Wednesday, June 30, 2004
PhRMA proposes guidelines for publication of negative clinical trial results.
Companies are currently required to publicize the results of trials only in connection with initial applications for marketing permission, but not in the post-marketing phase when drugs are tested for their efficacy in connection with other diseases or in comparison with other drugs. An editorial in today's Washington Post notes that pressure to publish negative results may backfire: "Forcing companies to publish results of all trials, as opposed to the fact of their existence, is more complicated, because a simple government regulation requiring publication of all results of all clinical trials might backfire and wind up discouraging companies from conducting any trials at all. For that reason, Congress -- not the New York courts -- needs to take up this issue again and look at incentives that might persuade companies to conduct more and better clinical trials, even if they aren't commercially advantageous. It should also consider establishing a routine, nationwide system of comparative drug testing, using university and other academic researchers. Any system that leads to the concealment or manipulation of research isn't serving doctors, patients or, in the end, even drug companies very well."