This episode delves into the increasing importance of real-world evidence (RWE) in informing post-approval drug safety and effectiveness assessments. We discuss key data sources, including electronic health records (EHRs), insurance claims data, patient registries, and even social media. Analytical platforms, such as AI-driven signal detection and machine learning models, are explored.

The conversation highlights how RWE influences regulatory decisions, label updates, and the development of risk mitigation strategies. Real-world case studies from post-market surveillance programs are used to illustrate the practical impact of RWE. The episode also touches on the ethical considerations and challenges associated with using RWE, such as data privacy and ensuring the accuracy and reliability of algorithms.