Draft guideline on the investigation of subgroups in confirmatory clinical trials

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Download document Draft guideline on the investigation of subgroups in confirmatory clinical trials
Reference number EMA/CHMP/539146/2013
Status draft: consultation closed
First published 2014-02-03
Last updated 2014-02-03

Summary

Investigation into the effects of treatment in well-defined subsets of the trial population is an integral part of clinical trial planning, analysis and inference that follows the inspection of the primary outcome of the trial. The guideline should assist in the planning and presentation of these investigations and in the understanding of factors to be discussed when considering the credibility of findings.