All Times EDT
Keywords: Covariate adjustment
This presentation will discuss recommendations in the May 2021 FDA revised draft guidance document on adjusting for covariates in randomized clinical trials. The guidance document extends the 2019 FDA draft guidance by providing more detailed comments, covering both linear and nonlinear models, and extending recommendations from trials with continuous outcomes to trials with binary, ordinal, or time-to-event outcomes. Covariate adjustment can improve precision and power for estimating and quantifying treatment effects, and when properly implemented does not depend on strong model assumptions. The presentation will also note several topics not covered by the guidance document for which additional research is encouraged.