手法を比較

	多施設共同第III相臨床試験	ランダム化比較試験 (RCT)
分野	疫学	疫学
系統	Process / pipeline	Process / pipeline
提唱年	1940s–1990s (formalized through ICH harmonization ~1990s)	1948 (first rigorously conducted RCT — MRC streptomycin trial)
提唱者	Codified through ICH E9 guideline (1998) and decades of regulatory practice (FDA, EMA)	Austin Bradford Hill; MRC Streptomycin Trial team
種類	Confirmatory interventional study design	Interventional experimental study
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	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
別名	Phase III multicenter RCT, confirmatory multicenter trial, Phase 3 multicenter study, pivotal multicenter trial	RCT, randomized controlled trial, randomised controlled trial, clinical randomized 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.	A randomized clinical trial (RCT) is an experimental study design in which participants are randomly assigned to an intervention group or a control group, then followed prospectively to compare outcomes. Random allocation is the defining feature: it distributes known and unknown confounders across groups by chance, making the RCT the strongest individual study design for establishing causal efficacy of a treatment or intervention under controlled conditions.