手法を比較

	実世界エビデンス研究	レジストリベース研究
分野	臨床研究	臨床研究
系統	Process / pipeline	Process / pipeline
提唱年	2010s-present	2000s-present
提唱者	FDA, EMA, and health agencies; Sherman et al. (2016) defined RWE formally	Patient registries began mid-20th century; modern registry research formalized 2000s–2010s
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.	Gini, R., Francesconi, P., Mazzaglia, G., Brignoli, G., Cricelli, C., Lapi, F., & Cricelli, A. (2020). Chronic disease prevalence from Italian administrative databases: the PREVALENTIST study. BMC Public Health, 13, 191.
別名	real-world evidence, RWE, RWD, effectiveness research	registry research, registry study, disease registry, registry-based cohort
関連	3	3
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.	Registry-based research uses systematically collected clinical data from patient registries—organized databases of patients with a specific disease or condition—to conduct observational studies. Registries began in the mid-20th century but have proliferated since the 2000s as electronic health records expanded and funding agencies recognized their value for real-world evidence generation. Registry studies provide large, diverse, representative populations without the cost of recruiting and following prospectively, enabling rapid generation of clinical evidence.