Access to Patient-Level Trial Data - A Boon to Drug Developers

The European Medicines Agency aims to make patient-level data from clinical trials publicly accessible while protecting privacy; this would improve drug-development efficiency, cost-effectiveness, and comparative-effectiveness analysis and reduce duplication of effort. The provision of access to clinical trial results that include patient-level data is generating much debate. A growing chorus of transparency advocates is pushing for open access to these data, making a case on the basis of respect for patients' altruism, the need to safeguard public health, and distrust in the integrity and completeness of published trial information.(1) We at the European Medicines Agency (EMA) have been actively engaged in this debate, and the EMA has recently published a draft of a policy that would make patient-level data in its possession publicly accessible. The principle of privacy protection will inform ...