Real-World Evidence Studies
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.
Quellendatensatz
Zitate wörtlich aus dem Quellendatensatz der Methode übernommen. Daraus wird keine Überprüfung auf Claim-Ebene abgeleitet.
- 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 10.1056/NEJMsb1609216
- Levitan, B., Chan, E. W., Doshi, J. A., Hines, P., Komattireddy, H., Sanchez, R., & Sheridan, S. (2018). Collaboration and competition between real-world data and clinical trials. Therapeutic Innovation & Regulatory Science, 52(2), 172–176. · URL
- FDA (2021). Strengthening Our National Strategy on Adaptive Learning Systems for Health Care Quality and Safety: Report to Congress. US Food and Drug Administration. · URL
Kuratiert Claims
Claims im Evidenz-Ledger gespeichert, jeder mit seiner eigenen Bewertung.
Diese Ansicht erfindet keine Claim-Bewertung, wenn das Ledger keine hat.
Verwandte Methoden
Generiert aus dem Methoden-Graphen und als maschinell vorgeschlagene Beziehungen angezeigt – es wird kein Evidenz-Claim abgeleitet.