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Developing a National Registry of Pharmacologic and Biologic Clinical Trials: Workshop Summary
To provide health care providers, patients, and others with the results of a clinical trial once the trial is completed and the product is available for prescription.
To link each clinical trial initiated with a reported outcome, thereby preventing selective or biased reporting of results.
To meet the first three goals in a way that protects proprietary research data, as necessary, and preserves innovation.
The committee’s discussions also suggested that the next steps toward implementing a registry that accomplishes these goals would likely include the following:
Identification of uniform standards for data disclosure—both at trial inception and for completed trials—that apply to all entities conducting human clinical trials, whether privately or publicly funded.
Creation of a process that balances the interest in protecting confidential and proprietary research data with the need to allow the broadest access possible to clinical trial information.
Creation of a mechanism to ensure compliance, with associated consequences for noncompliance.
Assignment of responsibilities for developing and managing the registry to a nonprofit organization or trusted government agency, such as the National Library of Medicine (NLM).
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.
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,