All Times EDT
Keywords: Covariate adjustment, randomized clinical trial, guidance
Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products Draft Guidance for Industry (May 2021) represents FDA’s current thinking on adjusting for covariates in the statistical analysis of randomized clinical trials in drug development programs. This guidance provides recommendations for the use of covariates in the analysis of randomized, parallel group clinical trials that are applicable to both superiority trials and noninferiority trials. In this presentation, we will provide a brief overview of the draft guidance and its recent update and discuss some examples of covariate adjustments in randomized clinical trials.