Developing a National Registry of Pharmacologic and Biologic Clinical Trials: Workshop Report
National Academies Press, Jun 16, 2006 - Medical - 101 pages
To improve public confidence in clinical research, a number of public and private groups have called for a publicly accessible, comprehensive, and transparent registry of relevant information on clinical trials for drugs and biologics. The public and various entities within the medical community (health care providers, researchers, medical journal editors, pharmaceutical companies, health insurers, and regulators) have different expectations and perceived needs regarding a public clinical trial registry.
The IOM Committee on Clinical Trial Registries hosted a workshop on June 27, 2005, to obtain much-needed input from members of the public, public advocate groups, and the broader community of journal editors, pharmaceutical and biotech leaders, NIH, and the FDA. Participants discussed the data elements that have been at the core of debate and commented on issues of compliance and implementation of a national clinical trial registry.
Developing a National Registry of Pharmacologic and Biologic Clinical Trials: Workshop Report inlcudes discussions at the workshop centered on the following five concepts, and are described within this report: 1) Purpose, 2) Which Trials to Include, 3) Delayed Disclosure Mechanism, 4) Reporting Results of Completed Trials, and 5) Compliance.
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CURRENT REGISTRY ACTIVITIES
CONTENT OF A CLINICAL TRIAL REGISTRY
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American Medical Association Annals of Internal approved Biogen Idec Biomedical Cancer clinical research clinical trial information clinical trial registry clinical trial results Clinical Trials Data ClinicalTrials.gov compliance data fields Director discussions disease or condition diseases and conditions Drazen Drug Administration Editor-in-Chief Eli Lilly endpoints enrollment Evaluation and Research exploratory trials federal Food and Drug GlaxoSmithKline Health Sciences Policy ICMJE Institute of Medicine Institutes of Health Institutional Review Board Internal Medicine intervention investigational John Hoey Joint Position June 27 Library of Medicine life-threatening diseases Lilly and Company marketed Medical Journal Editors National Academy National Institutes National Library participants patient Pediatrics Perlegen Sciences pharmaceutical industry Phase PhRMA protocol Public Health public trust publicly accessible Section 113 serious or life-threatening sponsor submit information summary trial sites Trials Data Bank University School Vice President workshop World Health Organization