20. 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 ...

  1. Investigators' viewpoint of clinical trials in India: Past, present and future

    Directory of Open Access Journals (Sweden)

    Mohandas K Mallath

    2017-01-01

    Full Text Available India's success in producing food and milk for its population (Green Revolution and White Revolution happened because of scientific research and field trials. Likewise improving the health of Indians needs clinical research and clinical trials. A Large proportion of the sick Indians are poor, illiterate with no access to good health care. They are highly vulnerable to inducement and exploitation in clinical trials. The past two decades saw the rise and fall of clinical trials in India. The rise happened when our regulators created a favorable environment, and Indian investigators were invited to participate in global clinical trials. The gap between the demand and supply resulted in inadequate protection of the trial participants. Reports of abuses of the vulnerable trial participants followed by public interest litigations led to strengthening of regulations by the regulators. The stringent new regulations made the conduct of clinical trials more laborious and increased the cost of clinical trials in India. There was a loss of interest in sponsored clinical trials resulting in the fall in global clinical trials in India. Following repeated appeals by the investigators, the Indian regulators have recently relaxed some of the stringent regulations, while continuing to ensure the adequate patient protection. Clinical trials that are relevant to our population and conducted by well-trained investigators and monitored by trained and registered Ethics Committees will increase in the future. We must remain vigilant, avoid previous mistakes, and strive hard to protect the trial participants in the future trials.

  2. Differences in Investigator-Initiated Trials between Japan and Other Countries: Analyses of Clinical Trials Sponsored by Academia and Government in the ClinicalTrials.gov Registry and in the Three Japanese Registries.

    Directory of Open Access Journals (Sweden)

    Tatsuya Ito

    Full Text Available Following the amendment of the Pharmaceutical Affairs Law in Japan in 2003 researchers were permitted to begin investigator-initiated trials (IITs. In subsequent years, however, the number of IITs remained low. In other countries in Asia as well as in Europe, North America, and South Africa, the number of IITs has increased over the past decade. The differences in the characteristics of IITs between Japan and other countries are unknown. Some studies have analyzed the characteristics of all clinical trials according to registry databases, but there has been less research focusing on IITs.The purpose of this study is to analyze the characteristics of IITs in the ClinicalTrials.gov registry and in the three Japanese registries, to identify differences in IITs between Japan and other countries.Using Thomson Reuters Pharma™, trials sponsored by academia and government as IITs in 2010 and registered in ClinicalTrials.gov were identified. IITs from 2004 to 2012 in Japan were identified in the three Japanese registries: the University Hospital Medical Information Network Clinical Trials Registry, the Japan Pharmaceutical Information Center Clinical Trials Information, and the Japan Medical Association Center for Clinical Trials, Clinical Trials Registry. Characterization was made of the trial purposes, phases, participants, masking, arms, design, controls, and other data.New and revised IITs registered in ClinicalTrials.gov during 2010 averaged about 40% of all sponsor-identified trials. IITs were nearly all early-phase studies with small numbers of participants. A total of 56 Japanese IITs were found over a period of 8 years, and these were also almost nearly all early-phase studies with small numbers of participants.There appear to be no great differences between Japan and other countries in terms of characteristics of IITs. These results should prompt a new review of the IIT environment in Japan.

  3. Evaluation of eligibility and recruitment in breast cancer clinical trials.

    Science.gov (United States)

    Lemieux, Julie; Forget, Geneviève; Brochu, Olyvia; Provencher, Louise; Cantin, Guy; Desbiens, Christine; Doyle, Catherine; Poirier, Brigitte; Camden, Stéphanie; Durocher, Martin

    2014-08-01

    Objectives of the study were to measure recruitment rates in clinical trials and to identify patients, physicians or trials characteristics associated with higher recruitment rates. Among patients who had a clinical trial available for their cancer, 83.5% (345/413) met the eligibility criteria to at least one clinical trial. At least one trial was proposed to 33.1% (113/341) of the eligible patients and 19.7% (68/345) were recruited. Overall recruitment was 16.5% (68/413). In multivariate analyses, trial proposal and enrollment were lower for elderly patients and higher in high cancer stages. Trials from pharmaceutical industry had higher recruitment rates and trials testing hormonal therapy enrolled more patients. Breast cancer patients' accrual to a clinical trial could be improved by trying to systematically identify all eligible patients and propose a trial to those eligible and to whom the treatment is planned to be equivalent to the standard arm of the trial. Copyright © 2014 Elsevier Ltd. All rights reserved.

  4. Prospective registration of clinical trials in India: strategies, achievements & challenges.

    Science.gov (United States)

    Tharyan, Prathap

    2009-02-01

    This paper traces the development of the Clinical Trial Registry-India (CTRI) against the backdrop of the inequities in healthcare and the limitations in the design, conduct, regulation, oversight and reporting of clinical trials in India. It describes the scope and goals of the CTRI, the data elements it seeks and the process of registering clinical trials. It reports progress in trial registration in India and discusses the challenges in ensuring that healthcare decisions are informed by all the evidence. A descriptive survey of developments in clinical trial registration in India from publications in the Indian medical literature supplemented by first hand knowledge of these developments and an evaluation of how well clinical trials registered in the CTRI up to 10 January, 2009 comply with the requirements of the CTRI and the World Health Organization's International Clinical Trial Registry (WHO ICTRP). Considerable inequities exist within the Indian health system. Deficiencies in healthcare provision and uneven regulation of, and access to, affordable healthcare co-exists with a large private health system of uneven quality. India is now a preferred destination for outsourced clinical trials but is plagued by poor ethical oversight of the many trial sites and scant information of their existence. The CTRI's vision of conforming to international requirements for transparency and accountability but also using trial registration as a means of improving trial design, conduct and reporting led to the selection of registry-specific dataset items in addition to those endorsed by the WHO ICTRP. Compliance with these requirements is good for the trials currently registered but these trials represent only a fraction of the trials in progress in India. Prospective trial registration is a reality in India. The challenges facing the CTRI include better engagement with key stakeholders to ensure increased prospective registration of clinical trials and utilization of

  5. Evaluating biomarkers for prognostic enrichment of clinical trials.

    Science.gov (United States)

    Kerr, Kathleen F; Roth, Jeremy; Zhu, Kehao; Thiessen-Philbrook, Heather; Meisner, Allison; Wilson, Francis Perry; Coca, Steven; Parikh, Chirag R

    2017-12-01

    A potential use of biomarkers is to assist in prognostic enrichment of clinical trials, where only patients at relatively higher risk for an outcome of interest are eligible for the trial. We investigated methods for evaluating biomarkers for prognostic enrichment. We identified five key considerations when considering a biomarker and a screening threshold for prognostic enrichment: (1) clinical trial sample size, (2) calendar time to enroll the trial, (3) total patient screening costs and the total per-patient trial costs, (4) generalizability of trial results, and (5) ethical evaluation of trial eligibility criteria. Items (1)-(3) are amenable to quantitative analysis. We developed the Biomarker Prognostic Enrichment Tool for evaluating biomarkers for prognostic enrichment at varying levels of screening stringency. We demonstrate that both modestly prognostic and strongly prognostic biomarkers can improve trial metrics using Biomarker Prognostic Enrichment Tool. Biomarker Prognostic Enrichment Tool is available as a webtool at http://prognosticenrichment.com and as a package for the R statistical computing platform. In some clinical settings, even biomarkers with modest prognostic performance can be useful for prognostic enrichment. In addition to the quantitative analysis provided by Biomarker Prognostic Enrichment Tool, investigators must consider the generalizability of trial results and evaluate the ethics of trial eligibility criteria.

  6. Using e-technologies in clinical trials.

    Science.gov (United States)

    Rosa, Carmen; Campbell, Aimee N C; Miele, Gloria M; Brunner, Meg; Winstanley, Erin L

    2015-11-01

    Clinical trials have been slow to incorporate e-technology (digital and electronic technology that utilizes mobile devices or the Internet) into the design and execution of studies. In the meantime, individuals and corporations are relying more on electronic platforms and most have incorporated such technology into their daily lives. This paper provides a general overview of the use of e-technologies in clinical trials research, specifically within the last decade, marked by rapid growth of mobile and Internet-based tools. Benefits of and challenges to the use of e-technologies in data collection, recruitment and retention, delivery of interventions, and dissemination are provided, as well as a description of the current status of regulatory oversight of e-technologies in clinical trials research. As an example of ways in which e-technologies can be used for intervention delivery, a summary of e-technologies for treatment of substance use disorders is presented. Using e-technologies to design and implement clinical trials has the potential to reach a wide audience, making trials more efficient while also reducing costs; however, researchers should be cautious when adopting these tools given the many challenges in using new technologies, as well as threats to participant privacy/confidentiality. Challenges of using e-technologies can be overcome with careful planning, useful partnerships, and forethought. The role of web- and smartphone-based applications is expanding, and the increasing use of those platforms by scientists and the public alike make them tools that cannot be ignored. Published by Elsevier Inc.

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

    Science.gov (United States)

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

    2017-08-01

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

  8. Clinical trials transparency and the Trial and Experimental Studies Transparency (TEST) act.

    Science.gov (United States)

    Logvinov, Ilana

    2014-03-01

    Clinical trial research is the cornerstone for successful advancement of medicine that provides hope for millions of people in the future. Full transparency in clinical trials may allow independent investigators to evaluate study designs, perform additional analysis of data, and potentially eliminate duplicate studies. Current regulatory system and publishers rely on investigators and pharmaceutical industries for complete and accurate reporting of results from completed clinical trials. Legislation seems to be the only way to enforce mandatory disclosure of results. The Trial and Experimental Studies Transparency (TEST) Act of 2012 was introduced to the legislators in the United States to promote greater transparency in research industry. Public safety and advancement of science are the driving forces for the proposed policy change. The TEST Act may benefit the society and researchers; however, there are major concerns with participants' privacy and intellectual property protection. Copyright © 2014 Elsevier Inc. All rights reserved.

  9. Validity of randomized clinical trials in gastroenterology from 1964-2000

    DEFF Research Database (Denmark)

    Kjaergard, Lise L; Frederiksen, Sarah L; Gluud, Christian

    2002-01-01

    The internal validity of clinical trials depends on the adequacy of the reported methodological quality. We assessed the methodological quality of all 383 randomized clinical trials published in GASTROENTEROLOGY as original articles from 1964 to 2000.......The internal validity of clinical trials depends on the adequacy of the reported methodological quality. We assessed the methodological quality of all 383 randomized clinical trials published in GASTROENTEROLOGY as original articles from 1964 to 2000....

  10. 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.

  11. Design and Implementation of a Web-based Monitoring System by using EPICS Channel Access Protocol

    International Nuclear Information System (INIS)

    An, Eun Mi; Song, Yong Gi

    2009-01-01

    Proton Engineering Frontier Project (PEFP) has developed a 20MeV proton accelerator, and established a distributed control system based on EPICS for sub-system components such as vacuum unit, beam diagnostics, and power supply system. The control system includes a real-time monitoring and alarm functions. From the aspect of a efficient maintenance of a control system and a additional extension of subsystems, EPICS software framework was adopted. In addition, a control system should be capable of providing an easy access for users and a real-time monitoring on a user screen. Therefore, we have implemented a new web-based monitoring server with several libraries. By adding DB module, the new IOC web monitoring system makes it possible to monitor the system through the web. By integrating EPICS Channel Access (CA) and Database libraries into a Database module, the web-based monitoring system makes it possible to monitor the sub-system status through user's internet browser. In this study, we developed a web based monitoring system by using EPICS IOC (Input Output Controller) with IBM server

  12. Ethical considerations in industry-sponsored multiregional clinical trials.

    Science.gov (United States)

    Ibia, Ekopimo; Binkowitz, Bruce; Saillot, Jean-Louis; Talerico, Steven; Koerner, Chin; Ferreira, Irene; Agarwal, Anupam; Metz, Craig; Maman, Marianne

    2010-01-01

    During the last several decades, the scientific and ethics communities have addressed important ethical issues in medical research, resulting in the elaboration and adoption of concepts, guidelines, and codes. Ethical issues in the conduct of Multiregional Clinical Trials have attracted significant attention mainly in the last two decades. With the globalization of clinical research and the rapid expansion to countries with a limited tradition of biomedical research, sponsors must proactively address local ethical issues, the adequacy of oversight as well as the applicability and validity of data, and scientific conclusions drawn from diverse patient populations. This paper highlights some core ethical principles and milestones in medical research, and, from an industry perspective, it discusses ethical issues that the clinical trial team may face when conducting Multiregional Clinical Trials (MRCT, clinical trials conducted at sites located across multiple geographic regions of the world). This paper further highlights the areas of consensus and controversies and proposes points to consider. Copyright © 2010 John Wiley & Sons, Ltd.

  13. Pancreatic cancer clinical trials and accrual in the United States.

    Science.gov (United States)

    Hoos, William A; James, Porsha M; Rahib, Lola; Talley, Anitra W; Fleshman, Julie M; Matrisian, Lynn M

    2013-09-20

    Pancreatic cancer clinical trials open in the United States and their accrual were examined to identify opportunities to accelerate progress in the treatment of pancreatic cancer. Pancreatic cancer-specific clinical trials open in the United States in the years 2011 and 2012 were obtained from the Pancreatic Cancer Action Network database. Accrual information was obtained from trial sponsors. The portfolio of pancreatic cancer clinical trials identified by type (adenocarcinoma or neuroendocrine), phase, disease stage, and treatment approach is reported. More than half of trials for patients with pancreatic ductal adenocarcinoma applied biologic insights to new therapeutic approaches, and 38% focused on optimization of radiation or chemotherapy delivery or regimens. In 2011, pancreatic cancer trials required total enrollment of 11,786 patients. Actual accrual to 93.2% of trials was 1,804 patients, an estimated 4.57% of the patients with pancreatic cancer alive in that year. The greatest need was for patients with resectable cancer. Trials open in 2011 enrolled an average of 15% of their total target accrual. Physician recommendations greatly influenced patients' decision to enroll or not enroll onto a clinical trial. Matching to a clinical trial within a 50-mile radius and identifying trials for recurrent/refractory disease were documented as challenges for patient accrual. Overall trial enrollment indicates that pancreatic cancer trials open in 2011 would require 6.7 years on average to complete accrual. These results suggest that harmonizing patient supply and demand for clinical trials is required to accelerate progress toward improving survival in pancreatic cancer.

