Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products; Draft Guidance for Industry; Availability

摘要

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products." The draft guidance, when finalized, will represent the current thinking of FDA on adjusting for covariates in randomized clinical trials for drugs and biologics. This draft guidance revises the draft guidance "Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biologics with Continuous Outcomes" that published April 25, 2019. This revision provides more detailed recommendations for the use of linear models for covariate adjustment and also includes recommendations for covariate adjustment using nonlinear models.