Alexa T. McCray, PhD
Access to information about clinical trials is important to researchers, health care professionals, and patients. Many have argued for the establishment of clinical trials registries, citing their substantial benefits. Although some registries do exist, it has been difficult to create comprehensive, easily accessible systems. This paper briefly reviews existing registries, discusses the challenges in building registries, and reviews some of their benefits. The paper concludes with a description of a new, extensive Web–based registry called ClinicalTrials.gov (http://clinicaltrials.gov/), which was developed at the National Institutes of Health (NIH) by the National Library of Medicine as a result of recent legislation calling for a comprehensive, publicly accessible registry of clinical trials. The first version of the system became available in late February 2000 and contains information about approximately 5000 trials. The first release contains primarily NIH-sponsored trials, and new trials are regularly added to the system. Subsequent versions will contain information about trials sponsored by other federal agencies and by the private sector. The system was developed in accordance with basic informatics principles, including adherence to standards, usability considerations, and iterative testing and evaluation.
The case for registering all clinical trials … is now unanswerable. The public has the right to know what research is being funded. Researchers and research funders don't want to waste resources repeating trials already under way. And those conducting systematic reviews need to be able to identify all trials begun on a subject to avoid the problem of publication bias (1).
A registry of clinical trials (whether federally or privately funded) of experimental treatments for serious or life-threatening diseases and conditions … which provides a description of the purpose of each experimental drug, either with the consent of the protocol sponsor, or when a trial to test effectiveness begins. Information provided shall consist of eligibility criteria for participation in the clinical trials, a description of the location of trial sites, and a point of contact for those wanting to enroll in the trial, and shall be in a form that can be readily understood by members of the public (16).
Clinical Trials Registries
Information Given in the ClinicalTrials.gov Record Display
From the National Library of Medicine, Bethesda, Maryland.
Acknowledgments: The author thanks Kay Dickersin, Valerie Florance, and Brian Haynes for their helpful comments on an earlier version of the manuscript.
Requests for Single Reprints: Alexa T. McCray, PhD, National Library of Medicine, 8600 Rockville Pike, Bethesda, MD 20894; e-mail, firstname.lastname@example.org.
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McCray AT. Better Access to Information about Clinical Trials. Ann Intern Med. ;133:609–614. doi: 10.7326/0003-4819-133-8-200010170-00013
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Published: Ann Intern Med. 2000;133(8):609-614.
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Print ISSN: 0003-4819 | Online ISSN: 1539-3704
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