Open Clinical Trial Data for All? A View from Regulators

In this issue of PLoS Medicine, Doshi and colleagues argue that the full clinical trial reports of authorized drugs should be made publicly available to enable independent re-analysis of drugs’ benefits and risks [1]. We offer comments on their call for openness from a European Union drug regulatory perspective. For the purpose of this discussion, we consider ‘‘clinical study reports’’ to comprise not just the protocol, summary tables, and figures of (mostly) randomized controlled trials (RCTs), but the full ‘‘raw’’ data set, including data at the patient level [2]. We limit discussion to data on drugs for which the regulatory benefit-risk assessment has been completed.