NEJM Calls for Release of Trial Data

"The international push to get drug companies to share patient-level data from their clinical trials got another shot in the arm Monday with the publishing of two papers in the New England Journal of Medicine. For years, pharmaceutical industry reformers have said that drug companies should be required to release individual patient data -- with protections to preserve privacy -- as means to ensure more transparency about the true safety and effectiveness of treatments. From Vioxx to Avandia to Infuse, they point to a growing number of controversies in which concealed clinical trial data prevented the true safety of products to become known until years after they got onto the market. At the same time, they cite research showing that up to half of all clinical trial are not published. Today, two online perspectives in the New England Journal of Medicine added to the chorus of calls for more information sharing as medicine enters the new world of 'big data.' 'The question is not whether but how these data should be broadly shared,' wrote a group of U.S. academics, consulting company officials, and a representative of the Pharmaceutical Research and Manufacturers of America. They laid out four different models for releasing data, ranging from an open access approach to one in which the trial sponsor reviews requests for data and makes decisions that can be appealed. They listed numerous potential benefits to the public, the scientific community, regulators, and even trial sponsors. Those include increased surveillance of safety and effectiveness, improving public confidence of treatments and industry, and prompting of more secondary analyses that may answer new scientific questions ... "