Medical Journal to Require More Details on Drug Trials
The British Medical Journal has announced that, beginning in January, it will no longer publish the results of clinical trials unless drug companies and researchers agree to provide detailed study data on request.
The decision by the prominent journal is meant to prod pharmaceutical companies to open up the vast quantities of data they collect in researching new drugs, very little of which is ever made public. Critics say that when results are published in medical journals, they often present a drug in the best possible light and do not permit independent researchers to vet the data.
Dr. Fiona Godlee, editor of The British Medical Journal, said in an interview Wednesday that she hoped other major journals would follow suit.
“We expect that eventually this will become the norm,” Ms. Godlee said.
Peter Doshi, a postdoctoral fellow at Johns Hopkins University School of Medicine who has publicly tussled with the drug maker Roche to release more data on the anti-influenza drug Tamiflu, applauded the announcement. “I think that’s a very powerful and important step,” he said.
Dr. Godlee said that the details of the policy were still being determined, but that any author wishing to be published in the journal would have to promise to release patient-level trial data to researchers who made a “reasonable request.” She said the journal would publicize instances in which requests were rejected.
Dr. Howard Bauchner, editor in chief of The Journal of the American Medical Association, said there were many ways to address the issue, and he believed that the industry wanted to “get this right.” He pointed to a recent announcement by the drug maker GlaxoSmithKline that it would make detailed data available.
A spokeswoman for The New England Journal of Medicine said the journal did not comment on the policies of other publications.