Need for active control in therapeutic areas where use of placebo is deemed ethical and one or more established medicines are available - Scientific guideline

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

Keywords: Active control, placebo control

Current effective version

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

Draft: consultation closed Consultation dates: 11/01/2011 to 31/03/2011 Reference Number: EMA/759784/2010