Patient registers and databases are key instruments for developing clinical research in the field of rare diseases, for improving patient care and health planning. They are the best way to pool data to achieve a sufficient sample size for epidemiological and/or clinical research. The registries serve as a recruitment tool for the launch of studies focusing on disease aetiology, pathogenesis, diagnosis or therapy.
The Council of the European Union recommended that, in the field of rare diseases, Member States consider supporting, at all appropriate levels, including the EU, for epidemiological purposes, registries and databases, while being aware of the existence of independent governance. To support this process and, in particular, the interoperability of data in rare disease registries, the Commission decided to create a European Platform for Rare Disease Registries (European Platform for Rare Diseases) and to develop specific standards for the interoperability of such rare disease registries (“JRC standards” developed by the Commission’s Joint Research Centre).
The main objectives of this call for projects for rural development registers for RNAs are:
- To enable the creation, improvement, connection and creation of interoperable registries covering the diseases and conditions of each RNA, linking and making visible patient cohorts at European level to follow the natural course of diseases with sufficient patient data, also by registering all individual RNA registries of RNAs on the EU platform for research and development;
- based on the previous register, develop a global approach for rare disease registries covering the respective RNAs following the standards and tools provided by the EU Rural Development Platform.
Description of the activities financed
The activities to be carried out concern the creation and development of rare disease patient registries for NRNAs and the development and quality control of existing registries.
In doing so, the following principles should be followed:
- Reinforce coordination and cooperation and develop synergies between the networks and their registries;
- Build on existing instruments and avoid duplicating similar actions or activities;
- Avoid the development of a variety of diverse and non-interoperable solutions.
10th of October, 2019