Intended for healthcare professionals


EMA consults public on plan to increase transparency of drug trial data

BMJ 2013; 346 doi: (Published 26 June 2013) Cite this as: BMJ 2013;346:f4124
  1. Deborah Cohen
  1. 1BMJ

The European Medicines Agency has stated its commitment to publishing clinical trial information on all drugs submitted as part of the licensing process, whether or not they are approved.

In a new draft policy document that has been distributed for consultation,1 the agency suggests that opening up its data would have many benefits for public health. Not only would it make drug development more efficient and aid the gathering of new knowledge, the European regulator said, but it would also allow better informed use of drugs and “enable third parties to verify the regulatory authority’s positions and challenge them where appropriate.”

Academics who have campaigned for access to trial data have broadly welcomed the move.

Tom Jefferson, one of the Cochrane Collaboration team that has accessed and analysed data …

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