Real-world evidence is evidence derived from the systematic collection and analysis of real-world data concerning patient health status and the delivery of healthcare or the effects of interventions as they occur in routine clinical practice or non-controlled settings. As a research concept and methodological approach, it investigates outcomes, safety, and utilization in diverse populations under typical conditions. Key characteristics include the use of observational data from sources such as electronic health records, administrative claims databases, and registries, providing valuable insights into generalizability, long-term effects, and treatment patterns outside the controlled environment of traditional clinical trials, thereby complementing existing knowledge and informing decision-making processes.