手法を比較

	多施設共同第III相臨床試験	適応的無作為化比較試験
分野	疫学	疫学
系統	Process / pipeline	Process / pipeline
提唱年	1940s–1990s (formalized through ICH harmonization ~1990s)	Late 1990s–2000s (widespread adoption post-2010)
提唱者	Codified through ICH E9 guideline (1998) and decades of regulatory practice (FDA, EMA)	Donald Berry and colleagues; formalized by FDA guidance in 2010 and 2019
種類	Confirmatory interventional study design	Experimental clinical trial design
原典	Friedman, L. M., Furberg, C. D., DeMets, D. L., Reboussin, D. M., & Granger, C. B. (2015). Fundamentals of Clinical Trials (5th ed.). Springer. ISBN: 978-3319185385	Berry, D. A. (2006). Bayesian clinical trials. Nature Reviews Drug Discovery, 5(1), 27–36.
別名	Phase III multicenter RCT, confirmatory multicenter trial, Phase 3 multicenter study, pivotal multicenter trial	adaptive RCT, adaptive trial design, response-adaptive randomization trial, adaptive clinical trial
関連	6	6
概要	A multicenter Phase III clinical trial is the definitive confirmatory study that tests whether a new intervention produces a clinically meaningful benefit over a comparator in a large, representative patient population enrolled at two or more independent research sites. It is the primary evidence basis for regulatory approval by agencies such as the FDA and EMA, combining the statistical power of large samples with the external validity gained from geographic and demographic diversity across sites.	An adaptive randomized clinical trial (adaptive RCT) is a prospective experimental study that uses pre-specified rules to modify one or more trial aspects — such as sample size, allocation ratios, or treatment arms — based on accumulating data collected during the trial itself, while maintaining statistical validity and integrity of the study.