Expected Call For Advance Registration Of Drug Tests
10/19/2005 5:10:14 PM
The debate over the disclosure of clinical drug trials could reach a turning point this week, with editors of influential medical journals expected to call for fundamental changes in the way such tests are reported.
The journal editors, gatekeepers for the medical profession, are expected to begin requiring that drug trials be registered at the outset as a prerequisite for the subsequent publication of their results. Requiring such registration as a condition for reaching the journals' vast audience of doctors would make it difficult for drug companies to hide the results of unflattering tests - as some have been accused of doing.
The journal editors declined yesterday to discuss the new policy before the announcement, but the group said several months ago that it was considering such a step.
Details of the policy by the group - which includes prestigious publications like The Journal of the American Medical Association, The New England Journal of Medicine, The Lancet and The Annals of Internal Medicine - are to be presented Thursday at a House Commerce subcommittee hearing on disclosure of data from pediatric trials of antidepressants.
Meanwhile, both House and Senate Democrats say they expect to introduce legislation as early as Thursday that would require drug trials involving human subjects to be registered in a public database before the tests were allowed to proceed.
Congressional Republicans, though, have not announced any plans for such legislation. And an official of the drug industry's trade group, which yesterday announced a voluntary plan to disclose trial results, said his organization thought that legislation was not necessary.
comments powered by