Adaptive trial design receives FDA's finalized guidance


Adaptive clinical trial design for drugs and biologics has received finalized guidance by the US Food and Drug Administration (FDA). The 33 paged guidance recommends on principles of adaptive trial design and the information FDA will review from adaptive studies.

The guidance replaces September 2018 guidance and earlier guidance from the year 2010. FDA further claims that while most part of the guidance remains the same as drafted guidance, it clarifies the Bayesian adaptive design and its expectation for prescription extension in context to its adaption in studies and editorial changes.