Registration of Clinical Trials — Voluntary or Mandatory?

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Abstract
Should the public registration of clinical trials be voluntary or mandatory, as bills introduced earlier this month in Congress would require? What trials should be included? Proposals for mandatory registration have gained support because of concerns about the effects on medical practice of concealing negative data, concerns about the protection of research subjects, particularly in studies of investigational products, and concerns about the availability of information to researchers, physicians, people seeking to enroll as subjects in trials, and the public.1,2 Critics argue that mandatory registration could reveal information that manufacturers consider proprietary, such as the results of small or exploratory studies, or impede the development of drugs or devices by forcing the release of research strategies to competitors. Proponents argue that these risks must be weighed against the benefits of registration and that registration will only be meaningful if all trials that should be registered are. They also doubt that voluntary efforts will work.

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