Facilitating Real-World Data Discoverability and Transparency of Real-World Evidence to Support Research and Regulatory Decision-Making: The HMA-EMA Real-World Data Catalogues of Data Sources and Studies

OBJECTIVES: There is an increasing need and interest for generating and assessing real-world evidence (RWE) in healthcare and regulatory decision-making. To cater for this, the EMA launched the HMA-EMA Catalogues of real-world data (RWD) sources and studies (aka RWD Catalogues), which are centralized publicly available metadata repositories that reinforce transparency in observational research and enable researchers, regulators and pharmaceutical companies to identify and utilize RWD to investigate the use, safety, and effectiveness of medicines.

METHODS: The RWD Catalogues, which replace the ENCePP Resources Database and EUPAS Register®, were developed by drawing insights from studies and consultations with key stakeholders. They facilitate efficient searching, identification, and benchmarking of RWD sources and studies by collecting metadata elements on data sources (112 elements), studies (91 elements), institutions (15 elements), and networks (13 elements).

RESULTS: As of June 2024, the RWD Catalogues contain 220 registered data sources and 2855 studies geographically distributed across various regions in the world. The registered data sources are sources of secondary data, such as electronic health records, healthcare related administrative data sources, pharmacy dispensing records or registries. The registered studies can be non-interventional post authorization safety studies or any other RWD studies. The RWD Catalogues also support linkage between the metadata of data sources and studies thus allowing navigation between the two entities.

CONCLUSIONS: The RWD Catalogues facilitate discoverability of data sources for RWE generation when investigating a research question, allow comparison of different data sources and aid in assessing the suitability of the chosen data source in a study. By cataloguing RWD studies and making publicly available information on study design, protocol, data analysis, results; the RWD Catalogues support the design of new studies, strengthen transparency in observational research by allowing reproducibility and replicability, and enable the assessment of studies’ validity and interpretation of their results thereby reinforcing confidence in RWE.