Real-World Data (RWD)
Real-world data (RWD) refers to data related to patient health status and the delivery of healthcare that is collected outside the context of traditional randomized controlled trials (RCTs). It reflects routine clinical practice and is typically observational in nature.
📊 Common Sources of RWD
- Electronic health records (EHRs)
- Health insurance claims and billing data
- Patient and disease registries
- Mobile devices and wearables
- Patient and provider surveys
- Pharmacy and laboratory records
🧪 Uses of Real-World Data
- Evaluating treatment effectiveness in real-world settings
- Monitoring safety and adverse events
- Supporting regulatory decisions (e.g., FDA, EMA)
- Informing clinical guidelines and health policy
- Designing pragmatic clinical trials
⚠️ Limitations of RWD
- Potential for bias and confounding
- Missing or inconsistent data
- Limited control over data collection
- Challenges in data integration and standardization
✅ RWD vs Randomized Controlled Trials (RCTs)
| Feature | Real-World Data (RWD) | Randomized Controlled Trials (RCTs) |
|---|---|---|
| Setting | Routine clinical practice | Controlled experimental setting |
| Randomization | No | Yes |
| Generalizability | High | Often limited |
| Data quality | Variable | High |
| Bias control | Lower | Higher |
🔄 Related Concept: Real-World Evidence (RWE)
Real-world evidence (RWE) is the clinical evidence regarding the use, benefits, or risks of a medical product derived from analysis of RWD.