  14. The standardized computerized 24-h dietary recall method EPIC-Soft adapted for pan-European dietary monitoring

    DEFF Research Database (Denmark)

    Slimani, N.; Casagrande, C.; Nicolas, G.

    2011-01-01

    monitoring. Within European Food Consumption Validation (EFCOVAL), EPIC-Soft was adapted and further developed on various aspects that were required to optimize its use. In this paper, we present the structure and main interview steps of the EPIC-Soft program, after implementation of a series of new...

  15. Quality assurance of asthma clinical trials.

    Science.gov (United States)

    Malmstrom, Kerstin; Peszek, Iza; Al Botto; Lu, Susan; Enright, Paul L; Reiss, Theodore F

    2002-04-01

    Accuracy and repeatability of spirometry measurements are essential to obtain reliable efficacy data in randomized asthma clinical trials. We report our experience with a centralized spirometry quality assurance program that we implemented in our phase III asthma trials. Six asthma trials of 4 to 21 weeks in duration were conducted at 232 clinical centers in 31 countries. Approximately 23,100 prebronchodilator and 13,700 postbronchodilator spirometry tests were collected from 2523 adult and 336 pediatric asthmatic patients. The program used a standard spirometer (the Renaissance spirometry system) with maneuver quality messages and automated quality grading of the spirometry tests. Each clinical center transmitted spirometry data weekly to a central database, where uniform monitoring of data quality was performed and feedback was provided in weekly quality reports. Seventy-nine percent of all patients performed spirometry sessions with quality that either met or exceeded American Thoracic Society standards and improved over time. Good-quality spirometry was associated with (1) less severe asthma; (2) active treatment; (3) infrequent nocturnal awakenings; (4) age above 15 years; and (5) low body weight. Maneuver-induced bronchospasm was rare. Good-quality spirometry was observed in multicenter asthma clinical trials that employed a standard spirometer and continuous monitoring. Both within- and between-patient variability decreased. Spirometry quality improved with time as study participants and technicians gained experience.

  16. Clinical trials for stem cell transplantation: when are they needed?

    Science.gov (United States)

    Van Pham, Phuc

    2016-04-27

    In recent years, both stem cell research and the clinical application of these promising cells have increased rapidly. About 1000 clinical trials using stem cells have to date been performed globally. More importantly, more than 10 stem cell-based products have been approved in some countries. With the rapid growth of stem cell applications, some countries have used clinical trials as a tool to diminish the rate of clinical stem cell applications. However, the point at which stem cell clinical trials are essential remains unclear. This commentary discusses when stem cell clinical trials are essential for stem cell transplantation therapies.

  17. Constraining the Origin of Phobos with the Elpasolite Planetary Ice and Composition Spectrometer (EPICS) - Simulated Performance

    Science.gov (United States)

    Nowicki, S. F.; Mesick, K.; Coupland, D. D. S.; Dallmann, N. A.; Feldman, W. C.; Stonehill, L. C.; Hardgrove, C.; Dibb, S.; Gabriel, T. S. J.; West, S.

    2017-12-01

    Elpasolites are a promising new family of inorganic scintillators that can detect both gamma rays and neutrons within a single detector volume, reducing the instrument size, weight, and power (SWaP), all of which are critical for planetary science missions. The ability to distinguish between neutron and gamma events is done through pulse shape discrimination (PSD). The Elpasolite Planetary Ice and Composition Spectrometer (EPICS) utilizes elpasolites in a next-generation, highly capable, low-SWaP gamma-ray and neutron spectrometer. We present simulated capabilities of EPICS sensitivities to neutron and gamma-rays, and demonstrate how EPICS can constrain the origin of Phobos between the following three main hypotheses: 1) accretion after a giant impact with Mars, 2) co-accretion with Mars, and 3) capture of an external body. The MCNP6 code was used to calculate the neutron and gamma-ray flux that escape the surface of Phobos, and GEANT4 to model the response of the EPICS instrument on orbit around Phobos.

  18. Elpasolite Planetary Ice and Composition Spectrometer (EPICS): A Low-Resource Combined Gamma-Ray and Neutron Spectrometer for Planetary Science

    Science.gov (United States)

    Stonehill, L. C.; Coupland, D. D. S.; Dallmann, N. A.; Feldman, W. C.; Mesick, K.; Nowicki, S.; Storms, S.

    2017-12-01

    The Elpasolite Planetary Ice and Composition Spectrometer (EPICS) is an innovative, low-resource gamma-ray and neutron spectrometer for planetary science missions, enabled by new scintillator and photodetector technologies. Neutrons and gamma rays are produced by cosmic ray interactions with planetary bodies and their subsequent interactions with the near-surface materials produce distinctive energy spectra. Measuring these spectra reveals details of the planetary near-surface composition that are not accessible through any other phenomenology. EPICS will be the first planetary science instrument to fully integrate the neutron and gamma-ray spectrometers. This integration is enabled by the elpasolite family of scintillators that offer gamma-ray spectroscopy energy resolutions as good as 3% FWHM at 662 keV, thermal neutron sensitivity, and the ability to distinguish gamma-ray and neutron signals via pulse shape differences. This new detection technology will significantly reduce size, weight, and power (SWaP) while providing similar neutron performance and improved gamma energy resolution compared to previous scintillator instruments, and the ability to monitor the cosmic-ray source term. EPICS will detect scintillation light with silicon photomultipliers rather than traditional photomultiplier tubes, offering dramatic additional SWaP reduction. EPICS is under development with Los Alamos National Laboratory internal research and development funding. Here we report on the EPICS design, provide an update on the current status of the EPICS development, and discuss the expected sensitivity and performance of EPICS in several potential missions to airless bodies.

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

    Directory of Open Access Journals (Sweden)

    Carolina Gomes Freitas

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

  20. Sabiduría epicúrea y Psicología

    Directory of Open Access Journals (Sweden)

    Vicente Pelechano

    2006-01-01

    Full Text Available Se presenta el marco teórico, la lógica de elaboración y primeros datos de validación de un cuestionario de sabiduría epicúrea (EPI-1 que ha sido cumplimentado por dos muestras de 473 y 266 adultos, con un predominio de mujeres. Además, se han cumplimentado el cuestionario NEO-PI-R de Costa y McCrae de los cinco grandes y dos escalas conectadas teóricamente con concepciones de sabiduría: una de prudencia y otra de intolerancia a la ambigüedad. Los resultados sugieren que, aunque sin una consistencia alta, se pueden rastrear en nuestros días los elementos básicos de la sabiduría epicúrea que se mezclan con otros de corte más funcional. Las relaciones con los cinco grandes así como con prudencia interpersonal e intolerancia de la ambigüedad demuestran que la sabiduría epicúrea no puede identificarse con ninguna de estas dimensiones, aunque guarda relaciones tenues con neuroticismo, apertura a la experiencia e intolerancia de la ambigüedad; asimismo se presenta como independiente de “prudencia” operacionalizada mediante refranes, que representa más bien estrategias de “supervivencia interpersonal”. Los resultados alcanzados se discuten dentro de un modelo de sabiduría alternativo al del grupo de Baltes en Berlín.

  1. Developments in clinical trials: a Pharma Matters report.

    Science.gov (United States)

    Arjona, A; Nuskey, B; Rabasseda, X; Arias, E

    2014-08-01

    As the pharmaceutical industry strives to meet the ever-increasing complexity of drug development, new technology in clinical trials has become a beacon of hope. With big data comes the promise of accelerated patient recruitment, real-time monitoring of clinical trials, bioinformatics empowerment of quicker phase progression, and the overwhelming benefits of precision medicine for select trials. Risk-based monitoring stands to benefit as well. With a strengthening focus on centralized data by the FDA and industry's transformative initiative, TransCelerate, a new era in trial risk mitigation has begun. The traditional method of intensive on-site monitoring is becoming a thing of the past as statistical, real-time analysis of site and trial-wide data provides the means to monitor with greater efficiency and effectiveness from afar. However, when it comes to big data, there are challenges that lie ahead. Patient privacy, commercial investment protection, technology woes and data variability are all limitations to be met with considerable thought. At the Annual Meeting of the American Academy of Dermatology this year, clinical trials on psoriasis, atopic dermatitis and other skin diseases were discussed in detail. This review of clinical research reports on novel therapies for psoriasis and atopic dermatitis reveals the impact of these diseases and the drug candidates that have been successful in phase II and III studies. Data-focused highlights of novel dermatological trials, as well as real-life big data approaches and an insight on the new methodology of risk-based monitoring, are all discussed in this edition of Developments in Clinical Trials. Copyright 2014 Prous Science, S.A.U. or its licensors. All rights reserved.

  2. Uncertainties in cloud phase and optical thickness retrievals from the Earth Polychromatic Imaging Camera (EPIC)

    Science.gov (United States)

    Meyer, Kerry; Yang, Yuekui; Platnick, Steven

    2018-01-01

    This paper presents an investigation of the expected uncertainties of a single channel cloud optical thickness (COT) retrieval technique, as well as a simple cloud temperature threshold based thermodynamic phase approach, in support of the Deep Space Climate Observatory (DSCOVR) mission. DSCOVR cloud products will be derived from Earth Polychromatic Imaging Camera (EPIC) observations in the ultraviolet and visible spectra. Since EPIC is not equipped with a spectral channel in the shortwave or mid-wave infrared that is sensitive to cloud effective radius (CER), COT will be inferred from a single visible channel with the assumption of appropriate CER values for liquid and ice phase clouds. One month of Aqua MODIS daytime granules from April 2005 is selected for investigating cloud phase sensitivity, and a subset of these granules that has similar EPIC sun-view geometry is selected for investigating COT uncertainties. EPIC COT retrievals are simulated with the same algorithm as the operational MODIS cloud products (MOD06), except using fixed phase-dependent CER values. Uncertainty estimates are derived by comparing the single channel COT retrievals with the baseline bi-spectral MODIS retrievals. Results show that a single channel COT retrieval is feasible for EPIC. For ice clouds, single channel retrieval errors are minimal (clouds the error is mostly limited to within 10%, although for thin clouds (COT cloud masking and cloud temperature retrievals are not considered in this study. PMID:29619116

  3. Update on clinical trials in Dysphagia.

    Science.gov (United States)

    Logemann, Jeri A

    2006-04-01

    Randomized clinical trials (RCTs) are often known as the gold standard in treatment efficacy studies. This article defines the characteristics of RCTs and the factors that investigators must consider in designing clinical trials in dysphagia. Design issues unique to behavioral treatments often used in dysphagia are discussed. Ongoing RCTs in dysphagia are described including studies of (1) the effectiveness of the Shaker exercise versus standardized treatment in patients with severe dysphagia resulting from stroke or treatment for head and neck cancer who have been nonoral for at least three months; (2) the comparative effects of nectar- and honey-thickened liquids versus chin tuck posture and in patients with dementia or Parkinson's disease with or without dementia who aspirate on thin liquids; and (3) the comparative effects of muscle exercise versus sensory postural therapy for dysphagia resulting from treatment for head and neck cancer. Issues in generalizing from the results of clinical trials are also described.

  4. Application study of EPICS-based redundant method for reactor control system

    International Nuclear Information System (INIS)

    Zhang Ning; Han Lifeng; Chen Yongzhong; Guo Bing; Yin Congcong

    2013-01-01

    In the reactor control system prototype development of TMSR (Thorium Molten Salt Reactor system, CAS) project, EPICS (Experimental Physics and Industrial Control System) is adopted as Instrument and Control software platform. For the aim of IOC (Input/Output Controller) redundancy and data synchronization of the system, the EPICS-based RMT (Redundancy Monitor Task ) software package and its data-synchronization component CCE (Continuous Control Executive) were introduced. By the development of related IOC driver, redundant switch-over control of server IOC was implemented. The method of redundancy implementation using RMT in server and redundancy performance test for power control system are discussed in this paper. (authors)

  5. OARSI Clinical Trials Recommendations

    DEFF Research Database (Denmark)

    McAlindon, T. E.; Driban, J. B.; Henrotin, Y.

    2015-01-01

    The goal of this document is to update the original OARSI recommendations specifically for the design, conduct, and reporting of clinical trials that target symptom or structure modification among individuals with knee osteoarthritis (OA). To develop recommendations for the design, conduct...

  6. [How to prevent hazards and to reduce risk in clinical trials?].

    Science.gov (United States)

    Czarkowski, Marek

    2008-12-01

    Different stakeholders involved in clinical trials are exposed to hazards related with this biomedical research. Beside clinical trials participants other important stakeholders are: investigators, sponsors, centers and clinical research organizations. Hazard prevention needs effective methods of hazard disclosure and analysis. A reduction of risks related with clinical trials is possible due to education, training, inspections, research discipline and penalties. Effective ways of hazard elimination or hazard reduction should be developed as well. Education and training should be offered to all stakeholders but their forms and contents should be adapted to different types of stakeholders. Direct control of the clinical trials should be held by stakeholders conducting clinical trials and outside inspections should be done by other institutions like clinical research organizations, research ethics committees and The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products. Serious oversight is an absence of any independent inspection during a phase of publication of clinical trial results. We should not accept any exception from the golden rule that results of all clinical trials must be published. Indemnity for damages is a popular way of compensation for clinical trials participants. Investigators, sponsors and centers should have valid liability insurance. Drastic measures for reduction of risks in clinical trials are different kinds of penalties. They should prevent participation of unreliable stakeholders and promote those who respect regulations and high ethical standards.

