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EMA’s Real-World Data Initiative Announces Its First Partners
The first group of data partners has been selected for the European Medicines Agency’s (EMA) Data Analysis and Real-World Interrogation Network (DARWIN EU). These organizations will contribute healthcare data that will be used to generate real-world evidence (RWE) to support EMA regulatory decisions and reviews.
With the selection of these organizations, the agency said it has launched the first three studies under the DARWIN EU project. One study is focused on the epidemiology of rare blood cancers, the second assesses the use of valproate, an anticonvulsant, and the third is evaluating antibiotics with antimicrobial resistance in mind.
The initial partners, which include hospitals, universities, biobanks and patient registries, are as follows:
- Auria Clinical Informatics (Finland);
- Bordeaux University Hospital (France);
- University of Oxford’s Clinical Practice Research Datalink (UK);
- University of Tartu’s Estonian Biobank (Estonia);
- Consorci Mar Parc de Salut Barcelona and Fundació Institut Hospital del Mar d’Investigacions Mèdiques’ Institut Municipal Assistència Sanitària Information System (Spain);
- Integrated Primary Care Information (The Netherlands);
- Integraal Kankercentrum Nederland’s Netherlands Cancer Registry (The Netherlands); and
- Fundación Instituto Universitario para la Investigación en Atención Primaria de Salud Jordi Gol i Gurina’s Sistema d’Informació per al Desenvolupament de la Investigació en Atenció Primària (Spain).
There are more data partners to come, EMA said, with plans for adding at least ten new partners each year. In 2023, the agency will invite interested parties to apply to participate in the initiative.

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14Apr