手法を比較

	実世界エビデンス研究	コホート研究デザイン
分野	臨床研究	臨床研究
系統	Process / pipeline	Process / pipeline
提唱年	2010s-present	1970s-1980s
提唱者	FDA, EMA, and health agencies; Sherman et al. (2016) defined RWE formally	Donald Acheson, Olli Miettinen, and others in modern epidemiology
種類	Research Design	Research Design
原典	Sherman, R. E., Anderson, S. A., Dal Pan, G. J., Gray, G. W., Gross, T., Hunter, N. L., ... & Califf, R. M. (2016). Real-world evidence—what is it and what can it tell us? New England Journal of Medicine, 375(23), 2293–2297.	Miettinen, O. S. (1976). Estimability and estimation in case-referent studies. American Journal of Epidemiology, 103(2), 226–235.
別名	real-world evidence, RWE, RWD, effectiveness research	prospective study, follow-up study, longitudinal study, cohort study
関連	3	2
概要	Real-World Evidence (RWE) is clinical evidence derived from Real-World Data (RWD)—data routinely collected in clinical practice from electronic health records, insurance claims, patient registries, and other healthcare sources. Formalized by the FDA in 2016 (Sherman et al.), RWE addresses a critical gap: while randomized trials test drugs under ideal conditions, RWE evaluates how treatments actually work in diverse, real patients with comorbidities, competing medications, and varied adherence. RWE complements (not replaces) trial evidence, accelerating regulatory decision-making and supporting post-market surveillance.	A cohort study follows a group of individuals forward in time from exposure to outcome. Exposed and unexposed participants (or participants with differing exposure levels) are enrolled at baseline, characterized, and observed prospectively until the outcome occurs or the study ends. Cohort studies are fundamental to epidemiology and are the design of choice for establishing causal associations when randomized trials are infeasible or unethical.