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  11. A Regulatory Perspective On A Uk Federated Data Network For Medicines And Medical Devices: Lessons From A 'study-a-thon'.
  1. Home
  3. Research Domains
  5. Information And Computing Sciences
  7. Data Management And Data Science
  9. Query Processing And Optimisation
  11. A Regulatory Perspective On A Uk Federated Data Network For Medicines And Medical Devices: Lessons From A 'study-a-thon'.

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

Helen P Booth1, John Connelly2, Daniel Dedman2

  • 1Medicines and Healthcare products Regulatory Agency, 10 South Colonnade, Canary Wharf, London, E14 4PU, UK. helen.booth@mhra.gov.uk.

Therapeutic Innovation & Regulatory Science
|August 20, 2025

View abstract on PubMed

Summary
This summary is machine-generated.

A UK distributed data network could improve regulatory decision-making using real-world data (RWD). A Study-A-Thon highlighted the need for better data access and common models to generate timely real-world evidence (RWE).

Keywords:
Data analyticsGovernment regulationMedical device regulationReal-world data

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Area of Science:

  • Health Informatics
  • Regulatory Science
  • Data Science

Background:

  • International medical regulators aim to enhance decision-making with real-world data (RWD).
  • The UK National Health Service possesses extensive population data, but faces challenges in data siloing, interoperability, and cross-setting access.
  • Mobilising a UK distributed data network is crucial for generating timely real-world evidence (RWE) for regulatory use.

Purpose of the Study:

  • To explore the potential of a UK distributed data network for generating RWE for regulatory purposes.
  • To address high-priority data gaps in medical devices and secondary care prescribing through case studies.
  • To identify key learnings for the UK's Medicines and Healthcare products Regulatory Agency (MHRA), stakeholders, and international partners regarding RWD strategies.
Real-world evidence
Routinely collected health data

Main Methods:

  • A `Study-A-Thon' event was convened in 2023.
  • Two case studies focused on medical devices and secondary care prescribing data gaps.
  • Analysis of data shortcomings and the importance of local data and clinical expertise.

Main Results:

  • The Study-A-Thon successfully generated results for both case studies, demonstrating the feasibility of the approach.
  • Identified shortcomings include lack of patient follow-up across care settings and the need for common data models for product utilization.
  • Highlighted the critical role of local data and clinical expertise in data collection and interpretation.

Conclusions:

  • A UK federated data model, with further development, can significantly enhance national regulatory decision-making throughout the product lifecycle.
  • Improved data collection at the point of care and robust interpretation are essential for successful RWE generation.
  • Collaboration and addressing data infrastructure challenges are key to leveraging RWD for regulatory purposes.