2023-11263: Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products; Guidance for Industry; Availability
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The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products." The guidance represents the current thinking of FDA on adjusting for covariates in randomized clinical trials for drugs and biological products. The guidance discusses general recommendations for performing covariate adjustment, recommendations for performing covariate adjustment using linear models, and recommendations for performing covariate adjusting using nonlinear models. The guidance is intended to facilitate covariate adjustment in the analysis of randomized clinical trials of drugs and biological products and to clarify recommendations for its use. The guidance finalizes the revised draft guidance entitled "Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products" issued on May 21, 2021.
The agency’s own summary, as published.
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