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| 実世界エビデンス研究× | 実践的臨床試験× | |
|---|---|---|
| 分野 | 臨床研究 | 臨床研究 |
| 系統 | Process / pipeline | Process / pipeline |
| 提唱年≠ | 2010s-present | 2009-2015 |
| 提唱者≠ | FDA, EMA, and health agencies; Sherman et al. (2016) defined RWE formally | Thorpe et al. (2009); PRECIS framework developed by international consortia |
| 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. DOI ↗ | Thorpe, K. E., Zwarenstein, M., Oxman, A. D., Treweek, S., Furberg, C. D., Altman, D. G., ... & Tugwell, P. (2009). A pragmatic-explanatory continuum indicator summary (PRECIS): a tool to help trial designers. CMAJ, 180(10), E47–E57. DOI ↗ |
| 別名≠ | real-world evidence, RWE, RWD, effectiveness research | pragmatic trial, real-world trial, effectiveness trial, PRECIS-2 |
| 関連≠ | 3 | 4 |
| 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 pragmatic trial is designed to evaluate the real-world effectiveness of an intervention in typical clinical settings with diverse, representative patients, minimal exclusion criteria, and clinically relevant outcomes. Developed by Thorpe and colleagues (2009) and formalized via the PRECIS-2 framework (2015), pragmatic trials bridge the gap between explanatory efficacy trials (conducted in controlled research settings) and implementation science, answering the question 'Does this work in actual clinical practice?' rather than 'Can this work under ideal conditions?' |
| ScholarGateデータセット ↗ |
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