The Rare Anaemia Disorders European Epidemiological Platform (RADeep) is a European patients registry on Rare Anaemia Disorders (RADs) collecting data from both new and already existing registries across the European Union, as well as from individual Healthcare providers. Last November, the RADeep held its first Data Access Committee meeting in Vall d’Hebron. The committee has been established in order to review the content of the requests for accessing RADeep data coming from third parties (other researchers from both public and private institutions, patients associations…).

RADeep aims to map at the European level the diagnostic methods, demography, survival rate, main clinical features and treatments of RADs patients. In the future, the collected data aims at providing better care to patients affected by these rare diseases. The registry stores patients’ data in a secure way, in line with the General Data Protection Regulation (GDPR).

RADeep is led by a Consortium formed by Vall d'Hebron University Hospital and Vall d’Hebron Research Institute (VHIR) (with Maria del Mar Mañú Pereira as a principal investigator and the participation of Victoria Gutierrez, Martin Solorzano, Sara Reidel, Claire Diot-Lefebvre), Hôpital Erasme (ERASME) in Belgium (with Béatrice Gulbis and Ines Labidi) and the Cyprus Foundation for muscular dystrophy research (CING) (with Marina Kleanthous and Petros Kountouris, Stella Tamana).

RADeep, a Registry conceived in line with the European Strategy

RADeep will contribute to the European Rare Blood Disorders Platform (ENROL), the ERN-EuroBloodNet’s registry for rare blood disorders, following the European Commission’s strategy for rare diseases common to the 24 European Reference Networks (ERNs).

RADeep encourages its contributors to follow the European interoperability standards, an essential step in the context of the upcoming European Health Data Space (EHDS) which will regulate the future of Data Sharing at European level: The EHDS will start in 2025 with the goal to ensure a consistent framework for the use of individuals’ health data for research, innovation, policy-making and regulatory activities.

Thanks to its modular structure, the platform can also support specific research projects such as the Genomics For Next Generation Healthcare (GenoMed4all), the European initiative to transform the response to Haematological Diseases by seizing the power of Artificial Intelligence. The team behind GenoMed4all is working on two use cases; Myelodysplastic syndrome (MDS) and Sickle Cell Disease (SCD). The team in charge of the SCD use case is collecting clinical data through the RADeep platform, developed to include specific modules related to rare anaemia such as SCD.

The RADeep Data Access Committee

The RADeep Data Access Committee has been established in order to review the content of the requests for accessing RADeep data coming from third parties (other researchers from both public and private institutions, patients associations…).

It will also review and approve the protocol for data processing by the RADeep Consortium in order to obtain anonymized data for annual publications and for the website.

The Data Access Committee is formed by the Steering Committee of the RADeep project (RADeep’s Coordinators / Eduard J. van Beers, Haematologist / Raffaella Colombatti, Paediatrician / Paola Bianchi, Lab specialist / Dore Peerboom and Loris Brunetta, Patients' representatives), an ethical expert (Alexis Rodriguez Gallego), a Biostatistician (Sara Reidel) and data providers at national / local level who are in direct or indirect link with patients and provide data to RADeep.

In its first meeting, representatives from 10 European Member States (Belgium, Cyprus, Denmark, France, Germany, Greece, Italy, Portugal, Spain and Sweden), met in Vall d’Hebron. The Data Access Committee agreed on the principles of a Data Access Policy, as well as of a Publication Policy for RADeep.

It was also the occasion for all professionals involved, many of them administering a registry at National level, to get to better know each other, exchange best practices and plan next steps for their participation in RADeep.
The members of the Data Access Committee will meet every 2 months, starting on 8th of March 2023, virtually. In their next meeting, they will discuss the protocol for data processing by the RADeep Consortium for its first publication planned for June 2023.