Adjustment for baseline covariates in clinical trials

Current effective version

PDF iconAdopted guideline

Reference numberEMA/CHMP/295050/2013
Effective from01/09/2015
KeywordsBaseline covariates, stratification, dynamic allocation, multicentre trials, baseline imbalance
DescriptionThis document provides advice on how to address important baseline covariates in designing, analysing and reporting clinical trials. It mainly focuses on confirmatory randomised trials.

Document history

First version

Current version

PDF iconAdopted guideline

PDF iconOverview of comments

PDF iconDraft guideline

PDF iconConcept paper

In operation: 01/09/2015–present

Published: 27/03/2015

Published: 28/06/2013

Published: 29/02/2012

Superseded document PDF iconPoints to consider In operation: 01/11/2003–31/08/2015

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