Adaptive design« Back to Glossary Index
Adaptive design allows a clinical trial to adjust its design in response to information gained throughout the clinical trial. In adaptive design, patient outcomes are measured and analyzed at specific points throughout the trial. Changes to the study design may be implemented based on these observations. Types of modifications include targeting a specific subpopulation of patients, ending a trial early, adjusting sample size, reducing the number of trial arms, changing study endpoints, and modifying dose and/or treatment duration. Adaptive design may provide a more ethical, efficient, and informative alternative to traditional, fixed-design, randomized controlled trials.
U.S. Food and Drug Administration (FDA): Adaptive Design Clinical Trials for Drugs and Biologics Guidance for Industry
Adaptive design clinical trials: a review of the literature and ClinicalTrials.gov [2018 published article]
Adaptive designs in clinical trials: why use them, and how to run and report them [2018 published article]