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.
Registro de origen
Citas copiadas textualmente del registro de origen del método. No se infiere ninguna verificación a nivel de afirmación de ellas.
- 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
Afirmaciones curadas
Afirmaciones persistidas en el libro mayor de evidencia, cada una con su propia evaluación.
Esta vista no inventa una evaluación de afirmación si el libro mayor no tiene ninguna.
Métodos relacionados
Generado a partir del grafo de métodos y mostrado como relaciones sugeridas por la máquina; no se infiere ninguna afirmación de evidencia.