DATA2CARE-RD: From Clinical Trial Data to Real-World Impact in Rare Diseases

DATA2CARE-RD is a collaborative, multi-stakeholder project proposal dedicated to translating clinical trial data into tangible value for patients, care teams, and health systems in the rare disease domain, reflecting key priorities of the EU rare disease agenda leading into 2026. The project brings together patient organisations, European Reference Networks (ERNs), researchers, regulators, SMEs, and industry to advance shared approaches for the Return of Individual Participant Data (RoIPD) across the research-to-care continuum.

Building on the RoIPD-by-design framework established through the EU-funded FACILITATE project, DATA2CARE-RD shifts the focus from framework development to coordinated implementation, uptake, and stakeholder alignment. The project situates RoIPD within the regulatory and infrastructural context of the European Health Data Space (EHDS) and the clinical backbone provided by ERNs, exploring how participant-centred data return can enhance trial quality, support AI-ready and interoperable data infrastructures, and reduce inequities across Member States.

DATA2CARE-RD aims to generate scalable models, governance solutions, and real-world use cases that ensure the data generated through research meaningfully returns to those who contribute to it—supporting better care, smarter innovation, and a more coherent European rare disease ecosystem.