Clinical trials tell us what can work under ideal conditions; real-world evidence (RWE) shows what does work in everyday practice. Real-World Evidence in Psychiatry bridges the gap between controlled research and complex clinical reality by leveraging electronic health records, registries, claims, mobile sensors, and patient-reported outcomes to understand effectiveness, safety, and value. This session clarifies distinctions between efficacy and effectiveness, between randomized control and naturalistic evidence, and between data abundance and actionable insight. We explore how to design retrospective and prospective observational studies that meet regulatory, payer, and scientific standards—covering cohort definitions, confounding control, causal inference, and validation. You’ll learn how to use advanced analytics—propensity matching, instrumental variables, and target trial emulation—to approximate experimental rigor and interpret hazard ratios and effect estimates accurately. The discussion extends to pragmatic trials, hybrid implementation designs, and adaptive registries that evolve with practice.
Ethics and governance are central: privacy-preserving linkage, consent in secondary data use, and transparent analytic pipelines. Equity themes run throughout—ensuring that datasets reflect diverse populations and that findings translate into improved access and outcomes for marginalized groups. The session also demonstrates how RWE supports formulary decisions, comparative effectiveness, and quality improvement programs across systems. For clinicians and researchers, Real-World Evidence in Psychiatry, the emerging psychiatry real-world evidence conference, and methods from observational data analytics together provide a toolkit to turn clinical data into reliable, reproducible learning.