Real-World Data (RWD)

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.