  7. Quantifying and visualizing site performance in clinical trials.

    Science.gov (United States)

    Yang, Eric; O'Donovan, Christopher; Phillips, JodiLyn; Atkinson, Leone; Ghosh, Krishnendu; Agrafiotis, Dimitris K

    2018-03-01

    One of the keys to running a successful clinical trial is the selection of high quality clinical sites, i.e., sites that are able to enroll patients quickly, engage them on an ongoing basis to prevent drop-out, and execute the trial in strict accordance to the clinical protocol. Intuitively, the historical track record of a site is one of the strongest predictors of its future performance; however, issues such as data availability and wide differences in protocol complexity can complicate interpretation. Here, we demonstrate how operational data derived from central laboratory services can provide key insights into the performance of clinical sites and help guide operational planning and site selection for new clinical trials. Our methodology uses the metadata associated with laboratory kit shipments to clinical sites (such as trial and anonymized patient identifiers, investigator names and addresses, sample collection and shipment dates, etc.) to reconstruct the complete schedule of patient visits and derive insights about the operational performance of those sites, including screening, enrollment, and drop-out rates and other quality indicators. This information can be displayed in its raw form or normalized to enable direct comparison of site performance across studies of varied design and complexity. Leveraging Covance's market leadership in central laboratory services, we have assembled a database of operational metrics that spans more than 14,000 protocols, 1400 indications, 230,000 unique investigators, and 23 million patient visits and represents a significant fraction of all clinical trials run globally in the last few years. By analyzing this historical data, we are able to assess and compare the performance of clinical investigators across a wide range of therapeutic areas and study designs. This information can be aggregated across trials and geographies to gain further insights into country and regional trends, sometimes with surprising results. The

  8. Clinical efficacy and safety evaluation of tailoring iron chelation practice in thalassaemia patients from Asia-Pacific: a subanalysis of the EPIC study of deferasirox.

    Science.gov (United States)

    Viprakasit, Vip; Ibrahim, Hishamshah; Ha, Shau-Yin; Ho, Phoebe Joy; Li, Chi-Kong; Chan, Lee-Lee; Chiu, Chang-Fang; Sutcharitchan, Pranee; Habr, Dany; Domokos, Gabor; Roubert, Bernard; Xue, Hong-Ling; Bowden, Donald K; Lin, Kai-Hsin

    2011-03-01

    Although thalassaemia is highly prevalent in the Asia-Pacific region, clinical data on efficacy and safety profiles of deferasirox in patients from this region are rather limited. Recently, data from the multicentre Evaluation of Patients' Iron Chelation with Exjade (EPIC) study in 1744 patients with different anaemias has provided an opportunity to analyse 1115 thalassaemia patients, of whom 444 patients were from five countries in the Asia-Pacific region (AP) for whom thalassaemia management and choice of iron chelators were similar. Compared to the rest of the world (ROW), baseline clinical data showed that the AP group appeared to be more loaded with iron (3745.0 vs. 2822.0 ng/ml) and had a higher proportion on deferoxamine monotherapy prior to the study (82.9 vs. 58.9%). Using a starting deferasirox dose based on transfusional iron intake and tailoring it to individual patient response, clinical efficacy based on serum ferritin reduction in AP and ROW thalassaemia patients was similar. Interestingly, the AP group developed a higher incidence of drug-related skin rash compared to ROW (18.0 vs. 7.2%), which may indicate different pharmacogenetic backgrounds in the two populations. Our analysis confirms that, with appropriate adjustment of dose, deferasirox can be clinically effective across different regions, with manageable side effects.

  9. Advancing the educational and career pathway for clinical trials nurses.

    Science.gov (United States)

    Scott, Kathleen; White, Kathryn; Roydhouse, Jessica K

    2013-04-01

    Clinical trials nurses play a pivotal role in the conduct of clinical research, but the educational and career pathway for these nurses remains unclear. This article reports findings from a survey of nurses working in cancer clinical trials research in Australia. Most participants held postgraduate qualifications (42 of 61); however, clinical trials education was primarily attained through short professional development courses. Interest in pursuing trial-specific postgraduate education was high, but barriers were identified, including cost, time, and unclear benefit for career advancement. Job titles varied substantially, which is indicative of an unclear employment pathway. These findings suggest that initiatives to improve the educational and career pathway for clinical trials nurses are needed and should include the following: formal educational preparation, greater consistency in employment status, and clearer career progression. These strategies should be underpinned by broad professional recognition of the clinical trials nurse as a specialized nursing role. Copyright 2013, SLACK Incorporated.

  10. Adaptive design methods in clinical trials – a review

    Directory of Open Access Journals (Sweden)

    Chang Mark

    2008-05-01

    Full Text Available Abstract In recent years, the use of adaptive design methods in clinical research and development based on accrued data has become very popular due to its flexibility and efficiency. Based on adaptations applied, adaptive designs can be classified into three categories: prospective, concurrent (ad hoc, and retrospective adaptive designs. An adaptive design allows modifications made to trial and/or statistical procedures of ongoing clinical trials. However, it is a concern that the actual patient population after the adaptations could deviate from the originally target patient population and consequently the overall type I error (to erroneously claim efficacy for an infective drug rate may not be controlled. In addition, major adaptations of trial and/or statistical procedures of on-going trials may result in a totally different trial that is unable to address the scientific/medical questions the trial intends to answer. In this article, several commonly considered adaptive designs in clinical trials are reviewed. Impacts of ad hoc adaptations (protocol amendments, challenges in by design (prospective adaptations, and obstacles of retrospective adaptations are described. Strategies for the use of adaptive design in clinical development of rare diseases are discussed. Some examples concerning the development of Velcade intended for multiple myeloma and non-Hodgkin's lymphoma are given. Practical issues that are commonly encountered when implementing adaptive design methods in clinical trials are also discussed.

  11. Applying Probabilistic Decision Models to Clinical Trial Design

    Science.gov (United States)

    Smith, Wade P; Phillips, Mark H

    2018-01-01

    Clinical trial design most often focuses on a single or several related outcomes with corresponding calculations of statistical power. We consider a clinical trial to be a decision problem, often with competing outcomes. Using a current controversy in the treatment of HPV-positive head and neck cancer, we apply several different probabilistic methods to help define the range of outcomes given different possible trial designs. Our model incorporates the uncertainties in the disease process and treatment response and the inhomogeneities in the patient population. Instead of expected utility, we have used a Markov model to calculate quality adjusted life expectancy as a maximization objective. Monte Carlo simulations over realistic ranges of parameters are used to explore different trial scenarios given the possible ranges of parameters. This modeling approach can be used to better inform the initial trial design so that it will more likely achieve clinical relevance.

  12. Motor outcome measures in Huntington disease clinical trials.

    Science.gov (United States)

    Reilmann, Ralf; Schubert, Robin

    2017-01-01

    Deficits in motor function are a hallmark of Huntington disease (HD). The Unified Huntington's Disease Rating Scale Total Motor Score (UHDRS-TMS) is a categoric clinical rating scale assessing multiple domains of motor disability in HD. The UHDRS-TMS or subsets of its items have served as primary or secondary endpoints in numerous clinical trials. In spite of a well-established video-based annual online certification system, intra- and interrater variability, subjective error, and rater-induced placebo effects remain a concern. In addition, the UHDRS-TMS was designed to primarily assess motor symptoms in manifest HD. Recently, advancement of technology resulted in the introduction of the objective Q-Motor (i.e., Quantitative-Motor) assessments in biomarker studies and clinical trials in HD. Q-Motor measures detected motor signs in blinded cross-sectional and longitudinal analyses of manifest, prodromal, and premanifest HD cohorts up to two decades before clinical diagnosis. In a multicenter clinical trial in HD, Q-Motor measures were more sensitive than the UHDRS-TMS and exhibited no placebo effects. Thus, Q-Motor measures are currently explored in several multicenter trials targeting both symptomatic and disease-modifying mechanisms. They may supplement the UHDRS-TMS, increase the sensitivity and reliability in proof-of-concept studies, and open the door for phenotype assessments in clinical trials in prodromal and premanifest HD. Copyright © 2017 Elsevier B.V. All rights reserved.

  13. Biomarkers in T cell therapy clinical trials

    Directory of Open Access Journals (Sweden)

    Kalos Michael

    2011-08-01

    Full Text Available Abstract T cell therapy represents an emerging and promising modality for the treatment of both infectious disease and cancer. Data from recent clinical trials have highlighted the potential for this therapeutic modality to effect potent anti-tumor activity. Biomarkers, operationally defined as biological parameters measured from patients that provide information about treatment impact, play a central role in the development of novel therapeutic agents. In the absence of information about primary clinical endpoints, biomarkers can provide critical insights that allow investigators to guide the clinical development of the candidate product. In the context of cell therapy trials, the definition of biomarkers can be extended to include a description of parameters of the cell product that are important for product bioactivity. This review will focus on biomarker studies as they relate to T cell therapy trials, and more specifically: i. An overview and description of categories and classes of biomarkers that are specifically relevant to T cell therapy trials, and ii. Insights into future directions and challenges for the appropriate development of biomarkers to evaluate both product bioactivity and treatment efficacy of T cell therapy trials.

  14. OARSI Clinical Trials Recommendations

    DEFF Research Database (Denmark)

    Kraus, V B; Blanco, F J; Englund, M

    2015-01-01

    The objective of this work was to describe requirements for inclusion of soluble biomarkers in osteoarthritis (OA) clinical trials and progress toward OA-related biomarker qualification. The Guidelines for Biomarkers Working Group, representing experts in the field of OA biomarker research from...

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

    Science.gov (United States)

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

    2011-06-16

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

  16. Re-Engineering Alzheimer Clinical Trials: Global Alzheimer's Platform Network.

    Science.gov (United States)

    Cummings, J; Aisen, P; Barton, R; Bork, J; Doody, R; Dwyer, J; Egan, J C; Feldman, H; Lappin, D; Truyen, L; Salloway, S; Sperling, R; Vradenburg, G

    2016-06-01

    Alzheimer's disease (AD) drug development is costly, time-consuming, and inefficient. Trial site functions, trial design, and patient recruitment for trials all require improvement. The Global Alzheimer Platform (GAP) was initiated in response to these challenges. Four GAP work streams evolved in the US to address different trial challenges: 1) registry-to-cohort web-based recruitment; 2) clinical trial site activation and site network construction (GAP-NET); 3) adaptive proof-of-concept clinical trial design; and 4) finance and fund raising. GAP-NET proposes to establish a standardized network of continuously funded trial sites that are highly qualified to perform trials (with established clinical, biomarker, imaging capability; certified raters; sophisticated management system. GAP-NET will conduct trials for academic and biopharma industry partners using standardized instrument versions and administration. Collaboration with the Innovative Medicines Initiative (IMI) European Prevention of Alzheimer's Disease (EPAD) program, the Canadian Consortium on Neurodegeneration in Aging (CCNA) and other similar international initiatives will allow conduct of global trials. GAP-NET aims to increase trial efficiency and quality, decrease trial redundancy, accelerate cohort development and trial recruitment, and decrease trial costs. The value proposition for sites includes stable funding and uniform training and trial execution; the value to trial sponsors is decreased trial costs, reduced time to execute trials, and enhanced data quality. The value for patients and society is the more rapid availability of new treatments for AD.

  17. [Clinical trial data management and quality metrics system].

    Science.gov (United States)

    Chen, Zhao-hua; Huang, Qin; Deng, Ya-zhong; Zhang, Yue; Xu, Yu; Yu, Hao; Liu, Zong-fan

    2015-11-01

    Data quality management system is essential to ensure accurate, complete, consistent, and reliable data collection in clinical research. This paper is devoted to various choices of data quality metrics. They are categorized by study status, e.g. study start up, conduct, and close-out. In each category, metrics for different purposes are listed according to ALCOA+ principles such us completeness, accuracy, timeliness, traceability, etc. Some general quality metrics frequently used are also introduced. This paper contains detail information as much as possible to each metric by providing definition, purpose, evaluation, referenced benchmark, and recommended targets in favor of real practice. It is important that sponsors and data management service providers establish a robust integrated clinical trial data quality management system to ensure sustainable high quality of clinical trial deliverables. It will also support enterprise level of data evaluation and bench marking the quality of data across projects, sponsors, data management service providers by using objective metrics from the real clinical trials. We hope this will be a significant input to accelerate the improvement of clinical trial data quality in the industry.

  18. Use of outcome measures in pulmonary hypertension clinical trials.

    Science.gov (United States)

    Parikh, Kishan S; Rajagopal, Sudarshan; Arges, Kristine; Ahmad, Tariq; Sivak, Joseph; Kaul, Prashant; Shah, Svati H; Tapson, Victor; Velazquez, Eric J; Douglas, Pamela S; Samad, Zainab

    2015-09-01

    To evaluate the use of surrogate measures in pulmonary hypertension (PH) clinical trials and how it relates to clinical practice. Studies of pulmonary arterial hypertension (PAH) employ a variety of surrogate measures in addition to clinical events because of a small patient population, participant burden, and costs. The use of these measures in PH drug trials is poorly defined. We searched PubMed/MEDLINE/Embase for randomized or prospective cohort PAH clinical treatment trials from 1985 to 2013. Extracted data included intervention, trial duration, study design, patient characteristics, and primary and secondary outcome measures. To compare with clinical practice, we assessed the use of surrogate measures in a clinical sample of patients on PH medications at Duke University Medical Center between 2003 and 2014. Between 1985 and 2013, 126 PAH trials were identified and analyzed. Surrogate measures served as primary endpoints in 119 trials (94.0%). Inclusion of invasive hemodynamics decreased over time (78.6%, 75.0%, 52.2%; P for trend = .02), while functional testing (7.1%, 60.0%, 81.5%; P for trend clinical assessments regularly incorporated serial echocardiography and 6-minute walk distance tests (92% and 95% of patients, respectively) and repeat measurement of invasive hemodynamics (46% of patients). The majority of PAH trials have utilized surrogate measures as primary endpoints. The use of these surrogate endpoints has evolved significantly over time with increasing use of patient-centered endpoints and decreasing or stable use of imaging and invasive measures. In contrast, imaging and invasive measures are commonly used in contemporary clinical practice. Further research is needed to validate and standardize currently used measures. Copyright © 2015 Elsevier Inc. All rights reserved.

  19. Industry funded clinical trials: bias and quality.

    Science.gov (United States)

    Del Parigi, Angelo

    2012-01-01

    The quality of the clinical data supporting the development and ultimately the approval for medical use of new drugs is often challenged. Many share the perception that the business goals of the pharmaceutical industry overrule the best scientific efforts to accrue critical knowledge on a new molecule, in order to inform investment of resources, regulatory approvals and appropriate use by patients. Despite this common belief, few scientists have attempted to assess objectively the quality of industry funded (IF) clinical trials by measuring it and comparing it with non-industry funded (NIF) clinical trials in a data-driven fashion. Overall, the average quality of IF clinical research has been reported to be higher than the quality of NIF clinical research.

