What FDA and EMA now accept from real-world data

Real-world data is the information generated when patients are treated in ordinary practice rather than in a clinical trial: hospital and family doctor records, insurance claims, disease registries and, increasingly, readings from wearable devices. Real-world evidence is what emerges when that information is analyzed to answer a question about how a medicine performs in use.

For most of the history of drug regulation this material was used almost entirely for safety monitoring after approval. The US 21st Century Cures Act of 2016 changed the terms of the discussion by requiring the US Food and Drug Administration (FDA) to set out how such evidence could support new indications for approved products and satisfy post-approval study obligations.