Pharma Industry To Publish Clinical Trial Results

Leading pharmaceutical industry groups announced today adoption of an agreement to submit for journal publication all results of late-stage clinical trials whether the outcomes were positive or negative. The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) today approved a “Joint Industry Position of the Publication of Clinical Trial Results in the Scientific Literature.” It previously was approved by the European Federation of Pharmaceutical Industries and Associations (EFPIA), the Japanese Pharmaceutical Manufacturers Association (JPMA) and the Pharmaceutical Research and Manufacturers of America (PhRMA). The position is an extension of the existing requirement of members to disclose the trials they are undertaking in online registries. It now requires members to seek journal publication of the result of phase III clinical trials and other trials of significant medical importance. The timeframe for this submission is ideally within 12 months, and no more than 18 months, after approval of the product or decision to discontinue the trial. In addition, the position, available here, provides guidelines for the enhancement of transparency regarding the authorship of manuscripts. Online registration details and summary results of member’s clinical trials can be found here.

By Emma Broster for Intellectual Property Watch