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

N  Engl J Med: October 24, 2013

he 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 the EMA’s policy and activities; robust and proportionate measures will be adopted to safeguard patients’ privacy, in compliance with applicable data-protection legislation.2

Pharmaceutical-industry organizations, however, have expressed concern that “one of the risks to innovation is disclosure to competitors of companies’ trade secrets and proprietary information that could allow others to `free ride’ off of the substantial investments of innovators”; they fear “degradation of incentives for companies to invest in biomedical research.”3 Read More