On July 24, 2013, the Pharmaceutical Research and Manufacturers of America (PhRMA) and the European Federation of Pharmaceutical Industries and Associations (EFPIA) announced joint endorsement of the “Principles for Responsible Clinical Trial Data Sharing: Our Commitment to Patients and Researchers.”  These principles applicable to biopharmaceutical companies take effect January 1, 2014.

 The five principles outlined are (i) enhancing data sharing with researchers for legitimate scientific and medical research, including patient-level data, study-level data, and clinical study protocols; (ii) enhancing public access to clinical study information, including publishing a synopsis of the results of clinical trials and other evidence used by the U.S. Food and Drug Administration (FDA) or European Medicines Agency (EMA) to approve a new medicine after the drug receives marketing approval in the United States, European Union or member states; (iii) sharing a “factual summary” of clinical trial results to patient participants; (iv) certifying publicly that the company has adopted policies and procedures to implement sharing of clinical trial information; and (v) reaffirming commitments to publish clinical trial results regardless of outcome for, at a minimum, phase 3 clinical trials, clinical trial results of  significant medical importance, and discontinued programs for investigational medicines.

These principles complement previous PhRMA guidance, most recently updated in 2009, titled, “Principles on Conduct of Clinical Trials and Communication of Clinical Trial Results.”

Posted by Cooley

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