European Medicines Agency opens public discussion on need for active control in clinical trials

12 January 2011

The European Medicines Agency (EMA) has published a Reflection paper on the need for active control in therapeutic areas where use of placebo is deemed ethical and one or more established medicines are available on the need for active control in therapeutic areas where use of a placebo is deemed ethical and one or more established medicines are available. The reflection paper is open for public consultation until 31 March 2011.

The paper outlines a framework for the discussion and justification of the choice of control arms that is expected from an applicant in a centralised marketing authorisation application.