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

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11/01/2011

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

The European Medicines Agency (EMA) has published a reflection paper 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.

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Comments should be sent to lena.christiansen@ema.europa.eu using the template.