USA – FDA updates guidance on covariate treatment in clinical trials

In a revised draft guidance, the US Food and Drug Administration (FDA) has clarified how drug developers should adjust for covariates in certain clinical trials.
The revision provides “more detailed recommendations for the use of linear models for covariate adjustment and also includes recommendations for covariate adjustment using nonlinear models,” according to FDA’s Federal Register notice of the newly revised draft.
The updates to the April 2019 draft leave untouched the other recommendations for adjusting for covariates in randomized clinical trials in drug and biologics development programs. “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,” wrote FDA in its introduction to the guidance. (RELATED: FDA drafts guidance on adjusting for covariates in randomized trials, Regulatory Focus 24 April 2019)…