European medicines regulator asks for views on access to data
24th June 2013
The European Medicines Agency has published a first draft of its policy on publication and access to clinical trial data and has asked for comments.
The EMA sets out its position on allowing scrutiny of clinical trial (CT) data: “Access to CT data in an analysable format will benefit public health in future. It will make drug development more efficient by establishing a level playing field that allows all drug developers to learn from past successes and failures, and it will enable the wider scientific community to make use of detailed and high-quality CT data to develop new knowledge in the interest of public health. The Agency also takes the view that a high degree of transparency will take regulatory decision-making one step closer to EU citizens and patients, and promote better-informed use of medicines. Independent replication of CT data analysis is a legitimate scientific and societal goal. Access to CT data will enable third parties to verify the regulatory authority’s positions and challenge them where appropriate.”
Read the EMA’s draft policy and consultation document here. The deadline for responding to the consultation is 30th September. We hope everyone who thinks increased access to data is important replies to EMA and supports the Agency in its court cases against companies trying to prevent them from releasing documents