Adaptive Phase II Clinical Trial
An adaptive Phase II clinical trial is a prospective experimental design in which pre-specified rules allow the study protocol to be modified — such as dropping arms, adjusting sample size, or narrowing the patient population — based on accumulating interim data, without inflating the Type I error rate. The design is widely used in early-phase drug development to screen candidate doses or treatments efficiently while preserving statistical validity.
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- Bauer, P., & Kohne, K. (1994). Evaluation of experiments with adaptive interim analyses. Biometrics, 50(4), 1029–1041. · DOI 10.2307/2533441
- Chow, S.-C., & Chang, M. (2008). Adaptive Design Methods in Clinical Trials. Chapman & Hall/CRC. · ISBN 978-1584887775
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