Real-world evidence (RWE), generated from real-world data (RWD), is pivotal in evaluating the safety and effectiveness of medical treatments beyond the controlled settings of clinical trials. Unlike randomised controlled trials (RCTs), which often involve homogeneous patient populations and limited follow-up periods, RWD utilises  diverse data sources, such as electronic health records, insurance claims, and patient registries, to assess safety and treatment outcomes in the general population. Safety data derived from RWD are critical for post-market surveillance, long-term safety monitoring, and the identification of rare or delayed adverse events. Furthermore, RWE provides insights into drug interactions and treatment effectiveness across varied demographic groups, including those under represented in clinical trials. Despite challenges related to data quality, confounding variables, and causal inference, RWE plays a crucial role in ensuring continuous safety monitoring and informing regulatory decisions post-approval.

Medical Writing. 2025;34(3):30–33.  https://doi.org/10.56012/qsvn4434