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.
원본 기록
방법의 원본 기록에서 그대로 복사된 인용입니다. 이로부터 수준별 검증이 추론되지 않습니다.
- 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
큐레이션된 주장
각각 자체 평가와 함께 증거 원장에 유지된 주장입니다.
원장에 주장 평가가 없는 경우 이 보기에서는 주장 평가를 만들지 않습니다.
관련 방법
방법 그래프에서 생성되었으며 기계가 제안한 관계로 표시됩니다 — 증거 주장이 추론되지 않습니다.