方法对比

	贝叶斯II期临床试验	自适应随机临床试验
领域	流行病学	流行病学
方法族	Process / pipeline	Process / pipeline
起源年份	1990s (Thall & Simon 1994; Berry 1985–2006)	Late 1990s–2000s (widespread adoption post-2010)
提出者	Peter Thall, Richard Simon, Donald Berry (key contributors)	Donald Berry and colleagues; formalized by FDA guidance in 2010 and 2019
类型	Interventional clinical trial design	Experimental clinical trial design
开创性文献	Thall, P. F., & Simon, R. (1994). Practical Bayesian guidelines for phase IIB clinical trials. Biometrics, 50(2), 337–349.	Berry, D. A. (2006). Bayesian clinical trials. Nature Reviews Drug Discovery, 5(1), 27–36.
别名	Bayesian phase 2 trial, Bayesian single-arm phase II study, Bayesian early-phase efficacy trial, Bayes phase II	adaptive RCT, adaptive trial design, response-adaptive randomization trial, adaptive clinical trial
相关	6	6
摘要	A Bayesian Phase II clinical trial applies Bayesian statistical inference to the standard Phase II objective of evaluating whether an experimental treatment shows sufficient early-phase efficacy to justify progression to a Phase III trial. By combining prior information with accumulating trial data, it enables principled interim monitoring, flexible stopping rules, and updated probability statements about treatment effect — all without the multiple-testing penalties that burden frequentist sequential designs.	An adaptive randomized clinical trial (adaptive RCT) is a prospective experimental study that uses pre-specified rules to modify one or more trial aspects — such as sample size, allocation ratios, or treatment arms — based on accumulating data collected during the trial itself, while maintaining statistical validity and integrity of the study.