Real-World Evidence (RWE) is clinical evidence derived from analysis of real-world data such as EHRs, claims data, registries, wearable data, or pragmatic study sources.
RWE is used to evaluate how therapies perform in routine practice, including safety, effectiveness, adherence, and outcomes across broader and more diverse populations. It is commonly applied to support label expansions, comparative effectiveness research, and post-authorization safety evaluation. High-quality RWE depends on strong data governance, clear definitions, and methods that address bias and confounding. When generated rigorously, RWE complements clinical trial evidence and strengthens lifecycle decision-making.