Covariate Adjustment in Randomized Trials: Recent Development in Theory, Method and Software

Oregon Convention Center 

Covariate adjustment can improve precision in analyzing randomized clinical trials. In May 2023, FDA issued a final guidance for industry for covariate adjustment in randomized trials for drugs and biological products. However, there are still many challenges and open questions in implementing covariate adjustment in practice, e.g. missing data, stratified experiment, cluster randomized trials, and lack of software. In this talk, we review several important recent advancements in the theory, methods, and software that address these barriers.