Patient registries are organised systems that use observational methods to collect uniform data on a population defined by a particular disease, condition, or exposure, and that is followed over time. Patient registries can play an important role in monitoring the safety of medicines. (source : EMA).
In the field of rare diseases (RD), patient registries and databases constitute key instruments to develop clinical research, to improve patient care and healthcare planning. They are the only way to pool data in order to achieve a sufficient sample size for epidemiological and/or clinical research. They are vital to assess the feasibility of clinical trials, to facilitate the planning of appropriate clinical trials and to support the enrolment of patients (source: Orphanet).
The purpose of this project is to create a harmonised, high-quality GDPR-compliant registry specific for RED (so-called REDgistry) which will be integrated in the European Rare Disease Registry Infrastructure (ERDRI) in accordance to the FAIR principles and integrated in the European rare disease ecosystem.
The scattered distribution of RED patients and specialised clinicians across the EU hinders the diagnosis of these patients as well as the research and implementation of curative therapies due to the difficulty in recruiting patients for clinical trials. That’s why REDgistry aims to significantly improve the care and treatment of patients suffering from RED by collecting basic epidemiologic data with the development of a core RED registry (REDgistry) in order to:
The specific objectives of the REDgistry are achieved thanks to a structured work plan led by Hôpitaux Universitaires de Strasbourg (HUS), with the active collaboration of the ERN-EYE REDgistry consortium composed by the HCP members engaged in the project. This consortium is highly representative of the four main ERN-EYE working groups (WG) and the transversal work groups (TWG) members of the ERN-EYE. This consortium interacts with the RED community and, when necessary, the services of professional and experienced IT providers and legal advisors. Overall, this group of professionals conforms an experienced network capable of creating an interoperable and long-term sustainable RED registry connected to the ERDRI database in which the data of the existing patients at the ERN-EYE HCPs will be entered. The engagement of the affiliated HCPs and novel members is crucial for the success of the REDgistry project.
In the EU about 30 million citizens in Europe are affected by more than 6000 different rare diseases. The information about these patients is spread between hundreds of registries across Europe, at national, regional and local levels. The EU Rare Disease platform aims to provide researchers, healthcare providers, patients and policy-makers with a consistent instrument to improve knowledge, diagnosis and treatment of rare diseases. It will makes registries' data searchable at EU level and will standardise data collection and data exchange; which will increase the valid of each registry and its registration.
More info : https://eu-rd-platform.jrc.ec.europa.eu/