Data Network

A strategic priority for DARWIN EU® is to expand the scope of the network for generation of new evidence supporting the benefit-risk decision making by the EU Regulatory Network. In collaboration with EMA and the Scientific Panel, the Coordination Centre shall seek to identify new data partners and data sources and integrate new infrastructure and techniques into the network of data partners.  

The data partners enable DARWIN EU to use their data in its scientific studies, and provide analysis results to the DARWIN EU Coordination Centre, in accordance with data protection rules. They can be part of the data network directly or through a Data Permit Authority, as shown in the figure below.

DARWIN EU is expected to bring on board a minimum of ten data sources every year.

The following requirements are defined for candidate data sources:

  • Data sources collecting health data routinely and representative of the different types of real-world data in terms of data elements, setting (primary & secondary care), population and origin (e.g. electronic health care records, claims)
  • Data sources which collectively provide a broad geographical coverage
  • Data sources containing patient-level data with a unique patient identifier linking all records relating to a given patient
  • Medicines prescribed or dispensed identifiable with quantities (e.g. doses, package size) and dates allowing to calculate cumulative doses and duration of use and linked to individual but unidentifiable patients
  • Clinical events formally coded, with accurate dates and linked to individual but unidentifiable patients
  • Data already converted or planned to be converted into a common data model

In November 2022, DARWIN EU completed the onboarding of the first set of data partners with access to real-world healthcare data from sources such as hospitals, primary care, health insurance, registries and biobanks.

Data Sources were selected after consultation with the DARWIN EU Advisory Board and following the prioritisation criteria below:

  • Continuous data collection (at least annual data updates)
  • A lag time of less than six months in data availability for analysis and capture of health outcomes and medicines prescribing or dispensing
  • Data converted into the Observational Medical Outcomes Partnership (OMOP) common data model

The current list of Data Sources: 

Data Partner Data Source Country
1 Centre hospitalier universitaire de Bordeaux Bordeaux University Hospital France
2 University of Oxford Clinical Practice Research Datalink (CPRD) GOLD  United Kingdom
3 University of Tartu Estonian BioBank (EBB) Estonia
4 Consorci Mar Parc de Salut Barcelona (PSMar), together with Fundació Institut Hospital del Mar d’Investigacions Mèdiques (IMIM) Institut Municipal Assistència Sanitària Information System (IMASIS) Spain
5 Mieur Implementation and Exploitation B.V Integrated Primary Care Information (IPCI)  The Netherlands
6 IQVIA Solutions BV IQVIA Disease Analyzer (DA) Germany  Germany
7 IQVIA Solutions BV IQVIA Longitudinal Patient Database (LPD) Belgium  Belgium
8 Integraal Kankercentrum Nederland Netherlands Cancer Registry (NCR)  The Netherlands
9 Fundación Instituto Universitario para la Investigación en Atención Primaria de Salud Jordi Gol i Gurina (IDIAPJGol) Sistema d’Informació per al Desenvolupament de la Investigació en Atenció Primària (SIDIAP) Spain
10 Finnish Institute for Health and Welfare (Finland) Consortium of the Finnish OMOP data partners (FinOMOP) Finland
11 Clinical Academic Center Egas Moniz Health Alliance Egas Moniz Health Alliance DataBase (EMDB) Portugal
12 Croatian Institute of Public Health National Public Health Information System (NAJS) Croatia
13 University of Oslo Norwegian Linked Health Registry (NLHR) Norway
14 Semmelweis University Semmelweis University Clinical Data (SUCD) Hungary
15 Health Data Hub Système National des Données de Santé (SNDS) France
16 University of Oxford UK BioBank (UKBB) United Kingdom
17 Unidade Local de Saúde de Matosinhos Unidade Local de Saúde de Matosinhos Realtime Database (ULSM-RT)  Portugal
18 FISABIO Valencia Health System Integrated Database (VID) Spain
19 Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) Base de Datos para la Investigación Farmacoepidemiológica en el Ámbito Público (BIFAP) Spain
20 Danish Health Data Registries Danish Health Data Registries (*Onboarding in progress) Denmark
 

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