手法を比較

	適応的用量反応解析	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	2000s (key papers 2005–2007; ICH E4 guidance 1994 for classical dose-response)	1990 (model-based adaptive era); rule-based designs from the 1970s–1980s
提唱者	Frank Bretz, José Pinheiro and colleagues; foundational MCP-Mod framework	O'Quigley, Pepe, and Fisher (CRM); earlier rule-based 3+3 designs pre-date it
種類	Adaptive statistical design and analysis	Adaptive clinical trial design
原典	Bretz, F., Pinheiro, J. C., & Branson, M. (2005). Combining multiple comparisons and modeling techniques in dose-response studies. Biometrics, 61(3), 738-748.	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	adaptive DRA, adaptive dose-finding analysis, adaptive exposure-response analysis, adaptive D-R modeling	adaptive dose-escalation trial, adaptive dose-finding study, model-based adaptive Phase I design
関連	6	1
概要	Adaptive dose-response analysis combines pre-specified dose-response modeling with planned interim looks that allow modifications — such as dropping ineffective doses or reallocating sample size — while maintaining statistical integrity. The most widely cited framework is MCP-Mod (Multiple Comparisons and Modeling), endorsed by the EMA and FDA as a fit-for-purpose methodology for dose-finding studies in drug development.	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.