NCPA - National Center for Policy Analysis


July 26, 2004

Registration of information from clinical drug trials in the United States is haphazard at best, says Robert Steinbrook in the New England Journal of Medicine.

  • In the United States, "public registration" of clinical trials and their results is only required for some trials.
  • Although the Food and Drug Administration (FDA) releases extensive information about trials that support the approval of a drug coming to market, there is no comprehensive public database for trials where a drug or device fails.

According to Steinbrook, any national registry must include all trials by sponsored government agencies, universities, and private companies. Every trial should have a unique identifier, and all results from registered trials should be made public.

An international system of registries would go even further, says Steinbrook, but such a huge project would require the coordination of a number of countries and their medical systems.

Source: Robert Steinbrook, M.D., "Public Registration of Clinical Trials," New England Journal of Medicine, July 22, 2004.


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