RWE

Real World Evidence (RWE)

USA: FDA’s Framework for Real-World Evidence Program– Clinical evidence regarding the usage and potential benefits or risks of a medical product derived from analysis of RWD (as per Framework for FDA’s Real-World Evidence Program – Glossary)

EU: imi GetReal Glossary – Real World Evidence (RWE) is the evidence derived from the analysis and/or synthesis of real-world data (RWD).  (Source: imi GetReal Glossary – 25 Oct 2016)

China: Key Considerations in Using Real-World Evidence to Support Drug Development – Clinical evidence on the use and potential benefits or risks of medical products obtained through the analysis of real-world data (as per Key Considerations in Using Real-World Evidence to Support Drug Development (Draft for Public Review) – Center for Drug Evaluation, NMPA – May, 2019)