手法を比較

	適応型第I相臨床試験	適応的臨床試験デザイン
分野	疫学	実験計画法
系統	Process / pipeline	Hypothesis test
提唱年	1990 (model-based adaptive era); rule-based designs from the 1970s–1980s	1994
提唱者	O'Quigley, Pepe, and Fisher (CRM); earlier rule-based 3+3 designs pre-date it	Bauer & Köhne
種類	Adaptive clinical trial design	Adaptive hypothesis test with interim analyses
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.	Bauer, P. & Köhne, K. (1994). Evaluation of Experiments with Adaptive Interim Analyses. Biometrics, 50(4), 1029–1041.
別名	adaptive dose-escalation trial, adaptive dose-finding study, model-based adaptive Phase I design	adaptive design, group sequential design, sample size re-estimation, platform trial
関連	1	3
概要	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.	Adaptive clinical trial design is a flexible experimental framework, formalised by Bauer and Köhne in 1994, in which pre-specified rules allow the trial to be modified mid-course — adjusting sample size, treatment arms, or randomisation ratios — based on accumulating interim data while rigorously controlling the Type I error rate.