Food And Drug Administration Modernization Act Of 1997

Author : Committee on Clinical Trial Registries
Publisher :
ISBN 13 :
Total Pages : 128 pages
Book Rating : 4.3/5 (91 download)

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Download or read book Developing a National Registry of Pharmacologic and Biologic Clinical Trials written by Committee on Clinical Trial Registries and published by . This book was released on 2006-06-16 with total page 128 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.