Draft guideline on adjustment for baseline covariates

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Download document Draft guideline on adjustment for baseline covariates
Reference number EMA/295050/2013
Status draft: consultation open
First published 28/06/2013
Last updated 28/06/2013
Consultation start date 28/06/2013
Consultation end date 31/12/2013
Email address for submissions biostatistics@ema.europa.eu

Summary

Baseline covariates impact the outcome in many clinical trials. Although baseline adjustment is not always necessary, in case of a strong or moderate association between a baseline covariate(s) and the primary outcome measure, adjustment for such covariate(s) generally improves the efficiency of the analysis. Besides editorial changes the major change with this revision of the guideline relates to the use of dynamic allocation methods.