  20. Gateways to clinical trials.

    Science.gov (United States)

    Bayés, M; Rabasseda, X; Prous, J R

    2007-12-01

    Gateways to Clinical Trials are a guide to the most recent clinical trials in current literature and congresses. The data in the following tables has been retrieved from the Clinical Trials Knowledge Area of Prous Science Intergrity, the drug discovery and development portal, http://integrity.prous.com. This issue focuses on the following selection of drugs: 249553, 2-Methoxyestradiol; Abatacept, Adalimumab, Adefovir dipivoxil, Agalsidase beta, Albinterferon alfa-2b, Aliskiren fumarate, Alovudine, Amdoxovir, Amlodipine besylate/atorvastatin calcium, Amrubicin hydrochloride, Anakinra, AQ-13, Aripiprazole, AS-1404, Asoprisnil, Atacicept, Atrasentan; Belimumab, Bevacizumab, Bortezomib, Bosentan, Botulinum toxin type B, Brivaracetam; Catumaxomab, Cediranib, Cetuximab, cG250, Ciclesonide, Cinacalcet hydrochloride, Curcumin, Cypher; Darbepoetin alfa, Denosumab, Dihydrexidine; Eicosapentaenoic acid/docosahexaenoic acid, Entecavir, Erlotinib hydrochloride, Escitalopram oxalate, Etoricoxib, Everolimus, Ezetimibe; Febuxostat, Fenspiride hydrochloride, Fondaparinux sodium; Gefitinib, Ghrelin (human), GSK-1562902A; HSV-tk/GCV; Iclaprim, Imatinib mesylate, Imexon, Indacaterol, Insulinotropin, ISIS-112989; L-Alanosine, Lapatinib ditosylate, Laropiprant; Methoxy polyethylene glycol-epoetin-beta, Mipomersen sodium, Motexafin gadolinium; Natalizumab, Nimotuzumab; OSC, Ozarelix; PACAP-38, Paclitaxel nanoparticles, Parathyroid Hormone-Related Protein-(1-36), Pasireotide, Pegfilgrastim, Peginterferon alfa-2a, Peginterferon alfa-2b, Pemetrexed disodium, Pertuzumab, Picoplatin, Pimecrolimus, Pitavastatin calcium, Plitidepsin; Ranelic acid distrontium salt, Ranolazine, Recombinant human relaxin H2, Regadenoson, RFB4(dsFv)-PE38, RO-3300074, Rosuvastatin calcium; SIR-Spheres, Solifenacin succinate, Sorafenib, Sunitinib malate; Tadalafil, Talabostat, Taribavirin hydrochloride, Taxus, Temsirolimus, Teriparatide, Tiotropium bromide, Tipifarnib, Tirapazamine, Tocilizumab; UCN-01, Ularitide

  1. Pediatric Obstructive Uropathy: Clinical Trials

    International Nuclear Information System (INIS)

    Chan, C. M. C.; Scheinman, J. I.; Roth, K. S.

    2005-01-01

    As the powerful tools of molecular biology continue to delineate new concepts of pathogenesis of diseases, new molecular-level therapeutic modalities are certain to emerge. In order to design and execute clinical trials to evaluate outcomes of these new treatment modalities, we will soon need a new supply of investigators with training and experience in clinical research. The slowly-progressive nature of chronic pediatric kidney disease often results in diagnosis being made at a time remote from initial result, and the inherently slow rate of progression makes changes difficult to measure. Thus, development of molecular markers for both diagnosis and rate of progression will be critical to studies of new therapeutic modalities. We will review general aspects of clinical trials and will use current and past studies as examples to illustrate specific points, especially as these apply to chronic kidney disease associated with obstructive uropathy in children. (author)

  2. Macronutrient, vitamin, and mineral intakes in the EPIC-Germany cohorts.

    Science.gov (United States)

    Schulze, M B; Linseisen, J; Kroke, A; Boeing, H

    2001-01-01

    This article presents intakes of nutrients in the EPIC-Heidelberg and the EPIC-Potsdam (European Investigation into Cancer and Nutrition) studies. Estimates are based on standardized 24-hour dietary recalls. Recalls from 1,013 men and 1,078 women in Heidelberg and from 1,032 men and 898 women in Potsdam were included in the analysis. The estimated nutrient intake was based on the German Food Code and Nutrient Data Base version II.3. Analyses were carried out stratified by sex and weighted for the day of the week and age. Men in Potsdam reported significantly higher intakes of energy (mean Potsdam = 10,718 kJ, mean Heidelberg = 10,387 kJ) and higher intakes of vitamins and minerals as compared with men in Heidelberg. However, Heidelberg men consumed more alcohol, alpha-tocopherol, phosphorus, calcium, and magnesium. Potsdam women reported lower energy (mean Potsdam = 7,537 kJ, mean Heidelberg = 7,855 kJ), alcohol, and cholesterol intakes as compared with Heidelberg women. Vitamin and mineral intakes were lower too, except for retinol and ascorbic acid. The intakes of energy and most nutrients observed in the Potsdam and Heidelberg study populations were within the range reported from other German studies. The observed differences between both study populations indicate different dietary patterns, increasing the exposure variation in the EPIC study. Copyright 2001 S. Karger AG, Basel

  3. Monitoring additive manufacturing based products in clinical trials

    NARCIS (Netherlands)

    Marinakis, Yorgos; Harms, Rainer; Walsh, Steven Thomas

    2017-01-01

    Under U.S. federal regulation 31 CFR §312, medical interventions must report on a series of clinical trials phases before being submitted for approval for release to the U.S. market. Clinical trials are now being performed on medical interventions that were constructed through additive

  4. Gatekeepers for pragmatic clinical trials.

    Science.gov (United States)

    Whicher, Danielle M; Miller, Jennifer E; Dunham, Kelly M; Joffe, Steven

    2015-10-01

    To successfully implement a pragmatic clinical trial, investigators need access to numerous resources, including financial support, institutional infrastructure (e.g. clinics, facilities, staff), eligible patients, and patient data. Gatekeepers are people or entities who have the ability to allow or deny access to the resources required to support the conduct of clinical research. Based on this definition, gatekeepers relevant to the US clinical research enterprise include research sponsors, regulatory agencies, payers, health system and other organizational leadership, research team leadership, human research protections programs, advocacy and community groups, and clinicians. This article provides a framework to help guide gatekeepers' decision-making related to the use of resources for pragmatic clinical trials. Relevant ethical considerations for gatekeepers include (1) concern for the interests of individuals, groups, and communities affected by the gatekeepers' decisions, including protection from harm and maximization of benefits; (2) advancement of organizational mission and values; and (3) stewardship of financial, human, and other organizational resources. Separate from these ethical considerations, gatekeepers' actions will be guided by relevant federal, state, and local regulations. This framework also suggests that to further enhance the legitimacy of their decision-making, gatekeepers should adopt transparent processes that engage relevant stakeholders when feasible and appropriate. We apply this framework to the set of gatekeepers responsible for making decisions about resources necessary for pragmatic clinical trials in the United States, describing the relevance of the criteria in different situations and pointing out where conflicts among the criteria and relevant regulations may affect decision-making. Recognition of the complex set of considerations that should inform decision-making will guide gatekeepers in making justifiable choices regarding

  5. Clinical trials integrity: a CRO perspective.

    Science.gov (United States)

    Beach, J E

    2001-01-01

    When contract research organizations (CROs) were first formed, pharmaceutical companies outsourced to them only certain aspects of the conduct of their clinical trials. At first CROs were highly specialized entities, providing, for example, either biostatistical advice, clinical research associates who monitored investigational sites for regulatory compliance, or regulatory support. Gradually, full service CROs emerged, offering a full range of services for clinical trials, including the selection of investigators and investigational sites, assistance with patient recruitment, safety surveillance and reporting, site audits, and data management and biostatistics. This evolving relationship between CROs and the pharmaceutical and medical device industries has resulted in CROs assuming more and more of the regulatory and ethical risks and responsibilities inherent in the conduct of clinical trials. In this full service role, CROs, unlike sponsors, are not interested in the outcome of study, but like sponsors, are subject to heavy regulation by the federal government, must follow applicable state laws, must respect international guidelines, and are obliged to follow their own operating procedures. Moreover, they are judged by the industry on the basis of the scope and quality of services provided, including the degree of adherence to the research protocol, regulatory requirements, and timelines; the quality of the professional working relationships with investigators and institutions, both academic and community-based; and the validity of the data. Further, CROs are subject to comprehensive audits by sponsoring companies, FDA, and other regulatory authorities. For all these reasons, CROs are being tasked with strict vigilance of all stages of the clinical trial process to ensure that the laws, regulations, and industry standards designed for the protection of human subjects and data integrity are maintained.

  6. Need for Outcome Scenario Analysis of Clinical Trials in Diabetes.

    Science.gov (United States)

    Garcia-Verdugo, Rosa; Erbach, Michael; Schnell, Oliver

    2017-03-01

    Since the FDA requirement for cardiovascular safety of all new antihyperglycemic drugs to enter the market, the number and extent of phase 3 clinical trials has markedly increased. Unexpected trial results imply an enormous economic, personal and time cost and has deleterious effects over R&D. To prevent unforeseen developments in clinical trials, we recommend performing a comprehensive prospective outcome scenario analysis before launching the trial. In this commentary, we discuss the most important factors to take in consideration for prediction of clinical trial outcome scenarios and propose a theoretical model for decision making.

  7. Cross-system evaluation of clinical trial search engines.

    Science.gov (United States)

    Jiang, Silis Y; Weng, Chunhua

    2014-01-01

    Clinical trials are fundamental to the advancement of medicine but constantly face recruitment difficulties. Various clinical trial search engines have been designed to help health consumers identify trials for which they may be eligible. Unfortunately, knowledge of the usefulness and usability of their designs remains scarce. In this study, we used mixed methods, including time-motion analysis, think-aloud protocol, and survey, to evaluate five popular clinical trial search engines with 11 users. Differences in user preferences and time spent on each system were observed and correlated with user characteristics. In general, searching for applicable trials using these systems is a cognitively demanding task. Our results show that user perceptions of these systems are multifactorial. The survey indicated eTACTS being the generally preferred system, but this finding did not persist among all mixed methods. This study confirms the value of mixed-methods for a comprehensive system evaluation. Future system designers must be aware that different users groups expect different functionalities.

  8. Money and morals: ending clinical trials for financial reasons.

    Science.gov (United States)

    Eaton, Margaret L; Kwon, Brian K; Scott, Christopher Thomas

    2015-01-01

    Too often, biopharmaceutical companies stop their clinical trials solely for financial reasons. In this chapter, we discuss this phenomenon against the backdrop of a 2011 decision by Geron Corporation to abandon its stem cell clinical trial for spinal cord injury (SCI), the preliminary results of which were released in May 2014. We argue that the resultant harms are widespread and are different in nature from the consequences of stopping trials for scientific or medical reasons. We examine the ethical and social effects that arise from such decisions and discuss them in light of ethical frameworks, including duties of individual stakeholders and corporate sponsors. We offer ways that sponsors and clinical sites can ensure that trials are responsibly started, and once started adequately protect the interests of participants. We conclude with recommendations that industry sponsors of clinical trials should adopt in order to advance a collective and patient-centered research ethic.

  9. Differential Globalization of Industry- and Non-Industry-Sponsored Clinical Trials.

    Science.gov (United States)

    Atal, Ignacio; Trinquart, Ludovic; Porcher, Raphaël; Ravaud, Philippe

    2015-01-01

    Mapping the international landscape of clinical trials may inform global health research governance, but no large-scale data are available. Industry or non-industry sponsorship may have a major influence in this mapping. We aimed to map the global landscape of industry- and non-industry-sponsored clinical trials and its evolution over time. We analyzed clinical trials initiated between 2006 and 2013 and registered in the WHO International Clinical Trials Registry Platform (ICTRP). We mapped single-country and international trials by World Bank's income groups and by sponsorship (industry- vs. non- industry), including its evolution over time from 2006 to 2012. We identified clusters of countries that collaborated significantly more than expected in industry- and non-industry-sponsored international trials. 119,679 clinical trials conducted in 177 countries were analysed. The median number of trials per million inhabitants in high-income countries was 100 times that in low-income countries (116.0 vs. 1.1). Industry sponsors were involved in three times more trials per million inhabitants than non-industry sponsors in high-income countries (75.0 vs. 24.5) and in ten times fewer trials in low- income countries (0.08 vs. 1.08). Among industry- and non-industry-sponsored trials, 30.3% and 3.2% were international, respectively. In the industry-sponsored network of collaboration, Eastern European and South American countries collaborated more than expected; in the non-industry-sponsored network, collaboration among Scandinavian countries was overrepresented. Industry-sponsored international trials became more inter-continental with time between 2006 and 2012 (from 54.8% to 67.3%) as compared with non-industry-sponsored trials (from 42.4% to 37.2%). Based on trials registered in the WHO ICTRP we documented a substantial gap between the globalization of industry- and non-industry-sponsored clinical research. Only 3% of academic trials but 30% of industry trials are

  10. Differential Globalization of Industry- and Non-Industry–Sponsored Clinical Trials

    Science.gov (United States)

    Atal, Ignacio; Trinquart, Ludovic; Porcher, Raphaël; Ravaud, Philippe

    2015-01-01

    Background Mapping the international landscape of clinical trials may inform global health research governance, but no large-scale data are available. Industry or non-industry sponsorship may have a major influence in this mapping. We aimed to map the global landscape of industry- and non-industry–sponsored clinical trials and its evolution over time. Methods We analyzed clinical trials initiated between 2006 and 2013 and registered in the WHO International Clinical Trials Registry Platform (ICTRP). We mapped single-country and international trials by World Bank's income groups and by sponsorship (industry- vs. non- industry), including its evolution over time from 2006 to 2012. We identified clusters of countries that collaborated significantly more than expected in industry- and non-industry–sponsored international trials. Results 119,679 clinical trials conducted in 177 countries were analysed. The median number of trials per million inhabitants in high-income countries was 100 times that in low-income countries (116.0 vs. 1.1). Industry sponsors were involved in three times more trials per million inhabitants than non-industry sponsors in high-income countries (75.0 vs. 24.5) and in ten times fewer trials in low- income countries (0.08 vs. 1.08). Among industry- and non-industry–sponsored trials, 30.3% and 3.2% were international, respectively. In the industry-sponsored network of collaboration, Eastern European and South American countries collaborated more than expected; in the non-industry–sponsored network, collaboration among Scandinavian countries was overrepresented. Industry-sponsored international trials became more inter-continental with time between 2006 and 2012 (from 54.8% to 67.3%) as compared with non-industry–sponsored trials (from 42.4% to 37.2%). Conclusions Based on trials registered in the WHO ICTRP we documented a substantial gap between the globalization of industry- and non-industry–sponsored clinical research. Only 3% of

  11. A web-based clinical trial management system for a sham-controlled multicenter clinical trial in depression.

    Science.gov (United States)

    Durkalski, Valerie; Wenle Zhao; Dillon, Catherine; Kim, Jaemyung

    2010-04-01

    Clinical trial investigators and sponsors invest vast amounts of resources and energy into conducting trials and often face daily challenges with data management, project management, and data quality control. Rather than waiting months for study progress reports, investigators need the ability to use real-time data for the coordination and management of study activities across all study team members including site investigators, oversight committees, data and safety monitoring boards, and medical safety monitors. Web-based data management systems are beginning to meet this need but what distinguishes one system from the other are user needs/requirements and cost. To illustrate the development and implementation of a web-based data and project management system for a multicenter clinical trial designed to test the superiority of repeated transcranial magnetic stimulation versus sham for the treatment of patients with major depression. The authors discuss the reasons for not using a commercially available system for this study and describe the approach to developing their own web-based system for the OPT-TMS study. Timelines, effort, system architecture, and lessons learned are shared with the hope that this information will direct clinical trial researchers and software developers towards more efficient, user-friendly systems. The developers use a combination of generic and custom application code to allow for the flexibility to adapt the system to the needs of the study. Features of the system include: central participant registration and randomization; secure data entry at the site; participant progress/study calendar; safety data reporting; device accounting; monitor verification; and user-configurable generic reports and built-in customized reports. Hard coding was more time-efficient to address project-specific issues compared with the effort of creating a generic code application. As a consequence of this strategy, the required maintenance of the system is

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

    Directory of Open Access Journals (Sweden)

    Charlesworth Lisa

    2011-06-01

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

  13. 'Trial Exegesis': Methods for Synthesizing Clinical and Patient Reported Outcome (PRO Data in Trials to Inform Clinical Practice. A Systematic Review.

