The Pharmaceutical Research & Manufacturers of America will launch a registry of clinical trial results Oct. 1.

The website, clinicalstudyresults.org, will be launched by PhRMA, but the trade association hopes to spin off the database to an independent, non-governmental third party.

PhRMA unveiled its proposal for a clinical study results database at a press conference in Washington, D.C. Sept. 7.

The announcement came two days before a congressional hearing on the reporting of pediatric studies of antidepressants and the expected publication of an editorial by medical journal editors advocating registration of studies as a prerequisite for publication (¹ Also see "Medical Journals To Propose Making Trial Registry Condition For Publication" - Pink Sheet, 3 September, 2004.).

The database "will contain the results of all controlled clinical trials (mainly Phase III and IV studies), both positive and negative, completed since October 2002 for PhRMA member company drug products approved in the U.S.," PhRMA said.

The database is voluntary for PhRMA members, but the association expects virtually all U.S.-marketed products to be included. Non-PhRMA members will also be able to post trial results, the organization said.

The database will include a link to the drug's label if available, a bibliography of published studies, and a "complete summary of each hypothesis-testing trial…regardless of outcome, that has not been published in a peer-reviewed medical journal."

PhRMA defines a "hypothesis-testing trial" as a controlled trial, occurring at any stage of development, that examines pre-stated questions.

The results summary format will be based on the International Conference on Harmonization E3 template.

References to published papers should be posted at publication, while summaries of unpublished trials should be submitted within a year of completion, PhRMA's proposal says. The one-year timeline corresponds with regulations for the submission of annual reports to FDA, PhRMA noted.

The database will also indicate studies submitted for publication; companies will post a summary of the trials if the paper has not been published within a year of the announced intent to publish.

The PhRMA database builds on efforts already launched by several member companies.

During the press conference to unveil the database, PhRMA used Lilly's Xigris trial summaries as a demonstration. Lilly is updating lillytrials.com to include results from all company-sponsored trials of marketed drugs (² Also see "LillyTrials.Com Database Will Disclose Study Results For Marketed Products" - Pink Sheet, 3 August, 2004.).

- Elizabeth Walker

PhRMA Clinical Trial Registry Will Be Launched Oct. 1

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