BACKGROUND: The HMA EMA Catalogue of real world data (RWD) sources and studies are key resources for the European regulatory and research ecosystem, supporting the discoverability, transparency, and assessment of RWD for study planning and regulatory decision making. While the Good Practice Guide provides methodological guidance on their use, its application in routine practice often requires concrete use cases. To address this gap, a new ENCePP Special Interest Group (SIG) was established to supplement existing guidance with practical applications of the Catalogue.
OBJECTIVES: The SIG aims to: (1) develop practical examples based on the use cases described in the Good Practice Guide and typical regulatory questions, while identifying additional relevant use cases to cover broader study scenarios; (2) critically test the RWD Catalogues using these examples, including mock study planning exercises supporting studies on the use, effectiveness, or safety of medicinal products; and (3) develop a consolidated report presenting practical examples, testing outcomes, and recommendations to inform future improvements of the Catalogue.
METHODS: The SIG will operate through two complementary workstreams over a 12 to 18 month mandate. The first workstream will execute mock examples reflecting the use cases described in the Good Practice Guide, documenting methodological choices, challenges, and lessons learned during the identification and selection of suitable RWD sources. The second workstream will explore potential future enhancements by testing the RWD Catalogues with hypothetical, plain language regulatory questions and assessing opportunities for improved search logic and advanced functionalities, including potential AI enabled features. The SIG will collaborate closely with the EMA to ensure all examples and outputs remain aligned with current regulatory needs.
RESULTS: The SIG will produce a comprehensive report providing step by step illustrations of how the RWD Catalogues can be used in realistic regulatory and research scenarios. Findings from the testing activities will be consolidated into a set of practical recommendations to inform future updates to the RWD Catalogue.
CONCLUSIONS: By moving from static guidance to dynamic, example based applications, this ENCePP SIG aims to enhance the usability, visibility, and impact of the HMA EMA RWD Catalogues. The resulting practical materials and recommendations will support researchers, regulators, and other stakeholders in more effectively leveraging these resources for study planning, contributing to a more robust and transparent RWD ecosystem in Europe.
Skip to main content