    Directory of Open Access Journals (Sweden)

    Angus G K McNair

    Full Text Available The CONSORT extension for patient reported outcomes (PROs aims to improve reporting, but guidance on the optimal integration with clinical data is lacking. This study examines in detail the reporting of PROs and clinical data from randomized controlled trials (RCTs in gastro-intestinal cancer to inform design and reporting of combined PRO and clinical data from trials to improve the 'take home' message for clinicians to use in practice.The case study was undertaken in gastro-intestinal cancer trials. Well-conducted RCTs reporting PROs with validated instruments were identified and categorized into those combining PRO and clinical data in a single paper, or those separating data into linked primary and supplemental papers. Qualitative methods were developed to examine reporting of the critical interpretation of the trial results (trial exegesis in the papers in relation of the PRO and clinical outcomes and applied to each publication category. Results were used to inform recommendations for practice.From 1917 screened abstracts, 49 high quality RCTs were identified reported in 36 combined and 15 linked primary and supplemental papers. In-depth analysis of manuscript text identified three categories for understanding trial exegesis: where authors reported a "detailed", "general", or absent PRO rationale and integrated interpretation of clinical and PRO results. A total of 11 (30% and 6 (16% combined papers reported "detailed" PRO rationale and integrated interpretation of results although only 2 (14% and 1 (7% primary papers achieved the same standard respectively. Supplemental papers provide better information with 11 (73% and 3 (20% achieving "detailed" rationale and integrated interpretation of results. Supplemental papers, however, were published a median of 20 months after the primary RCT data in lower impact factor journals (median 16.8 versus 5.2.It is recommended that single papers, with detailed PRO rationale and integrated PRO and

  14. Factors influencing participation of psychiatry inpatients in clinical trials.

    Science.gov (United States)

    Mopuru, Nandeeshwar Reddy; Jose, Sam Padamadan; Viswanath, Biju; Kumar, C Naveen; Math, Suresh Bada; Thirthalli, Jagadisha

    2018-02-01

    Serious concerns have arisen in recent years regarding the unethical and illegal practices resorted to during clinical trials. Clinical trials in psychiatry are further complicated by issues such as 'validity of consent' and 'decision making capacity' of patients. This study was planned to explore the factors determining patient participation in clinical trials. A random sample of 123 consenting psychiatry inpatients were provided the information and consent-form of a hypothetical clinical drug trial. They were interviewed regarding their decision, the decision maker and factors that led to the decision. Family members tended to be the decision makers when patients were females, had low-income, were from rural background or had severe illnesses. Anticipated side effects and not wanting to interfere with existing treatment were the common reasons for refusal to participate while hope of betterment of the patient and benefit to humanity were cited for consent. The educated, urban, affluent class had more awareness regarding unethical trials and tended to be mistrustful of the medical community leading to higher rates of non-participation. Those who were adherent with ongoing treatment were also unwilling to participate. The lesser educated, low-income patients and rural domicile patients on the other hand had lesser awareness regarding clinical trials, trusted doctors and were more likely to participate. A good doctor-patient relationship, detailed explanations and clarification regarding the study and its conduct, and building awareness regarding clinical trials among vulnerable groups is necessary to ensure a valid consent involving no coercion, removal of prejudices, and ethical conduct of trials. Copyright © 2017 Elsevier B.V. All rights reserved.

  15. NEW EPICS/RTEMS IOC BASED ON ALTERA SOC AT JEFFERSON LAB

    Energy Technology Data Exchange (ETDEWEB)

    Yan, Jianxun [Thomas Jefferson National Accelerator Facility (TJNAF), Newport News, VA (United States); Seaton, Chad [Thomas Jefferson National Accelerator Facility (TJNAF), Newport News, VA (United States); Allison, Trent L. [Thomas Jefferson National Accelerator Facility (TJNAF), Newport News, VA (United States); Bevins, Brian S. [Thomas Jefferson National Accelerator Facility (TJNAF), Newport News, VA (United States); Cuffe, Anthony W. [Thomas Jefferson National Accelerator Facility (TJNAF), Newport News, VA (United States)

    2018-02-01

    A new EPICS/RTEMS IOC based on the Altera System-on-Chip (SoC) FPGA is being designed at Jefferson Lab. The Altera SoC FPGA integrates a dual ARM Cortex-A9 Hard Processor System (HPS) consisting of processor, peripherals and memory interfaces tied seamlessly with the FPGA fabric using a high-bandwidth interconnect backbone. The embedded Altera SoC IOC has features of remote network boot via U-Boot from SD card or QSPI Flash, 1Gig Ethernet, 1GB DDR3 SDRAM on HPS, UART serial ports, and ISA bus interface. RTEMS for the ARM processor BSP were built with CEXP shell, which will dynamically load the EPICS applications at runtime. U-Boot is the primary bootloader to remotely load the kernel image into local memory from a DHCP/TFTP server over Ethernet, and automatically run RTEMS and EPICS. The first design of the SoC IOC will be compatible with Jefferson Lab’s current PC104 IOCs, which have been running in CEBAF 10 years. The next design would be mounting in a chassis and connected to a daughter card via standard HSMC connectors. This standard SoC IOC will become the next generation of low-level IOC for the accelerator controls at Jefferson Lab.

  16. Anthropometry and the Risk of Lung Cancer in EPIC

    NARCIS (Netherlands)

    Dewi, Nikmah Utami; Boshuizen, Hendriek C; Johansson, Mattias; Vineis, Paolo; Kampman, Ellen; Steffen, Annika; Tjønneland, Anne; Halkjær, Jytte; Overvad, Kim; Severi, Gianluca; Fagherazzi, Guy; Boutron-Ruault, Marie-Christine; Kaaks, Rudolf; Li, Kuanrong; Boeing, Heiner; Trichopoulou, Antonia; Bamia, Christina; Klinaki, Eleni; Tumino, Rosario; Palli, Domenico; Mattiello, Amalia; Tagliabue, Giovanna; Peeters, Petra H; Vermeulen, Roel; Weiderpass, Elisabete; Torhild Gram, Inger; Huerta, José María; Agudo, Antonio; Sánchez, María-José; Ardanaz, Eva; Dorronsoro, Miren; Quirós, José Ramón; Sonestedt, Emily; Johansson, Mikael; Grankvist, Kjell; Key, Tim; Khaw, Kay-Tee; Wareham, Nick; Cross, Amanda J; Norat, Teresa; Riboli, Elio; Fanidi, Anouar; Muller, David; Bueno-de-Mesquita, H Bas

    2016-01-01

    The associations of body mass index (BMI) and other anthropometric measurements with lung cancer were examined in 348,108 participants in the European Investigation Into Cancer and Nutrition (EPIC) between 1992 and 2010. The study population included 2,400 case patients with incident lung cancer,

  17. Anthropometry and the risk of lung cancer in EPIC

    NARCIS (Netherlands)

    Dewi, Nikmah Utami; Boshuizen, Hendriek C.; Johansson, Mattias; Vineis, Paolo; Kampman, Ellen; Steffen, Annika; Tjønneland, Anne; Halkjær, Jytte; Overvad, Kim; Severi, Gianluca; Fagherazzi, Guy; Boutron-Ruault, Marie Christine; Kaaks, Rudolf; Li, Kuanrong; Boeing, Heiner; Trichopoulou, Antonia; Bamia, Christina; Klinaki, Eleni; Tumino, Rosario; Palli, Domenico; Mattiello, Amalia; Tagliabue, Giovanna; Peeters, Petra H.; Vermeulen, Roel; Weiderpass, Elisabete; Gram, Inger Torhild; Huerta, José María; Agudo, Antonio; Sánchez, María José; Ardanaz, Eva; Dorronsoro, Miren; Quirós, José Ramón; Sonestedt, Emily; Johansson, Mikael; Grankvist, Kjell; Key, Tim; Khaw, Kay Tee; Wareham, Nick; Cross, Amanda J.; Norat, Teresa; Riboli, Elio; Fanidi, Anouar; Muller, David; Bueno-De-Mesquita, H. Bas

    2016-01-01

    The associations of body mass index (BMI) and other anthropometric measurements with lung cancer were examined in 348,108 participants in the European Investigation Into Cancer and Nutrition (EPIC) between 1992 and 2010. The study population included 2,400 case patients with incident lung cancer,

  18. Implementation of the Integrated Alarm System for KOMAC facility using EPICS framework and Eclipse

    International Nuclear Information System (INIS)

    Song, Young-Gi; Kim, Jae-Ha; Kim, Han-Sung; Kwon, Hyeok-Jung; Cho, Yong-Sub

    2017-01-01

    The alarm detecting layer is the component that monitors alarm signals which are transported to the processing part through message queue. The main purpose of the processing part is to transfer the alarm signals connecting an alarm identification and state of the alarm to database system. The operation interface of system level signal links has been developed by EPICS framework. EPICS tools have been used for monitoring device alarm status. The KOMAC alarm system was developed for offering a user-friendly, intuitive user interface. The alarm system is implemented with EPICS IOC for alarm server, eclipse-mars integrated development tool for alarm viewer, and mariadb for alarm log. The new alarm system supports intuitive user interface on alarm information and alarm history. Alarm view has plans to add login function, user permission on alarm acknowledge, user permission of PV import, search and report function.

  19. Sample size determination in clinical trials with multiple endpoints

    CERN Document Server

    Sozu, Takashi; Hamasaki, Toshimitsu; Evans, Scott R

    2015-01-01

    This book integrates recent methodological developments for calculating the sample size and power in trials with more than one endpoint considered as multiple primary or co-primary, offering an important reference work for statisticians working in this area. The determination of sample size and the evaluation of power are fundamental and critical elements in the design of clinical trials. If the sample size is too small, important effects may go unnoticed; if the sample size is too large, it represents a waste of resources and unethically puts more participants at risk than necessary. Recently many clinical trials have been designed with more than one endpoint considered as multiple primary or co-primary, creating a need for new approaches to the design and analysis of these clinical trials. The book focuses on the evaluation of power and sample size determination when comparing the effects of two interventions in superiority clinical trials with multiple endpoints. Methods for sample size calculation in clin...

  20. Design of clinical trials for therapeutic cancer vaccines development.

    Science.gov (United States)

    Mackiewicz, Jacek; Mackiewicz, Andrzej

    2009-12-25

    Advances in molecular and cellular biology as well as biotechnology led to definition of a group of drugs referred to as medicinal products of advanced technologies. It includes gene therapy products, somatic cell therapeutics and tissue engineering. Therapeutic cancer vaccines including whole cell tumor cells vaccines or gene modified whole cells belong to somatic therapeutics and/or gene therapy products category. The drug development is a multistep complex process. It comprises of two phases: preclinical and clinical. Guidelines on preclinical testing of cell based immunotherapy medicinal products have been defined by regulatory agencies and are available. However, clinical testing of therapeutic cancer vaccines is still under debate. It presents a serious problem since recently clinical efficacy of the number of cancer vaccines has been demonstrated that focused a lot of public attention. In general clinical testing in the current form is very expensive, time consuming and poorly designed what may lead to overlooking of products clinically beneficial for patients. Accordingly regulatory authorities and researches including Cancer Vaccine Clinical Trial Working Group proposed three regulatory solutions to facilitate clinical development of cancer vaccines: cost-recovery program, conditional marketing authorization, and a new development paradigm. Paradigm includes a model in which cancer vaccines are investigated in two types of clinical trials: proof-of-principle and efficacy. The proof-of-principle trial objectives are: safety; dose selection and schedule of vaccination; and demonstration of proof-of-principle. Efficacy trials are randomized clinical trials with objectives of demonstrating clinical benefit either directly or through a surrogate. The clinical end points are still under debate.

  1. Indigenous women in Spanish American Historic Epic Poetry

    Directory of Open Access Journals (Sweden)

    Lise Segas

    2016-05-01

    Full Text Available Epic poetry has always been considered a masculine genre. The eruption of a group identity, masculine, white, aristocratic and christian, is the result of the representation and the exclusion of the Other, fictitious and singular, but in fact composed of a variety of ethnic groups, origins, sex, genders, religions and different degrees between fiction and historicity. Indeed, in the historical epic poetry which narrated the Conquest, except for the conquistadors listed at length and the indigenous kings and caciques, only few characters are distinguished by a historical individualisation. The Other, Amerindian and female, makes a shy entrance into history, into singularity, into the (historical and christian truth. It is the case of interpreters: Malinche and India Catalina, only historical native women that appear as part of the narrative plot as well as in the conquest enterprise in the poems of Lasso de la Vega (Cortés valeroso y Mexicana, Mexicana, of Juan de Castellanos (Elegías de varones ilustres de Indias and of Saavedra Guzmán (El peregrino indiano.

