A Regulatory Perspective on a UK Federated Data Network for Medicines and Medical Devices: Lessons from a 'Study-A-Thon'.

Abstract

Internationally, medical regulators are seeking to make better use of real-world data (RWD) to support their decision making. While the UK National Health Service collects population-wide cradle-to-grave data, challenges remain around siloing, interoperability and access to data across different care settings. In 2023, a `Study-A-Thon' was held to explore how mobilisation of a UK distributed data network might be used to generate real-world evidence (RWE) for regulatory purposes by increasing av