EMA announces first DARWIN EU^® Phase 1 data partners and opening studies

EMA names the first eight data partners selected to collaborate in Phase 1 of DARWIN EU® and details its initial three studies.

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On 23 November 2022, the European Medicines Agency (EMA) announced the first set of data partners selected to collaborate with DARWIN EU®, the Data Analysis and Real-World Interrogation Network. EMA simultaneously declared the opening three studies DARWIN EU® will address.

DARWIN EU^® is a federated network, managed by the EMA, created to provide the European Medicines Regulatory Network, which is composed of authorities from the EU member states, EMA and the European Commission, access to results of analysis of data from real-world healthcare databases across the EU to generate RWE for supporting scientific evaluations and regulatory decision making.

The first eight partners selected for Phase 1, listed below, include both public and private institutions from across Europe that have access to healthcare RWD from one or more sources such as hospitals, primary care, health insurance, biobanks, or disease-specific patient registries, representing different healthcare settings of medicines use (primary, secondary, specialist). These data partners from Spain, the Netherlands, Estonia, Finland, France and the UK will submit the results of analyses of their data to the DARWIN EU^® Coordination Centre in Rotterdam.

Data partners were selected after consultation with the DARWIN EU^® Advisory Board, according to prioritization criteria. The criteria included that sources should have continuous data collection, with at least annual data updates, and a lag time of less than 6 months in data availability for analysis and capture of health outcomes and medicines prescribing.

A crucial specification is that the data supplied must be already converted into the Observational Medical Outcomes Partnership Common Data Model, which allows analyses to be performed across sources using the same analytical code. This standardization of healthcare data format enables large-scale, pan-European analysis, with data providers collectively representing the EU population. Non-EU data sources will also be considered for inclusion if they add value to RWE analyses and enrich the results for decision making on medicines.

The number of data partners is planned to increase in the coming years, with a target of adding at least ten new data partners every year. A call for expressions of interest for potential new data partners will be launched in 2023.

With the onboarding of data partners, EMA has initiated the launch of the first three studies to be addressed by DARWIN EU^® looking at:

1. Epidemiology of rare blood cancers to inform on their prevalence in Europe
2. Drug use of valproate
3. Use of antibiotics to inform future work on antimicrobial resistance

EMA will report more details of these studies in due course, including the publication of protocols and reports in the EU Post-Authorisation Studies Register. These opening studies mark the start of a rapid ramp-up in the number of studies conducted to support regulatory decision making: the aim is that by 2025, DARWIN EU^® will deliver approximately 150 RWE studies per year.

This transformation in the structuring and scale of European healthcare RWD/RWE deployment will constitute a paradigm shift in the processes underlying medical science. The DARWIN EU^® network is intended to act as a pathfinder for the proposed European Health Data Space (EHDS), and will ultimately connect to the EHDS services, enabling the use of the EHDS in medicines regulation in Europe.

List of DARWIN EU® Data Partners onboarded in Phase I:

• Auria Clinical Informatics – Hospital District Southwest Finland (Finland)
• Bordeaux University Hospital – Centre hospitalier universitaire de Bordeaux (France)
• Clinical Practice Research Datalink (CPRD) GOLD – University of Oxford (United Kingdom)
• Estonian Biobank – University of Tartu (Estonia)
• Institut Municipal Assistència Sanitària Information System – Consorci Mar Parc de Salut Barcelona (PSMar), together with Fundació Institut Hospital del Mar d’Investigacions Mèdiques (IMIM) (Spain)
• Integrated Primary Care Information – Mieur Implementation and Exploitation B.V. (The Netherlands)
• Netherlands Cancer Registry – Integraal Kankercentrum Nederland (The Netherlands)
• Sistema d’Informació per al Desenvolupament de la Investigació en Atenció Primària – Fundación Instituto Universitario para la Investigación en Atención Primaria de Salud Jordi Gol I Gurina (IDIAPJGol) (Spain)