Adjustment for baseline covariates in clinical trials - Scientific guideline
Table of contents
This document provides advice on how to address important baseline covariates in designing, analysing and reporting clinical trials. It mainly focuses on confirmatory randomised trials.
Keywords: Baseline covariates, stratification, dynamic allocation, multicentre trials, baseline imbalance
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Guideline on adjustment for baseline covariates in clinical trials (PDF/146.43 KB)
Adopted
First published: 27/03/2015
Last updated: 27/03/2015
EMA/CHMP/295050/2013 -
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Overview of comments received on 'Guideline on adjustment for baseline covariates' (PDF/334.23 KB)
First published: 27/03/2015
Last updated: 27/03/2015
EMA/40143/2014 -
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Draft guideline on adjustment for baseline covariates (PDF/162.53 KB)
Draft: consultation closed
First published: 28/06/2013
Last updated: 28/06/2013
Consultation dates: 28/06/2013 to 31/12/2013
EMA/295050/2013 -
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Concept paper on the need to revise the points to consider on adjustment for baseline covariates (PDF/131.02 KB)
Draft: consultation closed
First published: 29/02/2012
Last updated: 29/02/2012
Consultation dates: 29/02/2012 to 30/05/2012
EMA/CHMP/965150/2011 -
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Points to consider on adjustment for baseline covariates (PDF/220.75 KB)
Adopted
First published: 22/05/2003
Last updated: 22/05/2003
Legal effective date: 01/11/2003
CPMP/EWP/2863/99