Glossary · Research & AI

Real-world data

RWD and real-world evidence (RWE)

Updated

Real-world data is health data collected outside clinical trials, from records, registries, claims and devices, and real-world evidence is what is derived from analysing it.

Regulators accept it for some decisions, and OMOP and the EHDS secondary-use rules exist largely to make it usable.

Official source

FDA: Real-World Evidence

See also

Definitions written by Anpheros from the official sources linked on each page. General information about standards and regulation, not legal or medical advice. All terms →