Real-World Data to Real-World Evidence: Successes, Challenges, and Opportunities

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Real World Data (RWD), including electronic health records (EHR), claims, and billing data, capture detailed, longitudinal patient information, covering demographics, comorbidities, treatments, and outcomes. They have become as a vital data source reflecting real-world patient populations and clinical settings. Applying AI/ML models to RWD have generated insights and real-world evidence (RWE), such as predicting disease onset risk, modeling progression pathways, and supporting more nuanced patient stratification strategies. AI-derived RWE increasingly informs clinical and regulatory decisions.