Draft guideline on multiplicity issues in clinical trials

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Download document Draft guideline on multiplicity issues in clinical trials
Reference number EMA/CHMP/44762/2017
Status draft: consultation open
First published 2017-03-31
Last updated 2017-03-31
Consultation start date 2017-04-01
Consultation end date 2017-06-30
Email address for submissions multiplicity_gl@ema.europa.eu

Summary

This guideline is intended to provide guidance on how to deal with multiple comparison and control of type I error in the planning and statistical analysis of clinical trials. From the points to consider document published in 2002, aspects related with multiplicity issues in safety, drug-response studies, secondary endpoints, subgroup analysis and estimation were added or updated, and statistical terms were clarified.