What is real-world evidence (RWE) in healthcare?

Real-world evidence is clinical evidence generated from routinely collected health data outside the controlled environment of randomised trials. Sources include electronic health records, claims databases, disease registries, and patient-generated data from wearables. RWE can support regulatory decision-making, health technology assessment, post-market surveillance, and comparative effectiveness research. The UK has significant RWE infrastructure including CPRD, OpenSAFELY, and Hospital Episode Statistics.