REDgistry: An interoperable sustainable European Rare Eye Disease Registry

ended

ERN-EYE (represented by Hôpitaux Universitaires de Strasbourg) will transform the current Rare Eye Disease (RED) landscape in Europe, which consists of >24000 patients treated in our centres, suffering from >1000 ophthalmologic conditions, by developing an interoperable, sustainable and high-quality core patient registry for RED (i.e. REDgistry). With REDgistry, we will tackle the issues that impair the currently operational RED registries in the 13 ERN-EYE countries: lack of shared standards, absence of cross-registry interoperability, instable funding, legal uncertainty, inconsistent data quality, and absence of data sharing procedures. Hence, we aim at i) creating a harmonised high-quality GDPR-compliant registry developed in accordance to the FAIR principles (i.e. Findable, Accessible, Interoperable and Reusable), ii) entering the ad hoc cases while controlling and evaluating the data, iii) ensuring its long-term sustainability, iv) engaging the key REDgistry stakeholders. These objectives will be achieved by 1) establishing a sound governance and long-term sustainability strategy, 2) developing and implementing the IT platform, and 3) entering, cleaning and evaluating the data. REDgistry will enable the performance of epidemiology studies on RED, improve identification of currently undiagnosed RED patients, increase patient access to novel treatments and clinical trials, and enhance RED research capabilities through international cooperation, knowledge sharing and the future development of interoperable disease-specific registries. The final outputs of the REDgistry project will be an operational basic registry with a common dataset enrolled in the European Rare Disease Registry Infrastructure, a specific ophthalmic dataset, an established governance structure for the registry, a report on the preliminary epidemiology of RED in Europe, a dissemination & communication plan to raise awareness of REDgistry, and a sound economic plan to ensure its sustainability.