Multiplicity issues in clinical trials - Scientific guideline
Table of contents
This document addresses the multiplicity in the clinical trials in the context of an application for marketing authorisation of a medicinal product.
Keywords: Multiplicity, hypothesis test, type I error, subgroup, responder, estimation, confidence interval
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Draft guideline on multiplicity issues in clinical trials (PDF/189.52 KB)
Draft: consultation closed
First published: 31/03/2017
Last updated: 31/03/2017
Consultation dates: 01/04/2017 to 30/06/2017
EMA/CHMP/44762/2017 -
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Concept paper on the need for a guideline on multiplicity issues in clinical trials (PDF/66.14 KB)
Draft: consultation closed
First published: 30/05/2012
Last updated: 30/05/2012
Consultation dates: 30/05/2012 to 30/08/2012
EMA/286914/2012