Track 35: Real-World Evidence

Overview: Real-World Evidence (RWE)

Real-World Evidence (RWE) refers to the clinical evidence derived from the analysis of Real-World Data (RWD)—information collected from sources outside of traditional clinical trials, such as electronic health records (EHRs), insurance claims, patient registries, mobile health apps, and wearable devices.

Key Sub-Topics in Real-World Evidence:

Sources of Real-World Data (EHRs, Claims, Registries) · Data Integration and Interoperability · RWE in Regulatory Submissions · RWE for Drug Safety and Effectiveness · Real-World Outcomes Research · RWE in Rare Diseases · Digital Health Data · Artificial Intelligence in RWE Analysis · Patient-Generated Health Data · RWE vs RCTs · Ethical Considerations in RWE · Health Economics and Outcomes Research (HEOR) · Post-Marketing Surveillance · RWE in Precision Medicine · Global Standards and Frameworks for RWE