RWE
Medical abbreviation · Medical Research
| Stands for | Real-world evidence |
|---|---|
| Categories | Medical |
RWE stands for Real-world evidence, a medical research abbreviation.
Clinical evidence about the use, benefits and risks of medical products derived from analysis of real-world data, such as electronic health records, claims, registries and wearable devices, rather than from traditional randomized trials. Regulators use RWE for safety monitoring and, increasingly, to support approvals and label changes.
Example: RWE from a national registry supported the label expansion to older adults.
Usage notes
The 21st Century Cures Act of 2016 directed the FDA to create a framework for using RWE, published in 2018. Confounding and data quality are the main challenges, addressed with methods such as target trial emulation. Pragmatic trials embedded in routine care blend RWE with randomization.
Related abbreviations
More medical research abbreviations
- QoL – Quality of life
- RCT – Randomized controlled trial
- ROC – Receiver operating characteristic
- RR – Relative risk
- RRR – Relative risk reduction
- RWD – Real-world data
- SD – Standard deviation
- SDV – Source data verification
- SEM – Standard error of the mean
- SIV – Site initiation visit
- SOC – Standard of care
- SPIRIT – Standard Protocol Items: Recommendations for Interventional Trials
See all 94 medical research abbreviations →
This entry is for general education and is not medical advice. Abbreviation use varies between institutions; always confirm in context.