INDUSTRY GROUP CALLS FOR MEMBERS TO PUBLISH ALL TRIAL RESULTS

The industry's leading trade group has released a proposal calling on its members to publicly disclose the results of all clinical trial research.

Under PhRMA's plan, member companies would post results from all hypothesis-testing clinical trials on the National Library of Medicine's website, http://www.ClinicalTrials.gov (http://www.ClinicalTrials.gov). Drug firms currently only publish the results of studies investigating life-threatening diseases.

PhRMA's Clinical Trial Registry Proposal states that member firms would commit to the registration of all company-sponsored hypothesis-testing (nonexploratory) clinical trials conducted on drugs and biologics marketed in the U.S., or intended for marketing in the U.S., regardless of the disease studied or the location of the trial.

Beginning July 1, PhRMA member companies will post, on a voluntary basis, information regarding all new hypothesis-testing clinical trials. All ongoing hypothesis-testing trials are to be posted by Sept. 13.

PhRMA said exploratory studies would not be registered in the government database unless the results are medically important. The group explained that exploratory studies are often highly proprietary and reflect certain unique endpoint measures.

In addition, PhRMA said it would expand its own clinical trial registry (http://www.ClinicalStudyResults.org (http://www.ClinicalStudyResults.org)) to include a unique trial identifier that is already used on the government website to cross-reference studies in various databases and publications. Trial sponsors will indicate on the government site if a study listed in that registry also has results posted on PhRMA's site.