Investigation of subgroups in confirmatory clinical trials

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Current effective version

Draft guideline

Reference numberEMA/CHMP/539146/2013
Published03/02/2014
Effective from 
KeywordsSubgroup analysis, confirmatory clinical trials, randomised controlled trials, internal consistency, heterogeneity, biostatistics, assessment of clinical trials, analysis plan, exploratory analysis
DescriptionThis document provides guidance for assessors in European regulatory agencies on assessment of subgroup analyses in confirmatory clinical trials. It should also be useful to clinical trial sponsors and to assessors engaged in providing scientific advice.


Document history

First version

Current version

Draft guideline


Concept paper

Published: 03/02/2014


Published: 30/04/2010


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