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DHHS Recommended to Establish Registry For U.S. Clinical Trials

By Pharmaceutical Processing | June 21, 2004

     CHICAGO, IL (June 21, 2004) – The American Medical Association (AMA) House of Delegates called for the Department of Health and Human Services to establish a comprehensive registry for clinical trials conducted in the United States.

The registry would ensure that trials with negative and positive results are publicly available by providing every clinical trial with a unique identification and ensuring publication or placement on an electronic database of results from registered trials.

The policy calls for the AMA to urge institutional review boards that must approve research involving human subjects to consider registration of clinical trials as a condition for approval.

The AMA cited concern about the influence commercial support of drug trials may have on this publication bias. In studying the issue, the AMA also found direct sources of publication bias. Confirmatory trials, trials with negative results and trials that show no significant result are less likely to be published, according to the AMA.

The policies were based on recommendations put forth in a report from the AMA’s Council on Scientific Affairs.

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