USA – FDA finalizes guidance on adjusting for covariates in randomized trials

The US Food and Drug Administration (FDA) on Friday released a final guidance addressing how sponsors can adjust for covariates in analyzing randomized clinical trials for drugs and biological products.

FDA states that “the main focus of the guidance is on the use of prognostic baseline covariates to improve statistical efficiency for estimating and testing treatment effects.” It covers general considerations for covariate adjustment using linear and nonlinear models.

“In many randomized controlled trials, the primary analysis used to estimate treatment effects of a new drug might not adjust for baseline covariates (through what is termed an unadjusted analysis). However, incorporating prognostic baseline covariates in the design and analysis of clinical trial data can result in a more efficient use of data to demonstrate and quantify the effects of treatment,” FDA writes in the guidance…