  2. Unfulfilled translation opportunities in industry sponsored clinical trials

    DEFF Research Database (Denmark)

    Smed, Marie; Getz, Kenneth A.

    2013-01-01

    in the industry and site representatives are changing. The process of clinical trials has increased in complexity over the years, resulting in additional management layers. Besides an increase in internal management layers, sponsors often also outsource various tasks related to clinical trials to a CRO (Contract...... Research Organization) and thereby adding another link in the relationships between site and sponsor. These changes are intended to optimize the time-consuming and costly trial phases; however, there is a need to study whether valuable knowledge and experience is compromised in the process. Limited......' knowledge gained in clinical trials is utilized by the industry. Responses from 451 global investigative site representatives are included in the study. The analysis of the extensive dataset reveals that the current processes of collaboration between sites and the industry restrict the leverage of valuable...

  3. Talking About Trials: Overcoming Bottlenecks in Clinical Communication

    Science.gov (United States)

    Participation in clinical trials by adult patients is dismally low. No one knows how many patients are offered the opportunity to enroll in trials. NCI researchers are studying how patients hear about trials, whether they discuss enrollment with their providers, and the roles they play in deciding to participate in a trial.

  4. Clinical trials in male hormonal contraception.

    Science.gov (United States)

    Nieschlag, Eberhard

    2010-11-01

    Research has established the principle of hormonal male contraception based on suppression of gonadotropins and spermatogenesis. All hormonal male contraceptives use testosterone, but only in East Asian men can testosterone alone suppress spermatogenesis to a level compatible with contraceptive protection. In Caucasians, additional agents are required of which progestins are favored. Clinical trials concentrate on testosterone combined with norethisterone, desogestrel, etonogestrel or depot-medroxyprogesterone acetate. The first randomized, placebo-controlled clinical trial performed by the pharmaceutical industry demonstrated the effectiveness of a combination of testosterone undecanoate and etonogestrel in suppressing spermatogenesis in volunteers. Copyright © 2010 Elsevier Inc. All rights reserved.

  5. Lung-MAP Launches: First Precision Medicine Trial From National Clinical Trials Network

    Science.gov (United States)

    A unique public-private collaboration today announced the initiation of the Lung Cancer Master Protocol (Lung-MAP) trial, a multi-drug, multi-arm, biomarker-driven clinical trial for patients with advanced squamous cell lung cancer. Squamous cell carcinom

  6. Performance Comparison of EPICS IOC and MARTe in a Hard Real-Time Control Application

    Science.gov (United States)

    Barbalace, Antonio; Manduchi, Gabriele; Neto, A.; De Tommasi, G.; Sartori, F.; Valcarcel, D. F.

    2011-12-01

    EPICS is used worldwide mostly for controlling accelerators and large experimental physics facilities. Although EPICS is well fit for the design and development of automation systems, which are typically VME or PLC-based systems, and for soft real-time systems, it may present several drawbacks when used to develop hard real-time systems/applications especially when general purpose operating systems as plain Linux are chosen. This is in particular true in fusion research devices typically employing several hard real-time systems, such as the magnetic control systems, that may require strict determinism, and high performance in terms of jitter and latency. Serious deterioration of important plasma parameters may happen otherwise, possibly leading to an abrupt termination of the plasma discharge. The MARTe framework has been recently developed to fulfill the demanding requirements for such real-time systems that are alike to run on general purpose operating systems, possibly integrated with the low-latency real-time preemption patches. MARTe has been adopted to develop a number of real-time systems in different Tokamaks. In this paper, we first summarize differences and similarities between EPICS IOC and MARTe. Then we report on a set of performance measurements executed on an x86 64 bit multicore machine running Linux with an IO control algorithm implemented in an EPICS IOC and in MARTe.

  7. A National Strategy to Develop Pragmatic Clinical Trials Infrastructure

    Science.gov (United States)

    Guise, Jeanne‐Marie; Dolor, Rowena J.; Meissner, Paul; Tunis, Sean; Krishnan, Jerry A.; Pace, Wilson D.; Saltz, Joel; Hersh, William R.; Michener, Lloyd; Carey, Timothy S.

    2014-01-01

    Abstract An important challenge in comparative effectiveness research is the lack of infrastructure to support pragmatic clinical trials, which compare interventions in usual practice settings and subjects. These trials present challenges that differ from those of classical efficacy trials, which are conducted under ideal circumstances, in patients selected for their suitability, and with highly controlled protocols. In 2012, we launched a 1‐year learning network to identify high‐priority pragmatic clinical trials and to deploy research infrastructure through the NIH Clinical and Translational Science Awards Consortium that could be used to launch and sustain them. The network and infrastructure were initiated as a learning ground and shared resource for investigators and communities interested in developing pragmatic clinical trials. We followed a three‐stage process of developing the network, prioritizing proposed trials, and implementing learning exercises that culminated in a 1‐day network meeting at the end of the year. The year‐long project resulted in five recommendations related to developing the network, enhancing community engagement, addressing regulatory challenges, advancing information technology, and developing research methods. The recommendations can be implemented within 24 months and are designed to lead toward a sustained national infrastructure for pragmatic trials. PMID:24472114

  8. Quality assessment of reports on clinical trials in the Journal of Hepatology

    DEFF Research Database (Denmark)

    Gluud, C; Nikolova, D

    1998-01-01

    Electronic searches on databases for randomised clinical trials and controlled clinical trials do not identify as many trials as handsearches, and trial reporting may be flawed. The aims were to identify all fully reported randomised clinical trials in the Journal of Hepatology and to make...... a qualitative assessment of the reporting....

  9. Anthropometry and the risk of lung cancer in EPIC

    NARCIS (Netherlands)

    Dewi, Nikmah Utami; Boshuizen, Hendriek C.; Johansson, Mattias; Vineis, Paolo; Kampman, Ellen; Steffen, Annika; Tjønneland, Anne; Halkjær, Jytte; Overvad, Kim; Severi, Gianluca; Fagherazzi, Guy; Boutron-Ruault, Marie Christine; Kaaks, Rudolf; Li, Kuanrong; Boeing, Heiner; Trichopoulou, Antonia; Bamia, Christina; Klinaki, Eleni; Tumino, Rosario; Palli, Domenico; Mattiello, Amalia; Tagliabue, Giovanna; Peeters, Petra H.; Vermeulen, Roel; Weiderpass, Elisabete; Gram, Inger Torhild; Huerta, José María; Agudo, Antonio; Sánchez, María José; Ardanaz, Eva; Dorronsoro, Miren; Quirós, José Ramón; Sonestedt, Emily; Johansson, Mikael; Grankvist, Kjell; Key, Tim; Khaw, Kay Tee; Wareham, Nick; Cross, Amanda J.; Norat, Teresa; Riboli, Elio; Fanidi, Anouar; Muller, David; Bueno-De-Mesquita, H.B.

    2016-01-01

    The associations of body mass index (BMI) and other anthropometric measurements with lung cancer were examined in 348,108 participants in the European Investigation Into Cancer and Nutrition (EPIC) between 1992 and 2010. The study population included 2,400 case patients with incident lung cancer,

  10. SPIRIT 2013 Statement: defining standard protocol items for clinical trials.

    Science.gov (United States)

    Chan, An-Wen; Tetzlaff, Jennifer M; Altman, Douglas G; Laupacis, Andreas; Gøtzsche, Peter C; Krle A-Jerić, Karmela; Hrobjartsson, Asbjørn; Mann, Howard; Dickersin, Kay; Berlin, Jesse A; Dore, Caroline J; Parulekar, Wendy R; Summerskill, William S M; Groves, Trish; Schulz, Kenneth F; Sox, Harold C; Rockhold, Frank W; Rennie, Drummond; Moher, David

    2015-12-01

    The protocol of a clinical trial serves as the foundation for study planning, conduct, reporting, and appraisal. However, trial protocols and existing protocol guidelines vary greatly in content and quality. This article describes the systematic development and scope of SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013, a guideline for the minimum content of a clinical trial protocol. The 33-item SPIRIT checklist applies to protocols for all clinical trials and focuses on content rather than format. The checklist recommends a full description of what is planned; it does not prescribe how to design or conduct a trial. By providing guidance for key content, the SPIRIT recommendations aim to facilitate the drafting of high-quality protocols. Adherence to SPIRIT would also enhance the transparency and completeness of trial protocols for the benefit of investigators, trial participants, patients, sponsors, funders, research ethics committees or institutional review boards, peer reviewers, journals, trial registries, policymakers, regulators, and other key stakeholders.

  11. The Role of Oncology Nurses in Discussing Clinical Trials.

    Science.gov (United States)

    Flocke, Susan A; Antognoli, Elizabeth; Daly, Barbara J; Jackson, Brigid; Fulton, Sarah E; Liu, Tasnuva M; Surdam, Jessica; Manne, Sharon; Meropol, Neal J

    2017-09-01

    To describe oncology nurses' experiences discussing clinical trials with their patients, and to assess barriers to these discussions.
. A qualitative study designed to elicit narratives from oncology nurses. 
. Community- and academic-based oncology clinics throughout the United States.
. 33 oncology nurses involved in direct patient care in community-based and large hospital-based settings. The sample was drawn from members of the Oncology Nursing Society. 
. In-depth interviews were conducted and analyzed using a 
immersion/crystallization approach to identify themes and patterns. The analyses highlight specific issues, examples, and contexts that present challenges to clinical trial discussions with patients.
. Oncology nurses view their roles as patient educators and advocates to be inclusive of discussion of clinical trials. Barriers to such discussions include lack of knowledge and strategies for addressing patients' common misconceptions and uncertainty about the timing of discussions.
. These data indicate that enabling nurses to actively engage patients in discussions of clinical trials requires educational interventions to build self-efficacy and close knowledge gaps. 
. Oncology nurses can play a critical role in advancing cancer care by supporting patients in decision making about clinical trial participation. This will require training and education to build their knowledge, reduce barriers, and increase their self-efficacy to fulfill this responsibility in various clinical settings.

  12. EPICS based control system for cryogenic plant at VECC

    International Nuclear Information System (INIS)

    Panda, Umashankar; Pal, Sandip; Mandal, Anupam; Dey, Ranadhir

    2012-01-01

    Cryogenic Plant of Variable Energy Cyclotron Centre consists of two Helium refrigerators (250W and 415W at the rate 4.5K), valve box with sub-cooler and associated sub systems like pure gas storage, helium purifier and impure gas recovery etc. The system also consists of 3.1K liters of liquid Nitrogen (LN 2 ) storage and delivery system. Many of the systems are procured from different suppliers and some are also developed in house. Due to the variety of systems and suppliers the control philosophy, communication protocols and component is also different. So the Supervisory control and data acquisition (SCADA) module has to be such that it can take care of the variance and bring everything into a common control platform. To solve this purpose EPICS (Experimental Physics and Industrial Control System) architecture has been adopted. EPICS is having the advantage of being open source, flexible and unlimited as compared to the commercial SCADA packages. (author)

  13. Trends in Canadian Respiratory Clinical Trials from 2001 to 2011

    Directory of Open Access Journals (Sweden)

    Claire Elizabeth Tacon

    2014-01-01

    Full Text Available Clinical research bridges patients’ unmet medical need with innovative medicines, increases knowledge acquisition by clinicians, and creates solutions to improve the sustainability and quality of the Canadian health care system and economy. The Canadian Institutes of Health Research and the Canadian Lung Association have recently raised concerns over declining research activities within the Canadian respiratory community. While there are currently >3000 ongoing clinical trials in Canada, the number of trials investigating common respiratory diseases is unknown. The objective of the present study was to monitor the trends in industry- and non-industry-sponsored respiratory clinical trials in Canada from 2001 to 2011. Trialtrove 2012 (Citeline, an Informa UK business, a database containing summarized clinical trial information regarding pharmaceutical products, was searched using common chronic respiratory disease terms: “allergic rhinitis”, “asthma”, “chronic obstructive pulmonary disease (COPD”, “cystic fibrosis”, “respiratory infections”, “pulmonary fibrosis” and “smoking cessation”. Over the past 10 years, the number of respiratory clinical trials conducted in Canada has increased (4.49 per year; P=0.004. From 2001 to 2011, the majority of trials were performed in asthma, followed closely by respiratory infections and COPD. Over the past decade, the number of trials investigating COPD and respiratory infections increased (P<0.05, while asthma trials showed a declining trend since 2007. Of the clinical trials performed during this 10-year period, the majority were in phase III, with a significant increase in the number of phase II trials (2.49 per year; P=0.008. However, certain trends observed are concerning and warrant further monitoring in the coming years.

