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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, the 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 is a report of that workshop.
Most of the possible content fields for a clinical trial registry are not being debated. The discussions at the workshop centered on the following five concepts:
- The purposes of a registry;
- Inclusion or exclusion of exploratory trials;
- The need for a delayed disclosure mechanism for certain fields in the registry at the time of trial initiation (hypothesis statement, primary and secondary outcome measures, and projected year of trial completion);
- The timing and format for reporting results of completed trials; and
- The appropriate roles for Institutional Review Boards, the FDA, and others in ensuring compliance.
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