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# Guide on Clinical Trial Adaptive Designs
- URL: https://www.fdaweb.com/guide-on-clinical-trial-adaptive-designs/
- Published: 2019-12-02T12:00:00.000Z
- Updated: 2026-09-14T15:54:54.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145615

FDA has posted a [final guidance](https://www.fda.gov/media/78495/download?ref=fdaweb.com) entitled “Adaptive Designs for Clinical Trials of Drugs and Biologics.” The document provides recommendations on the appropriate use of adaptive designs for clinical trials to provide evidence of a drug or biologic’s effectiveness and safety. It describes principles for designing, conducting, and reporting the results from an adaptive clinical trial. The guidance also advises sponsors on the types of information to submit to help FDA’s evaluation of clinical trials with adaptive designs, including Bayesian adaptive and complex trials that rely on computer simulations for their design.

FDA says the concepts outlined are also useful for early-phase or exploratory clinical trials as well as trials conducted to satisfy post-marketing commitments or requirements, it adds.