手法を比較

	適応型第III相臨床試験	適応型第II相臨床試験
分野	疫学	疫学
系統	Process / pipeline	Process / pipeline
提唱年	1969–2019 (sequential testing roots ~1969; formal adaptive design guidance 2010–2019)	1994 (formal framework); widespread adoption 2000s–2010s
提唱者	Methodological foundations by Armitage et al. (1969); modern adaptive framework codified by FDA and ICH guidance (2010s)	Peter Bauer & Klaus Kohne (formal statistical framework, 1994); broader adaptive trial methodology developed through FDA and ICH guidance in the 2000s
種類	Interventional confirmatory clinical trial with pre-specified interim adaptations	Experimental clinical trial design
原典	International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). (2019). ICH E9(R1) Addendum on Estimands and Sensitivity Analysis in Clinical Trials to the Guideline on Statistical Principles for Clinical Trials. ICH Harmonised Guideline.	Bauer, P., & Kohne, K. (1994). Evaluation of experiments with adaptive interim analyses. Biometrics, 50(4), 1029–1041.
別名	adaptive confirmatory trial, seamless Phase II/III adaptive trial, adaptive pivotal trial, adaptive design Phase III	Adaptive Ph II trial, seamless adaptive Phase II, adaptive dose-finding trial, response-adaptive Phase II
関連	6	1
概要	An adaptive Phase III clinical trial is a confirmatory randomized controlled trial that incorporates pre-specified rules allowing modifications to the trial design — such as sample size re-estimation, dose selection, or population enrichment — based on accumulating interim data, while preserving the Type I error rate. It sits at the top of the evidence hierarchy and is used to obtain regulatory approval of new interventions.	An adaptive Phase II clinical trial is a prospective experimental design in which pre-specified rules allow the study protocol to be modified — such as dropping arms, adjusting sample size, or narrowing the patient population — based on accumulating interim data, without inflating the Type I error rate. The design is widely used in early-phase drug development to screen candidate doses or treatments efficiently while preserving statistical validity.