This article introduces the Data Analysis and Real-World Interrogation Network (DARWIN EU®), an EU-wide network of high-quality observational healthcare databases to facilitate decision making by the European Medicines Agency (EMA) and national regulatory bodies. Besides the history and organization of DARWIN EU®, we will highlight The Hyve’s contribution to the data quality assurance process.
Real-world evidence in medicines assessment
The DARWIN EU® was established in February 2022 by the EMA in collaboration with the European Medicines Regulatory Network, following the establishment of ten recommendations of the joint Big Data Task Force of EMA and Heads of Medicines Agency (HMA).
Both bodies emphasize the enormous potential of real-world evidence to better understand use, safety, and effectiveness of medicines and vaccines and they highly recommend leveraging this kind of data for regulatory decision making as well as to support crisis preparedness and response. Also, the use of big data in evidence generation will support innovation and public health.
European Medicines Regulatory Network (EMRN) strategy to 2025
By 2025 the use of Real-World Evidence will have been enabled and the value will have been established across the spectrum of regulatory use cases.
Access to valid and trustworthy real-world evidence across the EU
DARWIN EU® is a federated network of high-quality healthcare databases across Europe, that provides expertise and services to support regulatory decision-making throughout the lifecycle of a medicinal product. The data will be processed locally by the data partners and only aggregated results will be shared.
DARWIN EU® will deliver reliable real-world evidence fast by:
- Establishing a catalogue of healthcare databases across Europe in which the number of entries will evolve in the coming months and years
- Providing high-quality observational data about medicine use, safety and effectiveness as well as for studies about diseases and patient populations
- Addressing specific questions through a broad array of non-interventional studies through standardized analysis
The first pilot studies will be executed in 2022. The number of studies commissioned by the EMA or by national authorities will significantly increase in the coming years.
Erasmus MC Rotterdam appointed as Coordination Centre
EMA is working with Erasmus University Medical Center Rotterdam to establish the DARWIN EU® Coordination Centre (CC). The contract was awarded to Erasmus University Medical Center Rotterdam following a call for tender for a service provider published in June 2021.
Key responsibilities of the CC include ensuring data interoperability (in structure and semantics using the OMOP Common Data Model), maintenance and expansion of the network of data partners, development and set up of a technology stack as well as design and implementation of standardized analytics. Erasmus University Medical Center together with its subcontractors − University of Oxford, Synapse, IQVIA, The Hyve and Odysseus − can leverage decades of experience in the field of real-world data and in-depth expertise in running observational studies on high-quality interoperable data in the OMOP common data model.
Operating a high-quality data network
An essential prerequisite for the DARWIN EU® federated network is the strong engagement with data partners that can provide routinely collected observational healthcare data that represents the full spectrum of real-world data. This includes data collected in different settings (primary and secondary care), different populations, and different source systems such as electronic health records (EHR) or claims data. Broad geographical coverage across Europe as well as patient records with unique identifiers will also be essential. In the coming years, the number of databases connected to the network is expected to increase by 10 each year.
A strong advantage of the DARWIN EU® initiative is that it does not have to start from scratch, but that it can build on numerous existing and highly successful European initiatives and public-private partnerships. A prime example is the IMI EHDEN project, which provides funding to convert hundreds of European observational health databases to the OMOP CDM and thereby builds a strong basis for the federated data partner network participating in DARWIN EU®.
The selection of data partners is based on several criteria, including aspects on data quality and governance. In the establishment phase of DARWIN EU®, priority is also given to healthcare databases that are already converted to the OMOP CDM. In the operational phase, data sources that are highly valued for conducting studies for the EU medicines regulatory network will be mapped to the OMOP CDM. It goes without saying that all data partners will go through a quality assurance process approved by the EMA.
Continuous data quality assurance
As a subcontractor of the DARWIN EU® CC, The Hyve is responsible for data quality assurance. The Hyve’s OMOP experts support data partners joining the network and ensure data quality by reviewing the outputs of the data quality dashboard (DQD) and the CDM onboarding report provided by the data partner candidates. Our findings are discussed in an interview session with the respective data partners and, if needed, guidance is provided on how to improve the data quality.