26 May 2023 - This final guidance describes FDA’s current recommendations regarding adjusting for covariates in the statistical analysis of randomised clinical trials in drug development programs. 

This guidance provides recommendations for the use of covariates in the analysis of randomised, parallel group clinical trials that are applicable to both superiority trials and non-inferiority trials. The main focus of the guidance is on the use of prognostic baseline covariates to improve statistical efficiency for estimating and testing treatment effects.

Read FDA guidance document