Randomised controlled trials are the gold standard for evaluating the efficacy of medical interventions, offering robust evidence through controlled designs that minimise bias. However, their generalisability to diverse patient populations is typically limited. Real-world evidence (RWE), derived from real-world data, such as registries, electronic health records, claims databases, patient networks, social media, and wearables, has emerged as a vital complement to randomised controlled trials, addressing questions of effectiveness, safety, and cost-effectiveness across a medicinal product’s lifecycle. In this article, we highlight the expanding role of RWE, from early development to post-launch activities, with examples from sponsor’s RWE studies.

Medical Writing. 2025;34(3):54–58. https://doi.org/10.56012/rcwk9212