1
Summary
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.
In December 2004, after the International Committee of Medical Journal Editors (ICMJE) published its requirements for clinical trial registration, the Institute of Medicine (IOM) Board on Health Sciences Policy invited medical journal editors, pharmaceutical and biotech industry leaders, and representatives from the National Institutes of Health (NIH) and Food and Drug Administration (FDA) to discuss public access to biomedical and clinical research data. Following that meeting, the IOM appointed a committee whose members held further discussions with medical journal editors and pharmaceutical and biotech industry leaders regarding possible components and mechanisms for implementation of a clinical trial registry that would meet the public’s need for disclosure while supporting innovation in development of new therapeutics. Based on those discussions, the following goals were suggested for a central registry:
-
To provide patients and their health care providers with adequate and reliable information about clinical trials that may be enrolling patients.
-
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,
-
primary and secondary outcome measures, and projected year of trial completion).
-
The timing and format for reporting results of completed trials.
-
The appropriate roles for Institutional Review Boards, the FDA, and others in ensuring compliance.
Questions remained at the end of the workshop, but activities toward implementing and expanding clinical trial registration have continued. Since September 2005, any trial beginning after July 1, 2005, must have registered before enrolling the first patient. Any trial that began before that date must have been registered prior to submitting the article to one of the ICMJE journals. The international pharmaceutical industry working with NLM has begun registering all but exploratory clinical trials on ClinicalTrials.gov, and providing the results of clinical trials on marketed products on ClinicalStudyResults.gov, an Internet database launched September 2004 by the Pharmaceutical Research and Manufacturers of America. The World Health Organization has finalized its position on global clinical trial registration and convened a group to develop a mechanism for advising on requests to delay release of one or more data items until a specified date.
