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	マッチド・フェーズIV試験	傾向スコアマッチング
分野	疫学	研究統計
系統	Process / pipeline	Process / pipeline
提唱年	1980s–1990s (formalized in post-marketing regulatory frameworks)	1983
提唱者	Regulatory tradition (FDA, EMA); matching methodology from Rosenbaum & Rubin (1983)	Paul Rosenbaum and Donald Rubin
種類	Observational study design	Method
原典	Strom, B. L., & Kimmel, S. E. (Eds.). (2005). Textbook of Pharmacoepidemiology. Wiley. ISBN: 978-0470029244	Rosenbaum, P. R., & Rubin, D. B. (1983). The central role of the propensity score in observational studies for causal effects. Biometrika, 70(1), 41–55.
別名	matched post-marketing surveillance study, Phase IV matched cohort study, matched pharmacoepidemiological study, post-authorization matched safety study	PSM, propensity score weighting, covariate balance
関連	5	3
概要	A Matched Phase IV study is a post-marketing observational design in which patients who received an approved drug (or intervention) are matched to comparable non-exposed patients — or patients on an alternative therapy — to evaluate real-world safety, effectiveness, or long-term outcomes. Conducted after regulatory approval, it combines the epidemiological rigour of matching with the breadth of post-authorization pharmacovigilance, generating evidence that randomized trials are rarely powered or timed to provide.	Propensity score matching (PSM) is a method for reducing confounding bias in observational studies by balancing baseline characteristics between treatment groups, simulating randomization. Developed by Rosenbaum and Rubin (1983), it estimates the probability of receiving treatment given observed covariates, then matches or weights treated and control individuals with similar treatment probabilities. Widely used in medicine, epidemiology, and policy evaluation when randomized trials are infeasible or unethical, enabling estimation of treatment effects while controlling for selection bias.