FDA Draft Guidance: Adaptive Designs for Clinical Trials of Drugs and Biologics

On November 29, the Food and Drug Administration (FDA) issued a final guidance for industry entitled, “Adaptive Designs for Clinical Trials of Drugs and Biologics.” Adaptive design clinical trials allow for prospectively planned modifications to one or more aspects of the design based on accumulating data from subjects in the trial. The guidance provides information to sponsors submitting investigational new drug applications (INDs), new drug applications (NDAs), biologics licensing applications (BLAs), or supplemental applications on the appropriate use of adaptive designs for clinical trials to provide evidence of the effectiveness and safety of a drug or biologic. The guidance also advises sponsors on the types of information to submit to facilitate FDA evaluation of clinical trials with adaptive designs, including Bayesian adaptive and complex trials that rely on computer simulations for their design.

The Adaptive Design guidance is a revision of the 2018 draft guidance entitled “Adaptive Design Clinical Trials for Drugs and Biologics.” The final guidance contains revisions to the Bayesian subsection of the guidance, provides clarifications on the prespecification principle for adaptive design, and cross-references advice from the newly published draft guidance on Interacting with the FDA on Complex Innovative Trial Designs.

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