Online Program

Adjusting for Covariates in Randomized Clinical Trials with Continuous Outcomes (301261)

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*Daniel Rubin, Center for Drug Evaluation and Research, FDA 

Keywords: trial analysis

This presentation will discuss recommendations in the April 2019 FDA draft guidance document on covariate adjustment in randomized clinical trials. The scope of the guidance is the use of linear analysis of covariance (ANCOVA) adjustments for trials with outcomes measured on a continuous scale. The draft guidance recommends that Sponsors can use prespecified ANCOVA to adjust for baseline covariates, and notes that this can improve precision for estimating an average treatment effect and that the method is robust to model misspecification.