All Times EDT
This talk will discuss connections between other presentations in the session and recommendations in the May 2021 FDA revised draft guidance document on Adjustment for Covariates in Randomized Clinical Trials for Drugs and Biological Products. The guidance document extends the 2019 FDA draft guidance by providing more detailed comments, covering both linear and nonlinear models, and extending recommendations from trials with continuous outcomes to trials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 is recommended because it can improve precision and power for estimating and quantifying treatment effects, and when properly prespecified and implemented does not depend on strong model assumptions.