方法对比
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| 真实世界证据研究× | 队列研究设计× | |
|---|---|---|
| 领域 | 临床研究 | 临床研究 |
| 方法族 | Process / pipeline | Process / pipeline |
| 起源年份≠ | 2010s-present | 1970s-1980s |
| 提出者≠ | FDA, EMA, and health agencies; Sherman et al. (2016) defined RWE formally | Donald Acheson, Olli Miettinen, and others in modern epidemiology |
| 类型 | Research Design | Research Design |
| 开创性文献≠ | 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. DOI ↗ | Miettinen, O. S. (1976). Estimability and estimation in case-referent studies. American Journal of Epidemiology, 103(2), 226–235. DOI ↗ |
| 别名≠ | real-world evidence, RWE, RWD, effectiveness research | prospective study, follow-up study, longitudinal study, cohort study |
| 相关≠ | 3 | 2 |
| 摘要≠ | 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. |
| ScholarGate数据集 ↗ |
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