手法を比較

	マッチド第II相臨床試験	マッチドコホート研究
分野	疫学	疫学
系統	Process / pipeline	Process / pipeline
提唱年	1960s–1980s (formalized with Simon optimal designs, 1989)	Mid-20th century; propensity-score variant 1983
提唱者	Gehan (1961) for Phase II designs; matching frameworks adapted from case-control methodology	Established practice; propensity-score matching formalized by Rosenbaum & Rubin (1983)
種類	Controlled clinical trial design	Observational analytic study design
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.	Rothman, K. J., Greenland, S., & Lash, T. L. (2008). Modern Epidemiology (3rd ed.). Lippincott Williams & Wilkins. ISBN: 978-0781755641
別名	matched Phase II trial, historically matched Phase II study, propensity-matched Phase II trial, externally controlled Phase II trial	matched follow-up study, paired cohort study, propensity-matched cohort, matched prospective study
関連	5	5
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 matched cohort study is an observational design in which each exposed participant is paired with one or more unexposed counterparts who share key characteristics — such as age, sex, or comorbidity status — before both groups are followed forward in time to compare incident outcomes. Matching controls for measured confounders at the design stage, reducing bias that would otherwise require statistical adjustment alone.