Presentation (CTI)

OBJECTIVES: Preregistration of real-world data (RWD) studies supports transparency, reproducibility, and trust in real-world evidence (RWE). RWE assessment requires understanding of study design, data sources used, analytical methods, and findings generated. This analysis describes information captured in study registrations in the HMA-EMA Catalogues of RWD sources and studies that support this assessment.
METHODS: We conducted a descriptive analysis of study records available in the Catalogues as of 15 June 2026 by study status, registration type, geographical scope, and protocol availability. Among finalised studies, we assessed availability of results information and study reports. For records published after the Catalogues’ launch, we assessed availability of data source information, mapping to a common data model (CDM), and whether information related to procedures of data characterisation, extraction, and results generation was provided. We reported additional Catalogue resources that support data source discovery and study planning.
RESULTS: The Catalogue included 3,367 study records: 452 planned, 937 ongoing, 1,953 finalised, and 25 discontinued or cancelled. Most registrations were voluntary (95%) and included at least one European country (76%). Overall, 2,022 studies (60%) included a protocol. Among finalised studies, 1,167 (60%) included results information and 366 (19%) study reports. Among 609 records published after the Catalogues’ launch, 401 (66%) included data source information. In this subset, 149 (25%) reported mapping to a CDM and 142 (23%) reported that data source characterisation had been conducted. Detailed information on procedures of data characterisation, extraction, or results generation was available for 32 records (5%). The Catalogues included 283 data sources, 838 institutions, and 189 network records.
CONCLUSIONS: RWD study records are driven mainly by voluntary submissions. Protocols, results, and data source information are more often available compared to other study resources. Increasing the availability of study documents and linkage to Catalogue data sources would improve utility for evidence interpretation, reproducibility, and future study planning.