  14. METHODOLOGICAL ISSUES OF CLINICAL TRIALS IN THE PEDIATRIC POPULATION

    Directory of Open Access Journals (Sweden)

    S.V. Topolyanskaya

    2010-01-01

    Full Text Available Conducting clinical trials on children population is a challenge both for organizers and pediatricians involved in trials. Difficulties in recruiting patients, a significant heterogenecity of the population, specific side reactions, difficulties in identifying the objective final points warrant the specific nature of designing clinical trials in pediatrics. The article illustrates key issues and methodology aspects: planning, design, control groups, patient recruitment. It stresses the need to carefully consider specific characteristics of a child’s system and multi-disciplinary approach involving a pediatrician at the early stages of planning, preliminary consultations with parent organizations, children and regulators.Key words: clinical trials, methodology, planning, design, patient recruitment, children. (Pediatric Pharmacology. – 2010; 7(5:6-10

  15. Issues and Challenges With Integrating Patient-Reported Outcomes in Clinical Trials Supported by the National Cancer Institute–Sponsored Clinical Trials Networks

    Science.gov (United States)

    Bruner, Deborah Watkins; Bryan, Charlene J.; Aaronson, Neil; Blackmore, C. Craig; Brundage, Michael; Cella, David; Ganz, Patricia A.; Gotay, Carolyn; Hinds, Pamela S.; Kornblith, Alice B.; Movsas, Benjamin; Sloan, Jeff; Wenzel, Lari; Whalen, Giles

    2016-01-01

    Purpose The objective of this report is to provide a historical overview of and the issues and challenges inherent in the incorporation of patient-reported outcomes (PROs) into multinational cancer clinical trials in the cancer cooperative groups. Methods An online survey of 12 cancer cooperative groups from the United States, Canada, and Europe was conducted between June and August of 2006. Each of the cooperative groups designated one respondent, who was a member of one of the PRO committees within the cooperative group. Results There was a 100% response rate, and all of the cancer clinical trial cooperative groups reported conducting PRO research. PRO research has been conducted in the cancer cooperative groups for an average of 15 years (range, 6 to 30 years), and all groups had multidisciplinary committees focused on the design of PRO end points and the choice of appropriate PRO measures for cancer clinical trials. The cooperative groups reported that 5% to 50% of cancer treatment trials and an estimated 50% to 75% of cancer control trials contained PRO primary and secondary end points. There was considerable heterogeneity among the cooperative groups with respect to the formal and informal policies and procedures or cooperative group culture towards PROs, investigator training/mentorship, and resource availability for the measurement and conduct of PRO research within the individual cooperatives. Conclusion The challenges faced by the cooperative groups to the incorporation of PROs into cancer clinical trials are varied. Some common opportunities for improvement include the adoption of standardized training/mentorship mechanisms for investigators for the conduct of PRO assessments and data collection and the development of minimal criteria for PRO measure acceptability. A positive cultural shift has occurred in most of the cooperative groups related to the incorporation of PROs in clinical trials; however, financial and other resource barriers remain and need

  16. Analysis of repeated measurement data in the clinical trials

    Science.gov (United States)

    Singh, Vineeta; Rana, Rakesh Kumar; Singhal, Richa

    2013-01-01

    Statistics is an integral part of Clinical Trials. Elements of statistics span Clinical Trial design, data monitoring, analyses and reporting. A solid understanding of statistical concepts by clinicians improves the comprehension and the resulting quality of Clinical Trials. In biomedical research it has been seen that researcher frequently use t-test and ANOVA to compare means between the groups of interest irrespective of the nature of the data. In Clinical Trials we record the data on the patients more than two times. In such a situation using the standard ANOVA procedures is not appropriate as it does not consider dependencies between observations within subjects in the analysis. To deal with such types of study data Repeated Measure ANOVA should be used. In this article the application of One-way Repeated Measure ANOVA has been demonstrated by using the software SPSS (Statistical Package for Social Sciences) Version 15.0 on the data collected at four time points 0 day, 15th day, 30th day, and 45th day of multicentre clinical trial conducted on Pandu Roga (~Iron Deficiency Anemia) with an Ayurvedic formulation Dhatrilauha. PMID:23930038

  17. Processes for Quality Improvements in Radiation Oncology Clinical Trials

    International Nuclear Information System (INIS)

    FitzGerald, T.J.; Urie, Marcia; Ulin, Kenneth; Laurie, Fran; Yorty, Jeffrey C.; Hanusik, Richard; Kessel, Sandy; Jodoin, Maryann Bishop; Osagie, Gani; Cicchetti, M. Giulia; Pieters, Richard; McCarten, Kathleen; Rosen, Nancy

    2008-01-01

    Quality assurance in radiotherapy (RT) has been an integral aspect of cooperative group clinical trials since 1970. In early clinical trials, data acquisition was nonuniform and inconsistent and computational models for radiation dose calculation varied significantly. Process improvements developed for data acquisition, credentialing, and data management have provided the necessary infrastructure for uniform data. With continued improvement in the technology and delivery of RT, evaluation processes for target definition, RT planning, and execution undergo constant review. As we move to multimodality image-based definitions of target volumes for protocols, future clinical trials will require near real-time image analysis and feedback to field investigators. The ability of quality assurance centers to meet these real-time challenges with robust electronic interaction platforms for imaging acquisition, review, archiving, and quantitative review of volumetric RT plans will be the primary challenge for future successful clinical trials

  18. Privacy and confidentiality in pragmatic clinical trials.

    Science.gov (United States)

    McGraw, Deven; Greene, Sarah M; Miner, Caroline S; Staman, Karen L; Welch, Mary Jane; Rubel, Alan

    2015-10-01

    With pragmatic clinical trials, an opportunity exists to answer important questions about the relative risks, burdens, and benefits of therapeutic interventions. However, concerns about protecting the privacy of this information are significant and must be balanced with the imperative to learn from the data gathered in routine clinical practice. Traditional privacy protections for research uses of identifiable information rely disproportionately on informed consent or authorizations, based on a presumption that this is necessary to fulfill ethical principles of respect for persons. But frequently, the ideal of informed consent is not realized in its implementation. Moreover, the principle of respect for persons—which encompasses their interests in health information privacy—can be honored through other mechanisms. Data anonymization also plays a role in protecting privacy but is not suitable for all research, particularly pragmatic clinical trials. In this article, we explore both the ethical foundation and regulatory framework intended to protect privacy in pragmatic clinical trials. We then review examples of novel approaches to respecting persons in research that may have the added benefit of honoring patient privacy considerations. © The Author(s) 2015.

  19. Clinical trials in allied medical fields: A cross-sectional analysis of World Health Organization International Clinical Trial Registry Platform

    Directory of Open Access Journals (Sweden)

    S. Kannan

    2016-03-01

    Conclusion: The number of clinical trials done in allied fields of medicine other than the allopathic system has lowered down, and furthermore focus is required regarding the methodological quality of these trials and more support from various organizations.

  20. Building trust and diversity in patient-centered oncology clinical trials: An integrated model.

    Science.gov (United States)

    Hurd, Thelma C; Kaplan, Charles D; Cook, Elise D; Chilton, Janice A; Lytton, Jay S; Hawk, Ernest T; Jones, Lovell A

    2017-04-01

    Trust is the cornerstone of clinical trial recruitment and retention. Efforts to decrease barriers and increase clinical trial participation among diverse populations have yielded modest results. There is an urgent need to better understand the complex interactions between trust and clinical trial participation. The process of trust-building has been a focus of intense research in the business community. Yet, little has been published about trust in oncology clinical trials or the process of building trust in clinical trials. Both clinical trials and business share common dimensions. Business strategies for building trust may be transferable to the clinical trial setting. This study was conducted to understand and utilize contemporary thinking about building trust to develop an Integrated Model of Trust that incorporates both clinical and business perspectives. A key word-directed literature search of the PubMed, Medline, Cochrane, and Google Search databases for entries dated between 1 January 1985 and 1 September 2015 was conducted to obtain information from which to develop an Integrated Model of Trust. Successful trial participation requires both participants and clinical trial team members to build distinctly different types of interpersonal trust to effect recruitment and retention. They are built under conditions of significant emotional stress and time constraints among people who do not know each other and have never worked together before. Swift Trust and Traditional Trust are sequentially built during the clinical trial process. Swift trust operates during the recruitment and very early active treatment phases of the clinical trial process. Traditional trust is built over time and operates during the active treatment and surveillance stages of clinical trials. The Psychological Contract frames the participants' and clinical trial team members' interpersonal trust relationship. The "terms" of interpersonal trust are negotiated through the psychological

  1. Phase 3 Oncology Clinical Trials in South Africa: Experimentation or Therapeutic Misconception?

    Science.gov (United States)

    Malan, Tina; Moodley, Keymanthri

    2016-02-01

    Although clinical research in oncology is vital to improve current understanding of cancer and to validate new treatment options, voluntary informed consent is a critical component. Oncology research participants are a particularly vulnerable population; hence, therapeutic misconception often leads to ethical and legal challenges. We conducted a qualitative study administering semi-structured questionnaires on 29 adult, Phase 3, oncology clinical trial participants at three different private oncology clinical trial sites in South Africa. A descriptive content analysis was performed to identify perceptions of these participants regarding Phase 3 clinical trials. We found that most participants provided consent to be included in the trial for self-benefit. More than half of the participants had a poor understanding of Phase 3 clinical trials, and almost half the participants believed the clinical trial did not pose any significant risk to them. The word "hope" was used frequently by participants, displaying clear optimism with regard to the clinical trial and its outcome. This indicated that therapeutic misconception does occur in the South African oncology research setting and has the potential to lead to underestimation of the risks of a Phase 3 clinical trial. Emphasizing the experimental nature of a clinical trial during the consent process is critical to address therapeutic misconception in oncology research. © The Author(s) 2016.

  2. Analisis Efektivitas Iklan Jejaring Sosial sebagai Media Promosi Menggunakan EPIC Model

    Directory of Open Access Journals (Sweden)

    Nur Hasanah

    2016-02-01

    Full Text Available Keberhasilan dalam sebuah iklan atau promosi yang sesuai dengan kebutuhan masyarakat terhadap Informasi Layanan Pendidikan di jejaring sosial sangat bergantung pada kemasan tampilan yang menarik dan berita yang disampaikan. Pencapaian keberhasilan tujuan promosi tersebut akan membutuhkan tindakan yang berkesinambungan dan tepat sasaran. Untuk mengetahui apakah Facebook Huma Harati itu efektif atau tidak maka perlu adanya pengukuran terhadap Facebook itu sendiri, salah satunya menggunakan metode EPIC (Empaty, Persuation, Impact, and Communication. Hasil analisa menyatakan bahwa Fanpage Huma Harati merupakan tempat yang efektif sebagai media promosi, hal ini terlihat dari nilai empaty, persuasiona, impact and communication yang diperoleh. Nilai rata-rata pada EPIC rate adalah 3,978, dimensi komunikasi mendapat nilai tertinggi dari dimensi lainnya yaitu 4,02. 

  3. A machine learning approach to identify clinical trials involving nanodrugs and nanodevices from ClinicalTrials.gov.

    Directory of Open Access Journals (Sweden)

    Diana de la Iglesia

    Full Text Available Clinical Trials (CTs are essential for bridging the gap between experimental research on new drugs and their clinical application. Just like CTs for traditional drugs and biologics have helped accelerate the translation of biomedical findings into medical practice, CTs for nanodrugs and nanodevices could advance novel nanomaterials as agents for diagnosis and therapy. Although there is publicly available information about nanomedicine-related CTs, the online archiving of this information is carried out without adhering to criteria that discriminate between studies involving nanomaterials or nanotechnology-based processes (nano, and CTs that do not involve nanotechnology (non-nano. Finding out whether nanodrugs and nanodevices were involved in a study from CT summaries alone is a challenging task. At the time of writing, CTs archived in the well-known online registry ClinicalTrials.gov are not easily told apart as to whether they are nano or non-nano CTs-even when performed by domain experts, due to the lack of both a common definition for nanotechnology and of standards for reporting nanomedical experiments and results.We propose a supervised learning approach for classifying CT summaries from ClinicalTrials.gov according to whether they fall into the nano or the non-nano categories. Our method involves several stages: i extraction and manual annotation of CTs as nano vs. non-nano, ii pre-processing and automatic classification, and iii performance evaluation using several state-of-the-art classifiers under different transformations of the original dataset.The performance of the best automated classifier closely matches that of experts (AUC over 0.95, suggesting that it is feasible to automatically detect the presence of nanotechnology products in CT summaries with a high degree of accuracy. This can significantly speed up the process of finding whether reports on ClinicalTrials.gov might be relevant to a particular nanoparticle or nanodevice

  4. A machine learning approach to identify clinical trials involving nanodrugs and nanodevices from ClinicalTrials.gov.

    Science.gov (United States)

    de la Iglesia, Diana; García-Remesal, Miguel; Anguita, Alberto; Muñoz-Mármol, Miguel; Kulikowski, Casimir; Maojo, Víctor

    2014-01-01

    Clinical Trials (CTs) are essential for bridging the gap between experimental research on new drugs and their clinical application. Just like CTs for traditional drugs and biologics have helped accelerate the translation of biomedical findings into medical practice, CTs for nanodrugs and nanodevices could advance novel nanomaterials as agents for diagnosis and therapy. Although there is publicly available information about nanomedicine-related CTs, the online archiving of this information is carried out without adhering to criteria that discriminate between studies involving nanomaterials or nanotechnology-based processes (nano), and CTs that do not involve nanotechnology (non-nano). Finding out whether nanodrugs and nanodevices were involved in a study from CT summaries alone is a challenging task. At the time of writing, CTs archived in the well-known online registry ClinicalTrials.gov are not easily told apart as to whether they are nano or non-nano CTs-even when performed by domain experts, due to the lack of both a common definition for nanotechnology and of standards for reporting nanomedical experiments and results. We propose a supervised learning approach for classifying CT summaries from ClinicalTrials.gov according to whether they fall into the nano or the non-nano categories. Our method involves several stages: i) extraction and manual annotation of CTs as nano vs. non-nano, ii) pre-processing and automatic classification, and iii) performance evaluation using several state-of-the-art classifiers under different transformations of the original dataset. The performance of the best automated classifier closely matches that of experts (AUC over 0.95), suggesting that it is feasible to automatically detect the presence of nanotechnology products in CT summaries with a high degree of accuracy. This can significantly speed up the process of finding whether reports on ClinicalTrials.gov might be relevant to a particular nanoparticle or nanodevice, which is

  5. Management of data from clinical trials using the ArchiMed system.

    Science.gov (United States)

    Duftschmid, Georg; Gall, Walter; Eigenbauer, Ernst; Dorda, Wolfgang

    2002-06-01

    Clinical trials constitute a key source of medical research and are therefore conducted on a regular basis at university hospitals. The professional execution of trials requires, among other things, a repertoire of tools that support efficient data management. Tasks that are essential for efficient data management in clinical trials include the following: the design of the trial database, the design of electronic case report forms, recruiting patients, collection of data, and statistical analysis. The present article reports the manner in which these tasks are supported by the ArchiMed system at the University of Vienna and Graz Medical Schools. ArchiMed is customized for clinical end users, allowing them to autonomously manage their clinical trials without having to consult computer experts. An evaluation of the ArchiMed system in 12 trials recently conducted at the University of Vienna Medical School shows that the individual system functions can be usefully applied for data management in clinical trials.

  6. Inclusion of Minority Patients in Breast Cancer Clinical Trials: The Role of the Clinical Trial Environment

    National Research Council Canada - National Science Library

    Kaplan, Celia P

    2007-01-01

    .... While inroads to increasing minority inclusion in breast cancer clinical trials have been made, recent reports continue to demonstrate lower enrollment among African Americans, Asian Americans...

