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类别: CLINICAL
真实世界证据(RWE)
源自真实世界数据（注册登记、电子病历、理赔数据）而非随机对照试验的临床证据。FDA和EU MDR越来越多地接受RWE用于上市后研究和标签扩展。
Last reviewed 2026-08-05 · Reviewed by MedFlux Editorial Board · Editorial policy
Expanded process notes below are currently maintained in English; the short definition above is localized. See our editorial policy.
WHEN IT APPLIES
Real-world evidence (RWE) is clinical evidence derived from real-world data (RWD) such as registries, EHRs, and claims—increasingly used to support regulatory decisions and PMCF.
PROCESS / STEPS
- Define regulatory question and fitness-for-purpose of RWD sources.
- Address bias, confounding, and data quality.
- Analyze and report transparently for submissions or CER/PMCF.
- Combine with traditional trials when needed.
EXAMPLES
- Postmarket label expansions sometimes leverage RWE packages when RCTs are impractical.
RELATED GUIDES & TOOLS
SOURCES
Track regulatory signals related to 真实世界证据(RWE) across 27 authorities in real time.
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