Biomedical researchers will now have to guarantee that they--and not an industry or government funder--controlled a study in order to get the results published in some of the world's most prominent medical journals. The editors of 11 major journals today issued a joint vow to reject studies in which the sponsor was allowed to manipulate or withhold results. Researchers say the move will help discourage drug companies from trying to tweak or cover up results that don't support their financial interests.
Over the last decade, pharmaceutical companies have become the major financial sponsors of human clinical trials, which are required to win government approval of new drugs. In several cases, researchers contracted to conduct the studies have accused companies of attempting to delay, prevent, or alter publication of results that raise questions about a drug's efficacy or safety. Several journals have been embarrassed by revelations that study authors did not disclose financial ties to funders or had minimal control over papers submitted under their names.
In a bid to help researchers control how studies are organized, analyzed, and reported, the journal editors say they will now "routinely require authors to disclose details of their own and the sponsor's role in the study. ... We will not review or publish articles based on studies that are conducted under conditions that allow the sponsor to have sole control of the data or to withhold publication." The guidelines do allow sponsors to ask for time--30 to 60 days--to review a manuscript before it is submitted. Signers included the editors of the The New England Journal of Medicine, The Lancet, the Journal of the American Medical Association, and leading journals in Denmark, Canada, Australia, the Netherlands, and New Zealand.
Major drug companies say they welcome the rules. "In the interests of scientific integrity and patient safety, it is essential that academic researchers who participate in clinical trials have complete freedom to participate in and approve all aspects of a trial," Bert Spilker of the Washington, D.C.-based Pharmaceutical Research and Manufacturers of America said in a statement. And Sheldon Krimsky, a public health professor at Tufts University in Boston, Massachusetts, who has sounded the alarm about conflicts of interest in science, says, "it is a bold step forward by a small but important group of journals."