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JAMA changes editorial policy on trial-data analysis

NEWS IN BRIEF — Posted July 15, 2013

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The Journal of the American Medical Association has ended its policy that required industry-sponsored clinical trial data be reviewed by an independent academic statistician. The policy was adopted in 2005 after a rash of controversies in which drugmakers hid, omitted or dishonestly manipulated unfavorable trial data, but no other major medical journals followed suit.

In a June 20 editorial, JAMA Editor-in-Chief Howard Bauchner, MD, detailed the decision. “JAMA will evaluate and consider for publication clinical trials that are analyzed by statisticians employed by or contracted by the study sponsor, without requiring independent statistical analysis by an academic biostatistician,” Dr. Bauchner wrote. “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.”

Dr. Bauchner added that the policy had “been perceived by some in academia and industry as creating barriers to publication of important trial results.” He noted that in the two years since he took over as editor-in-chief, analyses conducted by academic statisticians did not typically lead to “meaningful changes” in study results.

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