EMA Releases Guideline on Covariates in Clinical Trials

Drugmakers planning to assign clinical trial participants to a separate arm of the study based on baseline monitoring must report those plans to the European Medicines Agency, including which factors — called covariates — they plan to rely on to make those assignments.

Often, these covariates are measures taken early in a trial, such as a baseline measurement, that would prompt sponsors to stratify patients into different treatment arms, according to guidance released last week.


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