手法を比較

	ベイズ型第I相臨床試験	適応型第I相臨床試験
分野	疫学	疫学
系統	Process / pipeline	Process / pipeline
提唱年	1990	1990 (model-based adaptive era); rule-based designs from the 1970s–1980s
提唱者	O'Quigley, Pepe & Fisher (Continual Reassessment Method)	O'Quigley, Pepe, and Fisher (CRM); earlier rule-based 3+3 designs pre-date it
種類	Adaptive Bayesian dose-finding design	Adaptive clinical trial design
原典	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.	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.
別名	Bayesian dose-finding trial, CRM trial, continual reassessment method trial, Bayesian dose-escalation study	adaptive dose-escalation trial, adaptive dose-finding study, model-based adaptive Phase I design
関連	5	1
概要	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.	An adaptive Phase I clinical trial is a first-in-human or early-phase dose-finding study that continuously updates the recommended dose after each patient cohort using a prespecified statistical model, rather than following a fixed rule. The goal is to identify the maximum tolerated dose (MTD) or the recommended Phase II dose (RP2D) efficiently while minimising exposure of participants to sub-therapeutic or toxic doses. Adaptive designs — most notably the Continual Reassessment Method (CRM) — replace or augment traditional rule-based designs such as the 3+3 schema.