Real-world evidence

Welcome to this lecture on real world evidence, providing an overview of the definition of real world evidence, RWE, its primary data sources, and how it differs from traditional clinical evidence. We will examine the growing importance of RWE in research, clinical decision making and regulatory processes, highlighting its strengths in capturing diverse patient experiences. The lecture will discuss both the opportunities RWE provides for generalizability and its limitations, such as potential biases and the need for robust analytic methods. Lastly, we'll look at how regulatory bodies increasingly rely on RWE and consider examples demonstrating its real world impact. We will explore what real world evidence is, its main data sources, and how it differs from traditional clinical evidence. RWE refers to clinical evidence about the use and potential benefits or risks of medical products derived from real world data collected outside conventional randomized controlled trials. The lecture will also address why RWE is increasingly influential in research, clinical practice, and regulatory decisions. Turning to data sources, real world evidence is grounded in real world data relating to patient health status and the delivery of care routinely collected from various sources. Key sources include electronic health records, insurance claims, registries, patient generated data, and data from pragmatic trials. As technology advances, these datasets expand,