USA – FDA issues final guide on adaptive trial designs for drugs, biologics

The US Food and Drug Administration (FDA) last week finalized guidance on adaptive clinical trial designs for drugs and biologics.
 
The 33-page guidance, which finalizes a draft version released for comment in September 2018 and replaces an earlier guidance from 2010, sets out FDA’s recommendations on adaptive trial design principles and the information FDA will review from adaptive studies submitted as part of investigational new drug applications (INDs), new drug applications (NDAs), biologics license applications (BLAs) and supplemental applications.

While the final guidance is largely the same as the draft version, FDA says it has revised the guidance to clarify its recommendations for Bayesian adaptive designs and its expectations for the extent of prespecification required for governing adaptations to studies in addition to minor editorial changes…