手法を比較

	マッチド・フェーズIV試験	コホート研究
分野	疫学	疫学
系統	Process / pipeline	Process / pipeline
提唱年	1980s–1990s (formalized in post-marketing regulatory frameworks)	Mid-20th century (formal epidemiological design codified ~1950s)
提唱者	Regulatory tradition (FDA, EMA); matching methodology from Rosenbaum & Rubin (1983)	Doll & Hill (British Doctors Study, 1951); Snow (cholera, 1854)
種類	Observational study design	Observational longitudinal study design
原典	Strom, B. L., & Kimmel, S. E. (Eds.). (2005). Textbook of Pharmacoepidemiology. Wiley. ISBN: 978-0470029244	Rothman, K. J., Greenland, S., & Lash, T. L. (2008). Modern Epidemiology (3rd ed.). Lippincott Williams & Wilkins. ISBN: 978-0781755641
別名	matched post-marketing surveillance study, Phase IV matched cohort study, matched pharmacoepidemiological study, post-authorization matched safety study	longitudinal study, follow-up study, panel study, incidence study
関連	5	6
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.	A cohort study assembles a group of individuals who share a common starting point — typically freedom from the outcome of interest — and follows them over time to observe who develops the outcome. By comparing incidence rates between exposed and unexposed subgroups, researchers can estimate relative risk and absolute risk differences. Cohort studies are the gold-standard observational design for measuring disease incidence and establishing temporal relationships between exposure and outcome.