The Coordination Centre will develop and manage a network of real-world healthcare data sources across the EU standardised to the Observational Medical Outcomes Partnership (OMOP) Common Data Model (CDM) and will conduct scientific studies requested by medicines regulators and, at a later stage, requested by other stakeholders.
The vision of DARWIN EU® is to give EMA and national competent authorities in EU Member States access to valid and trustworthy real-world evidence, for example on diseases, patient populations, and the use, safety and effectiveness of medicines, including vaccines, throughout the lifecycle of a medicinal product.
Future healthcare crises
By supporting decision-making on the development, authorisation and surveillance of medicines, a wide range of stakeholders will benefit, from patients and healthcare professionals to health technology assessment bodies and the pharmaceutical industry. Additionally, DARWIN EU® will provide an invaluable resource to prepare for and respond to future healthcare crises and pandemics.
For example, the availability of timely and reliable real-world evidence can lead to innovative medicines becoming more quickly available to patients. Better evidence also supports more informed regulatory decision-making on the safe and effective use by patients of medicines on the market.
The contract was awarded to Erasmus MC under the leadership of Professor Peter Rijnbeek, Chair of the Department of Medical Informatics, following a call for tender for a service provider published in June 2021. The Coordination Centre will be established and operated together with the subcontractors University of Oxford, Synapse, IQVIA, Odysseus Data Services, and The Hyve.
Erasmus MC and its subcontractors will set up the necessary infrastructure of the Coordination Centre and establish the required business services. DARWIN EU® will be able to leverage the extensive work done within the European Health Data and Evidence Network (EHDEN) project funded by the Innovative Medicines Initiative (IMI), and the Observational Health Data Sciences and Informatics (OHDSI) community.
A multi-stakeholder information webinar to introduce the establishment of DARWIN EU, highlight opportunities for collaboration and answer questions will be organised by EMA on 24 February 2022. Further information will be made available on the DARWIN EU ® webpage.