Across Pharma, Few Open Arms for Trial Data Sharing: Industry inches toward consensus on limited sharing as EMA, GSK press for open access.

"When it comes to sharing clinical trial data, at one end of the spectrum is the European Medicines Agency (EMA), which has drawn a proverbial line in the sand with its public draft of Policy 70, requiring the same open access through which it has released some two million pages of documents related to agency-approved drugs since 2010. At the other end, Sanofi CEO Christopher A. Viehbacher has drawn his own line, raising the specter that his company—and possibly others—will cut back on investment in Europe if authorities insist on such open access. Somewhere in the middle is an emerging consensus within biopharma, judging by the words of a U.S. industry group and the deeds of some companies. That consensus favors some sharing of data, though not to the degree of EMA and organizations like GlaxoSmithKline (GSK), where CEO Sir Andrew Witty has committed the company to transparency through open access to clinical trial data. Among limited data-sharing initiatives is one announced June 26 by AstraZeneca and Roche. The companies will make selected databases available for study via matched molecular pair analysis that identifies potential structural modifications companies can apply to their compounds to improve their metabolism, pharmacokinetics, or safety, without divulging confidential information about those structures ..."