Hypothesis test
Adaptive Clinical Trial Design
Adaptive clinical trial design is a flexible experimental framework, formalised by Bauer and Köhne in 1994, in which pre-specified rules allow the trial to be modified mid-course — adjusting sample size, treatment arms, or randomisation ratios — based on accumulating interim data while rigorously controlling the Type I error rate.
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Sources
- Bauer, P. & Köhne, K. (1994). Evaluation of Experiments with Adaptive Interim Analyses. Biometrics, 50(4), 1029–1041. DOI: 10.2307/2533441 ↗
- FDA (2019). Adaptive Design Clinical Trials for Drugs and Biologics — Guidance for Industry. U.S. Food and Drug Administration. link ↗