RobinCar2: An R package for covariate adjustment in randomized clinical trials

Music City Center 

The importance of covariate adjustment has been increasingly recognized in drug development, driven by the recent FDA guideline. Despite the recommendations therein, the best practices and pitfalls of covariate adjustment are still not explicitly clear to statisticians working on clinical trials. This presentation introduces the development of RobinCar2, a validated R package for ROBust estimation and INference for Covariate Adjustment in Randomized clinical trials. This package has been developed jointly with ASA BIOP Covariate Adjustment SWG and the conditional and marginal effect task force within the ASA Oncology Estimand SWG. Examples will be illustrated to handle continuous and binary endpoints in randomized clinical trials.