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Sat, Jan 08, 2005 - Page 12 News List

Drug firms promise more transparent clinical trials

CONTROVERSY Trade groups representing the world's biggest drug makers announced that information about research results would be published in a public database


Faced with pressure from lawmakers and editors of medical journals, four trade groups representing the world's biggest drug makers said on Thursday that their members planned to release more data about clinical drug trials.

In a joint statement, the groups said their member companies had committed to disclose more information about drug studies, both when the studies are started and when results are released. The groups included the Pharmaceutical Research and Manufacturers Association in Washington and organizations in Europe and Japan.

"Our companies have made a commitment to make this information available," said Caroline Loew, the US group's vice president for scientific and regulatory affairs.

The plans, which are voluntary on the companies' part, appear to reflect an effort by the drug industry to defuse the controversy over clinical trials. Over the last year, companies have been accused of highlighting positive trials while playing down or burying negative data in areas like the pediatric use of antidepressants.

The industry is confronting two immediate problems. Drug makers are facing the prospect of federal legislation that would require them to register studies in a public database and post their results in it as a condition for running a trial. Separately, several prestigious medical journals have said they would soon stop publishing the results of clinical drug trials unless certain data about those studies are disclosed in a public database when a trial starts.

Reactions to the drug industry's announcement were mixed. Some called the development a positive first step, but added that because the proposal was voluntary there were no assurances that all companies would comply with it or that they would be consistent in releasing information if they did.

The American Medical Association, the largest group that represents the nation's doctors, said it still intended to push for a federal law mandating trial disclosure. Eliot Spitzer, the attorney general of New York, who sued a drug maker, GlaxoSmithKline over its test disclosure practices, also questioned a voluntary approach.

Several individual drug companies, including Eli Lilly and GlaxoSmithKline, have already taken steps similar to those outlined in the industrywide proposal.

Under the industry plan, a company starting a drug study would list certain information about it in a public database operated by the National Library of Medicine at www.clinicaltrials.gov. However, the group said that some data would not be made public, and that the initial tests of a potential drug that examine its safety and biological activity -- studies known as Phase I trials -- would not be listed.

Under the trade group guidelines, companies would be urged to post the results of a trial within a year of a drug's approval or, in the case of a postmarketing study, a year after its completion. The results would appear in a public database run by the government, a company or a trade group.

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