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ARTICLE ABSTRACT
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. 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 the EMA's policy and activities; robust and proportionate measures will be adopted to safeguard patients' privacy, in compliance with applicable data-protection legislation.
Link to access full article: http://www.nejm.org/doi/full/10.1056/NEJMp1310771