What the FDA’s Final Guidance on Covariates Means for Fighting the Placebo Response in RCTs: Our Article Published in ACRP Journal
The recently released final guidance by the U.S. Food & Drug Administration (FDA) on “Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products” introduces a new framework that is poised to transform the way statistical analyses are conducted in RCTs.