方法对比

	贝叶斯II期临床试验	贝叶斯Ⅰ期临床试验
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)	1990
提出者	Peter Thall, Richard Simon, Donald Berry (key contributors)	O'Quigley, Pepe & Fisher (Continual Reassessment Method)
类型	Interventional clinical trial design	Adaptive Bayesian dose-finding 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.	O'Quigley, J., Pepe, M., & Fisher, L. (1990). Continual reassessment method: a practical design for phase 1 clinical trials in cancer. Biometrics, 46(1), 33–48.
别名	Bayesian phase 2 trial, Bayesian single-arm phase II study, Bayesian early-phase efficacy trial, Bayes phase II	Bayesian dose-finding trial, CRM trial, continual reassessment method trial, Bayesian dose-escalation study
相关	6	5
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.	A Bayesian Phase I clinical trial uses prior probability models and sequential Bayes updating to find the maximum tolerated dose (MTD) of a new agent. Unlike the traditional 3+3 rule-based escalation, the Bayesian approach revises a dose-toxicity curve continuously as each patient's outcome is observed, allowing faster convergence to the true MTD while minimising exposure of patients to unsafe or subtherapeutic doses.