手法を比較

	マッチド第II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	1960s–1980s (formalized with Simon optimal designs, 1989)	1948 (first rigorously conducted RCT — MRC streptomycin trial)
提唱者	Gehan (1961) for Phase II designs; matching frameworks adapted from case-control methodology	Austin Bradford Hill; MRC Streptomycin Trial team
種類	Controlled clinical trial design	Interventional experimental study
原典	Gehan, E. A. (1961). The determination of the number of patients required in a preliminary and a follow-up trial of a new chemotherapeutic agent. Journal of Chronic Diseases, 13(4), 346–353.	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	matched Phase II trial, historically matched Phase II study, propensity-matched Phase II trial, externally controlled Phase II trial	RCT, randomized controlled trial, randomised controlled trial, clinical randomized trial
関連	5	6
概要	A matched Phase II clinical trial is a single-arm or small-controlled early-efficacy study in which treated patients are paired with matched controls — drawn from historical databases, registries, or concurrent external cohorts — on key prognostic variables such as age, disease stage, and performance status. This design allows preliminary efficacy assessment without a concurrent randomized arm, trading randomization for feasibility while partially controlling for confounding through the matching process.	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.