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 open
First published 03/02/2014
Last updated 03/02/2014
Consultation start date 03/02/2014
Consultation end date 31/07/2014
Email address for submissions biostatistics@ema.europa.eu

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.