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

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 availability of RWD in a timely manner. Two research questions focusing on high-priority data gaps (medical devices and secondary care prescribing) were selected as case studies to support this work. This paper summarises details of the Study-A-Thon and discusses key learnings for the UK's Medicines and Healthcare products Regulatory Agency (MHRA), UK stakeholders and international partners to reflect on when developing and implementing RWD strategies. Shortcomings of the data are discussed, such as a lack of follow-up for patients across care settings and the need to develop common data models to capture relevant information on medical product utilisation. The importance of local data and clinical expertise for success is highlighted, from encouraging better data collection at point of care through to appropriate interpretation of results. Successful delivery of results for both studies supports the view that, with further development, a UK federated data model could enhance national regulatory decision-making across the product lifecycle.