The American Medical Association is calling on HHS to create a registry of all clinical trials to help ensure publication of negative findings.

The AMA House of Delegates voted to recommend that HHS "establish a comprehensive registry for all clinical trials conducted in the U.S." at the association's annual meeting in Chicago June 15

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

The recommendation was made in the form of an amendment to the ¹ Report of the Council on Scientific Affairs on "Influence of Funding Source on Outcome, Validity, and Reliability of Pharmaceutical Research" (Resolution 514, A-03).

The resolution was introduced by the American Psychiatric Association and the American Academy of Child & Adolescent Psychiatry.

AMA is also urging institutional review boards "to consider registration of clinical trials as a condition for approval" of protocols.

The policy is intended to fight publication bias by authors and journal editors, who tend to favor studies with positive results, and ensure that data gathered by companies will be released to the public, AMA said.

Issues related to publication bias were highlighted in a suit filed by New York Attorney General Eliot Spitzer alleging that GlaxoSmithKline suppressed negative studies of Paxil in children. GSK has responded by posting all of its Paxil study reports on the internet and launching a company-wide clinical trial register (see ² Also see "GSK Posts Paxil Pediatric Data On Website; Plans U.S. Clinical Trial Register" - Pink Sheet, 21 June, 2004.).

The AMA proposal would go beyond the current ClinicalTrials.gov database, for which only studies of serious or life-threatening diseases are required to be included. Even in areas like cancer research, however, compliance with the public listing requirement is low (³ Also see "ClinicalTrials.gov Noncompliance Remains An FDA Concern" - Pink Sheet, 17 May, 2004., p. 24).

HHS Registry Of Clinical Trials Proposed By AMA To Limit Publication Bias

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