FDA Draft Guidance: ANCOVA in Randomized Clinical Trials


May 23, 2019

The Food and Drug Administration (FDA) has recently released a new draft guidance entitled, “Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biologics with Continuous Outcomes – Guidance for Industry.” This document would build on the ICH guidance for industry, “E9 Statistical Principles for Clinical Trials” by specifying the appropriate uses of analysis of covariance (ANCOVA) in randomized clinical trials. The draft guidance is open for public comment until June 24th.

Clinical trials testing investigational drugs and biologics in rare disease populations are more difficult than in more common diseases. Rare disease trials must be successful despite smaller sample sizes of patients who may have had varying disease severity, routine clinical care, and impact on quality of life prior to enrollment in the trial. Industry sponsors struggle to balance increasing diversity of trial participants while maximizing a trial’s statistical power. This new draft guidance includes recommendations for using ANCOVA to increase power without increasing statistical error.

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