Adjustment for baseline covariates in clinical trials

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Current effective version

Adopted guideline

Reference numberEMA/CHMP/295050/2013
Published27/03/2015
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

Adopted guideline

 

Overview of comments

 

Draft guideline

 

Concept paper

In operation: 01/09/2015–present

 

Published: 27/03/2015

 

Published: 28/06/2013

 

Published: 29/02/2012

Superseded documentPoints to considerIn operation: 01/11/2003–31/08/2015


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