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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