EMA: Scientific guideline: 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:
14.01.2011
This paper describes regulatory considerations, and expectations of applicants, in discussing the
importance of a direct comparison to active control for a properly informed decision on benefit-risk.
The scope of the paper is limited to those therapeutic areas where placebo is deemed ethical and one
or more established medicines are available. The principles outlined are applicable to pivotal trials to
establish efficacy and safety, for ‘add-on’ trials as well as trials without background treatment. CHMP
has previously provided Position Statements on issues related to this topic (EMEA/17424/01 and
EMEA/119319/04). This paper supplements these documents. The paper should be read in conjunction
with relevant therapeutic area and methodological guidance documents.
SciencePharma
