FDA Releases Final Guidance on Adjusting for Covariates in Randomized Clinical Trials
The guidance describes FDA’s current recommendations regarding adjusting for covariates in statistical analysis of randomized clinical trials.
FDA released its final guidance concerning covariate adjustments in randomized clinical trials on May 30, 2023. The guidance, which applies to randomized, parallel group clinical trials for both drugs and biological products, focuses on the use of prognostic baseline covariates “to improve statistical efficacy for estimating and testing treatment effects,” according to an agency press release.
The guidance does not address use of covariates to control for confounding variables in non-randomized trials, in models to account for missing outcome data, or for analyzing longitudinal repeated measures data. Additionally, the use of Bayesian methods or machine learning methods for covariate adjustment is not addressed.
Source: FDA
PostEra Expands Pfizer Partnership with AI Lab and ADC Collaborations
January 8th 2025The AI Lab was launched almost exactly three years ago and has produced several programs so far, at least one of which achieved its first scientific stage gate 40% faster than the teams originally forecasted.
