JAMA relaxes rules on clinical trial reporting of industry-sponsored trials

The editor of the Journal of the Medical Association has peeled back a controversial rule adopted three years ago to protect the integrity of clinical trials. Dr. Howard Bauchner, in an editorial posted online, wrote that requiring outside academic biostatisticians to review the findings of industry-funded clinical trials will no longer be a requirement for publication. "Advances over the past decade in standards of clinical trial reporting, enhanced understanding of the threats to validity of clinical research, increasing data transparency, and our experience support the change in policy," he wrote.

The current policy was put in place by previous editor Catherine DeAngelis in 2010 after a U.S. Senate Finance Committee report concluded that GlaxoSmithKline had withheld data from the scientific steering committee for the pivotal clinical trial testing its diabetes drug Avandia. Three years earlier, Cleveland Clinic cardiologist Steven Nissen had published an analysis of the trial suggesting the drug caused an excess of heart attacks and cardiovascular-related deaths in diabetes patients, which had not been reported by Glaxo. In a scathing commentary written at the time, DeAngelis and deputy editor Phil Fontanarosa wrote that "it is now time for all editors to require that academic researchers have full access to all trial data and that all industry-sponsored trials include independent statistical analysis and assurance."

The Food and Drug Administration eventually slapped strict controls on use of Avandia. But earlier this month, the agency called an extraordinary two-day meeting of an FDA advisory committee to review the evidence. The committee narrowly voted to relax controls on Avandia.

Follow Merrill Goozner on Twitter: @MHgoozner