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Registration of Clinical Trials
- Christine Laine, MD, MPH, Senior Deputy Editor; and
- Harold C. Sox, MD, Editor
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IN RESPONSE:
Drs. Braillon, Dubois, and Slama raise 2 concerns about the policy on trial registration that the ICMJE announced in September 2004: the ICMJE definition of a clinical trial and the criteria of acceptable registries. For the purposes of the policy, the ICMJE defines a clinical trial as “any research project that prospectively assigns human subjects to intervention or comparison groups to study the cause-and-effect relationship between a medical intervention and a health outcome.” This definition focuses the policy on studies with the most immediate potential relevance to clinical practice, which are also the studies for which selective reporting poses the potential dangers. The ICMJE defined the characteristics of acceptable registries first and then looked to see whether any existing registries met these criteria. Because EudraCT is not open to the public, this registry does not satisfy the main purpose of ICMJE's advocacy of trials registration, which is to allow anyone to learn of any trial's existence and its important characteristics. The ICMJE hopes that existing and developing registries will consider how they might better enable all interested individuals to learn about a clinical trial. Links among registries and unique trial identification numbers will help to minimize the need for investigators to register in multiple places.
