手法を比較

	ベイズ型第I相臨床試験	第I相臨床試験
分野	疫学	疫学
系統	Process / pipeline	Process / pipeline
提唱年	1990	1960s (formal regulatory framework established ~1963–1970s)
提唱者	O'Quigley, Pepe & Fisher (Continual Reassessment Method)	Regulatory and clinical pharmacology community; formalized in U.S. FDA IND regulations (1963) and ICH guidelines
種類	Adaptive Bayesian dose-finding design	Interventional clinical study 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.	Storer, B. E. (1989). Design and analysis of phase I clinical trials. Biometrics, 45(3), 925–937.
別名	Bayesian dose-finding trial, CRM trial, continual reassessment method trial, Bayesian dose-escalation study	Phase 1 trial, first-in-human study, FIH study, dose-escalation study
関連	5	6
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.	A Phase I clinical trial is the first stage of human testing for a new drug, biologic, or intervention. Its primary objective is to evaluate safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) rather than therapeutic efficacy. Small cohorts of participants — typically healthy volunteers or patients with advanced disease — receive sequentially increasing doses to identify the maximum tolerated dose (MTD) and the dose-limiting toxicities (DLTs) that define the boundary for subsequent trials.