(155) The Data Analysis and Real-World Interrogation Network (DARWIN EU®): A Federated Network of Data Sources and Services in the European Union

Publication Number: 1200

Background: The European Union (EU) has a rich and diverse healthcare data landscape bringing opportunities for real-world studies performed in populations with different health care systems, drug exposure and clinical practices. The 2020 joint Heads of Medicines Agencies/European Medicines Agency (EMA) Big Data Task Force report recommended to develop DARWIN EU®, which was reflected in the European Medicines Regulatory Network strategy to 2025. In February 2022, the European Medicines Agency appointed through an open tender the Erasmus University Medical Centre Rotterdam (EMC) as the Coordination Centre of DARWIN EU®, a federated network of services to support EMA and national competent authorities with evidence on diseases, patient populations and performance of medicines.

Objectives: To describe the set-up, benefits and methods of DARWIN EU® established and rolled out in the EU from 2022.

Methods: With EMA’s oversight, the EMC will onboard within 5 years at least 40 partners using the OMOP common data model (CDM), characterize data sources, implement data quality standards and use validated standardised analytics across the network to perform studies. EMC will leverage data sources with existing OMOP instances (e.g. previously supported by the European Health Data and Evidence Network, www.ehden.org) or planning to map their data to OMOP. EHDEN will open more calls for data partners in 2022.

Results: DARWIN EU® plans to deliver an increasing number of studies over the years. By 2025, it will deliver annually at least 60 routine repeated analyses replicating a generic protocol, 60 off-the-shelf studies adapting a generic protocol to a specific research question, 24 complex studies with a specific study design and 1 very complex study that may require primary data collection or validation study. By supporting healthcare data analysis with full compliance to data protection, DARWIN EU® will contribute to developments of methods and data sources and act as pathfinder for the European Health Data Space (EHDS).

Conclusions: The large volume and quality of evidence provided by DARWIN EU® will support better and faster decision-making on the benefits and risks of medicinal products. At a later stage, it will address data needs from other EU Agencies, Health Technology Assessment bodies, payers and other stakeholders.