Drug Industry Trade Group Unveils Clinical Trials Database

The leading U.S. pharmaceutical trade association announced last week that it will launch a public database to communicate the results of clinical studies for drugs on the market.

The move by the Pharmaceutical Research & Manufacturers of America (PhRMA) comes amid mounting pressure on drug companies to provide access to clinical trial results, both positive and negative (see page 19). Companies including Eli Lilly, GlaxoSmithKline, and Merck have already announced individual initiatives in the wake of a lawsuit filed by New York Attorney General Eliot Spitzer claiming that Glaxo withheld negative information from trials of its antidepressant Paxil (paroxetine hydrochloride) in children.

PhRMA says it developed the registry as part of a three-year clinical trial reporting project. Critics say the database, which will be available on Oct. 1 at http://www.clinicalstudyresults.org, is inadequate in that it is voluntary and focused only on late-stage trial results--primarily, Phase III and postclinical studies for drugs already on the market.

Meanwhile, the International Committee of Medical Journal Editors issued a statement last week saying it will require clinical studies to be registered in a public directory as a condition for publication. ICMJE says trials must be registered at or before the onset of patient enrollment, and that this policy applies to any trial that starts enrollment after July 1, 2005.

ICMJE says registries must be free, open to all prospective registrants, electronically searchable, and managed by a not-for-profit organization. The group claims that http://www.clinicaltrials.gov, a registry operated by the National Library of Medicine, is the only one that currently meets all its criteria.