  7. Quality assurance in clinical trials : a multi-disciplinary approach

    International Nuclear Information System (INIS)

    Cornes, D.

    2001-01-01

    Full text: Multi-disciplinary groups, such as medical physicists and radiation therapists, which work effectively together, can ensure continued improvements in radiation therapy quality. The same is also true for clinical trials, which have the added complication of requiring multi-institutional participation to collate sufficient data to effectively assess treatment benefits. It can be difficult to manage quality across all aspects of a multi-disciplinary and multi-institutional trial. A planned system of quality assurance is necessary to provide support for participating centres and facilitate a collaborative approach. To ensure protocol compliance a good relationship between the clinical trial group and treatment centre is idea with definition of mutual goals and objectives before and during the trial, and ongoing consultation and feedback throughout the trial process. To ensure good quality data and maximise the validity of results the study protocol must be strictly adhered to. Because of the need for meticulous attention to detail, both in treatment delivery and standards of documentation, clinical trials are often seen to further complicate the process of delivery of radiation therapy treatment. The Declaration of Helsinki and Good Clinical Practise Guidelines (adopted in May 1996, ICH) provide 'international ethical and scientific standards for designing, conducting, recording and reporting clinical research' and multi-disciplinary groups in each participating centre should also adhere to these guidelines. Copyright (2001) Australasian College of Physical Scientists and Engineers in Medicine

  8. Implementation of an anonymisation tool for clinical trials using a clinical trial processor integrated with an existing trial patient data information system

    NARCIS (Netherlands)

    Aryanto, Kadek Y. E.; Broekema, Andre; Oudkerk, Matthijs; van Ooijen, Peter M. A.

    To present an adapted Clinical Trial Processor (CTP) test set-up for receiving, anonymising and saving Digital Imaging and Communications in Medicine (DICOM) data using external input from the original database of an existing clinical study information system to guide the anonymisation process. Two

  9. Iron chelation therapy with deferasirox in patients with aplastic anemia: a subgroup analysis of 116 patients from the EPIC trial

    DEFF Research Database (Denmark)

    Lee, Jong Wook; Yoon, Sung-Soo; Shen, Zhi Xiang

    2010-01-01

    The prospective 1-year Evaluation of Patients' Iron Chelation with Exjade (EPIC) study enrolled a large cohort of 116 patients with aplastic anemia; the present analyses evaluated the efficacy and safety of deferasirox in this patient population. After 1 year, median serum ferritin decreased...... neutrophil and platelet counts remained stable during treatment, and there were no drug-related cytopenias. This prospective dataset confirms the efficacy and well characterizes the tolerability profile of deferasirox in a large population of patients with aplastic anemia. This study was registered at www...

  10. Juvencus and the biblical epic: specificity and literary criticism

    Directory of Open Access Journals (Sweden)

    Elena María Calderón de Cuervo

    2015-04-01

    Full Text Available Latin Christian poetry has emerged in  Constantine Era and flourished between 400 and 800. It has a fundamental role in the development of literary theory and critical discourse, because, except for Prudencio, the rest of the poets of this first period has chosen by the adaptation of the classical canon to Christian themes. The Christian epic is therefore one of the first genres and begins as biblical epic. The first major work of this type is the Gospel Harmony from the Spanish poet Juvencus, until 330. This work begins a long series of biblical poetry, Latin at first, but after this there is its continuation in the vernaculars, like Caedmon, Cynewulf, The Heliand, The Passion by Clermont till Ojeda, Milton and Klopstock.The dedication to the established authority , the subordination of the art´s purpose for the salvation of the soul as well as the desire to legitimize poetry with Christian arguments remain as fundamental premises in the construction of gender. When the modern epic apear, its compromise with new theological Aporia will not lose those extraliterary requirements from provenance.Keywords: Latin Christian poetry; Constantine Era; Virgil.

  11. Improved outcome in acute myeloid leukemia patients enrolled in clinical trials

    DEFF Research Database (Denmark)

    Østgård, Lene Sofie Granfeldt; Nørgaard, Mette; Sengeløv, Henrik

    2016-01-01

    Clinical trials are critical to improve AML treatment. It remains, however, unclear if clinical trial participation per se affects prognosis and to what extent the patients selected for trials differ from those of patients receiving intensive therapy off-trial.We conducted a population-based coho...

  12. Development of a cancer clinical trials multi-media intervention: clinical trials: are they right for you?

    Science.gov (United States)

    Wells, Kristen J; Quinn, Gwendolyn P; Meade, Cathy D; Fletcher, Michelle; Tyson, Dinorah Martinez; Jim, Heather; Jacobsen, Paul B

    2012-08-01

    To describe processes used to develop a multi-media psycho-educational intervention to prepare patients for a discussion about cancer clinical trials (CTs). Guided by a Steering Committee, formative research was conducted to develop an informative and engaging tool about cancer CTs. Twenty-three patients and caregivers participated in formative in-depth interviews to elicit information about perceptions of cancer CTs to inform production of a new media product. Formative research revealed participants had concerns about experimentation, held beliefs that cancer CTs were for patients who had no other treatment options, and wanted a balance of information about pros and cons of CT participation. The value of physicians as credible spokespersons and the use of patients as role-models were supported. Using iterative processes, the production team infused the results into creation of a multimedia psycho-educational intervention titled Clinical Trials: Are they Right for You? An intervention, developed through an iterative consumer-focused process involving multiple stakeholders and formative research, may result in an engaging informative product. If found to be efficacious, Clinical Trials: Are they Right for You? is a low-cost and easily disseminated multimedia psycho-educational intervention to assist cancer patients with making an informed decision about cancer CTs. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

  13. [Ethical principles of clinical trials in minors].

    Science.gov (United States)

    Koch, H J; Raschka, C

    2002-12-05

    Clinical trials in volunteers and patients are essential to ensure rational treatment of patients. As a rule, drugs are routinely developed for adults, but children are excluded. A major reason for this restriction are ethical justifications, in particular the lack of autonomy on the part of children. The principle of fairness, however, requires that everyone should benefit from progress. Industry, science and society are therefore called upon to find ways of making available safe and adequate treatment for children as quickly as possible, by defining the required conditions for pediatric clinical trials. Important principles are minimal risk, minimal invasivity, rapid decision-making, and careful documentation of trial results. Dynamic ethical principles, such as autonomy and competence in adolescents must be considered on equal footing with existing international GCP guidelines. Aspects of child psychology indicate that the autonomy of adolescents should be respected. Where economic incentives for such trials are absent, for example, in the case of non-pharmacological problems, pediatric trials must be considered a task for society as a whole.

  14. Current globalization of drug interventional clinical trials: characteristics and associated factors, 2011-2013.

    Science.gov (United States)

    Jeong, Sohyun; Sohn, Minji; Kim, Jae Hyun; Ko, Minoh; Seo, Hee-Won; Song, Yun-Kyoung; Choi, Boyoon; Han, Nayoung; Na, Han-Sung; Lee, Jong Gu; Kim, In-Wha; Oh, Jung Mi; Lee, Euni

    2017-06-21

    Clinical trial globalization is a major trend for industry-sponsored clinical trials. There has been a shift in clinical trial sites towards emerging regions of Eastern Europe, Latin America, Asia, the Middle East, and Africa. Our study objectives were to evaluate the current characteristics of clinical trials and to find out the associated multiple factors which could explain clinical trial globalization and its implications for clinical trial globalization in 2011-2013. The data elements of "phase," "recruitment status," "type of sponsor," "age groups," and "design of trial" from 30 countries were extracted from the ClinicalTrials.gov website. Ten continental representative countries including the USA were selected and the design elements were compared to those of the USA. Factors associated with trial site distribution were chosen for a multilinear regression analysis. The USA, Germany, France, Canada, and United Kingdom were the "top five" countries which frequently held clinical trials. The design elements from nine continental representative countries were quite different from those of the USA; phase 1 trials were more prevalent in India (OR 1.517, p globalization of clinical trials in the emerging regions of Asia, South Africa, and Eastern Europe developed in parallel with the factors of economic drive, population for recruitment, and regulatory constraints.

  15. Phase II cancer clinical trials for biomarker-guided treatments.

    Science.gov (United States)

    Jung, Sin-Ho

    2018-01-01

    The design and analysis of cancer clinical trials with biomarker depend on various factors, such as the phase of trials, the type of biomarker, whether the used biomarker is validated or not, and the study objectives. In this article, we demonstrate the design and analysis of two Phase II cancer clinical trials, one with a predictive biomarker and the other with an imaging prognostic biomarker. Statistical testing methods and their sample size calculation methods are presented for each trial. We assume that the primary endpoint of these trials is a time to event variable, but this concept can be used for any type of endpoint.

  16. Towards a framework of success factors for clinical trials

    DEFF Research Database (Denmark)

    Buonansegna, Erika; Salomo, Søren; Maier, Anja

    2012-01-01

    Clinical trials in the pharmaceutical industry are the most critical part of the drug development process with respect to obtaining the market approval from the authorities. Clinical trials are highly expensive, time-consuming and often unsuccessful. While new product development (NPD) literature...

  17. Quantifying and visualizing site performance in clinical trials

    OpenAIRE

    Eric Yang; Christopher O'Donovan; JodiLyn Phillips; Leone Atkinson; Krishnendu Ghosh; Dimitris K. Agrafiotis

    2018-01-01

    Background: One of the keys to running a successful clinical trial is the selection of high quality clinical sites, i.e., sites that are able to enroll patients quickly, engage them on an ongoing basis to prevent drop-out, and execute the trial in strict accordance to the clinical protocol. Intuitively, the historical track record of a site is one of the strongest predictors of its future performance; however, issues such as data availability and wide differences in protocol complexity can co...

  18. Gateways to clinical trials.

    Science.gov (United States)

    Bayés, M; Rabasseda, X; Prous, J R

    2005-04-01

    Gateways to Clinical Trials is a guide to the most recent clinical trials in current literature and congresses. The data in the following tables has been retrieved from the Clinical Trials Knowledge Area of Prous Science Integrity, the drug discovery and development portal, http://integrity. prous.com. This issue focuses on the following selection of drugs: ABX-IL-8, Acclaim, adalimumab, AGI-1067, alagebrium chloride, alemtuzumab, Alequel, Androgel, anti-IL-12 MAb, AOD-9604, aripiprazole, atomoxetine hydrochloride; Biphasic insulin aspart, bosentan, botulinum toxin type B, bovine lactoferrin, brivudine; Cantuzumab mertansine, CB-1954, CDB-4124, CEA-TRICOM, choriogonadotropin alfa, cilansetron, CpG-10101, CpG-7909, CTL-102, CTL-102/CB-1954; DAC:GRF, darbepoetin alfa, davanat-1, decitabine, del-1 Genemedicine, dexanabinol, dextofisopam, dnaJP1, dronedarone hydrochloride, dutasteride; Ecogramostim, eletriptan, emtricitabine, EPI-hNE-4, eplerenone, eplivanserin fumarate, erlotinib hydrochloride, ertapenem sodium, escitalopram oxalate, esomeprazole magnesium, etoricoxib, ezetimibe; Falecalcitriol, fingolimod hydrochloride; Gepirone hydrochloride; HBV-ISS, HSV-2 theracine, human insulin; Imatinib mesylate, Indiplon, insulin glargine, ISAtx-247; L612 HuMAb, levodopa/carbidopa/entacapone, lidocaine/prilocaine, LL-2113AD, lucinactant, LY-156735; Meclinertant, metelimumab, morphine hydrochloride, morphine-6-glucuronide; Natalizumab, nimotuzumab, NX-1207, NYVAC-HIV C; Omalizumab, onercept, osanetant; PABA, palosuran sulfate, parathyroid hormone (human recombinant), parecoxib sodium, PBI-1402, PCK-3145, peginterferon alfa-2a, peginterferon alfa-2b, peginterferon alfa-2b/ribavirin, pemetrexed disodium, pimecrolimus, PINC, pregabalin; Ramelteon, rasagiline mesilate, rasburicase, rimonabant hydrochloride, RO-0098557, rofecoxib, rosiglitazone maleate/metformin hydrochloride; Safinamide mesilate, SHL-749, sitaxsentan sodium, sparfosic acid, SprayGel, squalamine, St. John's Wort

  19. CliniProteus: A flexible clinical trials information management system

    Science.gov (United States)

    Mathura, Venkatarajan S; Rangareddy, Mahendiranath; Gupta, Pankaj; Mullan, Michael

    2007-01-01

    Clinical trials involve multi-site heterogeneous data generation with complex data input-formats and forms. The data should be captured and queried in an integrated fashion to facilitate further analysis. Electronic case-report forms (eCRF) are gaining popularity since it allows capture of clinical information in a rapid manner. We have designed and developed an XML based flexible clinical trials data management framework in .NET environment that can be used for efficient design and deployment of eCRFs to efficiently collate data and analyze information from multi-site clinical trials. The main components of our system include an XML form designer, a Patient registration eForm, reusable eForms, multiple-visit data capture and consolidated reports. A unique id is used for tracking the trial, site of occurrence, the patient and the year of recruitment. Availability http://www.rfdn.org/bioinfo/CTMS/ctms.html. PMID:21670796

  20. [Maraviroc: clinical trials results].

    Science.gov (United States)

    Chidiac, C; Katlama, C; Yeni, P

    2008-03-01

    Just over a decade after identification of chemokine receptors CCR5 and CXCR4 as coreceptors for HIV, maraviroc (Celsentri), the first CCR5 antagonist, has recently obtained its Marketing Authorization in the United States and Europe, for treatment of treatment-experienced adult patients infected with only CCR5-tropic HIV-1 detectable. CCR5 antagonists, after fusion inhibitor enfuvirtide available since 2003, also belong to entry inhibitors. These molecules, unlike previous antiretrovirals, do not target the virus but its target cell by blocking viral penetration. Maraviroc has shown its clinical efficacy in patients failing other antiretroviral classes. Its safety profile was similar to placebo in two large phase III trials. However, careful assessment of both hepatic and immunologic safety of this new therapeutic class is needed. Viral tropism testing has to be investigated before using maraviroc in the clinic, because CCR5 antagonists are not active against CXCR4 viruses. For the moment indicated for the treatment-experienced patient population, maraviroc could in the future benefit to other types of patients, depending on ongoing trials results.

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