Knowledgeable
Definition

RWE

Real-world evidence.

Evidence derived from real-world data — registries, claims, EHRs, chart reviews — used to complement RCTs in HTA, label expansion and post-marketing commitments.

glossaryRWEregistries

Real-world evidence (RWE) is clinical evidence about the usage and benefits or risks of a medical product derived from analysis of real-world data — registries, claims, electronic health records, chart reviews. HTA bodies are increasingly willing to accept RWE, but the bar on bias control, fit-for-purpose data and pre-specification is higher than for RCTs.