Developing a National Registry of Pharmacologic and Biologic Clinical Trials: Workshop Report

Institute of Medicine

doi:10.17226/11561

Developing a National Registry of Pharmacologic and Biologic Clinical Trials:Workshop Report (2006)

Proceedings

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Developing a National Registry of Pharmacologic and Biologic Clinical Trials

Workshop Report(2006)

Proceedings

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Overview

Contributors

Institute of Medicine; Board on Health Sciences Policy; Committee on Clinical Trial Registries

Description

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.

Topics

Suggested Citation

Institute of Medicine. 2006. Developing a National Registry of Pharmacologic and Biologic Clinical Trials: Workshop Report. Washington, DC: The National Academies Press.https://doi.org/10.17226/11561.

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Publication Info

124 pages |6 x 9
ISBNs:

Paperback: 978-0-309-10078-6
Ebook: 978-0-309-18054-2

DOI: https://doi.org/10.17226/11561

Contents

Table of Contents	skim chapter
Front Matter	i-xx
1 Summary	1-4
2 The Need for Clinical Trial Registries	5-8
3 Current Registry Activities	9-18
4 Content of a Clinical Trial Registry	19-34
5 Implementation Issues	35-42
6 Conclusion and Next Steps	43-46
References	47-48
Appendix A Participants and Invited Experts - Between December 1, 2004 and June 27, 2005	49-50
Appendix B Workshop Agenda, Speakers, Panelists, and Participants - June 27, 2005	51-62
Appendix C Sec. 113 of the Food and Drug Administration Modernization Act of 1997; Guidance for Industry: Information Programs on Clinical Trials...	63-80
Appendix D Published Journal Editorials	81-90
Appendix E Joint Position on the Disclosure of Clinical Trial Information via Clinical Trial Registries and Databases	91-94
Appendix F Illustrative Data Fields for the Results Summary	95-96
Appendix G Biographical Sketches of Committee Members	97-104

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