Multiplicity issues in clinical trials

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Current effective version

Points to consider

Currently under revision - see below

Reference numberEMA/286914/2012
Effective from01/03/2003
KeywordsMultiplicity, hypothesis test, type I error, subgroup, responder, estimation, confidence interval
DescriptionThis document addresses the multiplicity in the clinical trials in the context of an application for marketing authorisation of a medicinal product.

Document history

Revision 1

In progress

Draft guideline




Draft concept paper

Published: 31/03/2017


Deadline for comments: 30/06/2017


Published: 30/05/2012

First version

Current version

Points to considerPublished: 19/09/2002

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