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| Pragmatisk Klinisk Afprøvning× | Studier baseret på Real-World Evidence× | |
|---|---|---|
| Fagområde | Klinisk forskning | Klinisk forskning |
| Familie | Process / pipeline | Process / pipeline |
| Oprindelsesår≠ | 2009-2015 | 2010s-present |
| Ophavsperson≠ | Thorpe et al. (2009); PRECIS framework developed by international consortia | FDA, EMA, and health agencies; Sherman et al. (2016) defined RWE formally |
| Type | Research Design | Research Design |
| Oprindelig kilde≠ | 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 ↗ | 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 ↗ |
| Aliasser≠ | pragmatic trial, real-world trial, effectiveness trial, PRECIS-2 | real-world evidence, RWE, RWD, effectiveness research |
| Relaterede≠ | 4 | 3 |
| Resumé≠ | 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?' | 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. |
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