RWD, RWE, registries, claims data, and their use in safety evaluation (EMA RWE guidance, FDA 2026).
21 terms
Data relating to patient health and/or delivery of care routinely collected from sources such as electronic health records, claims, registries, or wearables (FDA RWE Framework).
Clinical evidence about use and benefits/risks of a medicine derived from analysis of RWD (FDA). Used to support regulatory decisions including post-market safety.
Use of real-world data (e.g., claims, EHR, registries) to evaluate or validate safety signals, estimate rates, or assess confounders.
Assessment of whether a given RWD source is adequate for the intended PV or safety question (completeness, accuracy, relevance, timeliness).