20 May 2021 - This guidance represents FDA’s current thinking on 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 factors to improve precision for estimating treatment effects rather than the use of predictive biomarkers to identify groups more likely to benefit from treatment.