Should There Be Public Access to Data from Clinical Trials? - Robert Wood Johnson Foundation

"For years, pharmaceutical companies have been lambasted in the media and government prosecutions for concealing information about the safety and efficacy of their products. In one particularly splashy example, GlaxoSmithKline (GSK) agreed to pay $3 billion in 2012 to settle criminal charges that it failed to report safety data concerning its antidepressant drug, Paxil, and its diabetes drug, Avandia, and engaged in unlawful marketing of these products and one other drug. One mechanism proposed for avoiding such problems is to establish a system through which participant-level data from clinical trials, stripped of identifying information about patients, would be available to the public. A potential benefit of sharing clinical trial data would be that independent scientists could re-analyze data to verify the accuracy of reports prepared by trial sponsors, which might deter sponsors from mischaracterizing or suppressing findings. Data sharing would also allow analysts both within and outside drug companies to pool data from multiple studies, creating a powerful database for exploring new questions that can’t be addressed within any given trial because the sample is too small to support such analyses.  The potential value of shared data in improving our understanding of the safety and efficacy of drugs, medical devices, and biologics has sparked considerable discussion about how to make data sharing happen. Earlier this year, the European Medicines Agency—the counterpart to the U.S. Food and Drug Administration (FDA) in the European Union—decided to start making data from trials of approved products available in 2014. This begs the question, should the FDA follow suit? ..."