Issue Date: December 2, 2019
Issued by: Center for Biologics Evaluation and Research
Topic(s): Biostatistics, Clinical – Medical
Status: Final
Adaptive Design Clinical Trials for Drugs and Biologics Guidance for Industry
This document provides guidance to sponsors and applicants 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 describes important 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 facilitate FDA evaluation of clinical trials with adaptive designs, including Bayesian adaptive and complex trials that rely on computer simulations for their design.
Download the Guidance Document
