手法を比較

	マッチドフェーズIII臨床試験	フェーズIII臨床試験
分野	疫学	疫学
系統	Process / pipeline	Process / pipeline
提唱年	Mid-20th century (matching in RCTs formalized ~1950s–1970s)	1962 (Kefauver-Harris Amendment formalised phased drug development)
提唱者	Fisher, R. A. (matching principles); adapted into confirmatory trial design over mid-20th century	FDA regulatory framework / ICH guidelines
種類	Controlled confirmatory clinical trial with matching	Confirmatory randomised controlled trial
原典	Rothman, K. J., Greenland, S., & Lash, T. L. (2008). Modern Epidemiology (3rd ed.). Lippincott Williams & Wilkins. ISBN: 978-0781755641	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 controlled Phase III trial, Phase III matched-pair trial, matched confirmatory trial, matched late-phase RCT	Phase 3 trial, confirmatory trial, pivotal trial, Phase III RCT
関連	5	6
概要	A matched Phase III clinical trial is a confirmatory, late-stage controlled study in which each participant assigned to the experimental treatment is paired with one or more controls who share key prognostic characteristics — such as age, disease stage, or comorbidities — before treatment allocation. By ensuring baseline comparability at the level of matched pairs, the design reduces confounding and improves statistical efficiency in settings where simple randomization alone may produce imbalanced groups or where full randomization is logistically or ethically constrained.	A Phase III clinical trial is a large-scale, confirmatory randomised controlled trial designed to establish the efficacy and safety of an intervention in the target patient population before regulatory submission. It builds on the signal identified in Phase II, tests the intervention at its proposed dose under controlled conditions, and provides the primary evidence base for marketing authorisation or guideline adoption.