Developing a National Registry of Pharmacologic and Biologic Clinical Trials

Book Reviews: Medical journal editors, the pharmaceutical industry, and the World Health Organization have all proposed some form of clinical trial registry for drugs and biologics. Other organizations, including the American Medical Association and the Association of American Medical Colleges, have supported the creation of a registry. These proposals have several features in common, such as public accessibility, broad inclusion of clinical trials, and most of the key data elements. However, so far, the parties have disagreed as to inclusion of other elements such as trial results and have not determined the mechanisms for implementation and compliance. To help make progress on this issue, the Institute of Medicines (IOMs) Board on Health Sciences Policy (HSP) of the National Academies hosted discussions among interested parties, leading to this report.

On December 1, 2004, HSP invited leaders from several of the major constituencies to discuss areas of common ground and unresolved issues (see Appendix A for participants). Following that meeting, the Board formed a committee, some of whose members held additional discussions with journal editors and pharmaceutical and biotech leaders about the merits and importance of specific elements to be included in a workable clinical trial registry for drugs and biologics.

The IOM committee posted background material regarding these issues on its website prior to convening a workshop on June 27, 2005, in Washington, D.C. The 150 workshop participants included public advocate groups, medical journal editors, pharmaceutical representatives, government representatives, and others (see Appendix B for the agenda, speakers, and participants).

This report summarizes the views expressed by workshop participants and includes background information to provide the context for workshop discussion based on the committees planning work. It includes information and perspectives gathered prior to and at the workshop, describing progress made toward a national registry for clinical trials and points for further consideration. Chapter 1 is a summary of the issues surrounding creation of a clinical trial registry and the contributions of this project. Chapter 2 describes the importance of a national clinical trial registry, drawing together views expressed throughout this project. Chapter 3 describes diverse perspectives and activities toward creating a national clinical trial registry. Chapter 4, describing potential elements of a registry, intersperses background material with comments made by workshop participants. Chapter 5, on implementation issues, also includes background material interspersed with comments made by participants.

Although the Committee on Clinical Trial Registries is responsible for the overall quality and accuracy of the report as a record of what transpired at the workshop, the views contained in this report are not necessarily those of the committee. The purpose of the workshop and the resulting report is to continue to elicit broad input to inform future efforts to build a clinical trial registry that supports the public health.

Bibliographical Data of Developing a National Registry of Pharmacologic and Biologic Clinical Trials

Reference Type: Book
Record Number: xx
Author: Institute of Medicine, Board on Health Sciences Policy
Year: 2006
Place Published: Washington, D.C.
Publisher: National Academies Press
Number of Pages: 124
Edition: 1st
ISBN -10: 030910078X
ISBN-13: 978-0309100786
Kindle Available: NO
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