EU regulators seeks new partners for real-world data network

Real-world data looks set to play an increasingly important role in how medicines are assessed for safety and effectiveness in Europe. The Data Analysis and Real-World Interrogation Network (DARWIN EU), set up to build regulatory capacity in this fast-moving field, is now seeking ten new data partners.

The network currently has 20 public or private institutions from 13 European countries. These partner organisations generate real-world evidence (RWE) from sources such as hospitals, primary care, health insurance, registries and biobanks to support the work of the European Medicines Agency’s (EMA) scientific committees and national regulators in the EU.

Data partners enable access to data from approximately 130 million patients across Europe, which significantly increases DARWIN EU’s capacity to deliver valid and reliable evidence based on RWD studies.

A key design feature of DARWIN EU is that the data are converted into a common data model. In addition, data stays local and is analysed locally by the data partners. This combination of features enables personal data protection by design and the rapid conduct of big, multi-database studies.

The network was set up in February 2022 and has completed fourteen real-world data (RWD) studies – a further eleven are ongoing. They cover drug utilisation, vaccine effectiveness, disease epidemiology and patient characterisation, helping EU regulators to better understand diseases, populations and the uses and performance of medicines.

The EMA says RWE complements information from clinical trials and other evidence in regulatory decision making and can be relevant for a wide range of topics and therapeutic areas.

The output of studies will be further scaled up with the onboarding of the new data partners in 2024, and another ten in 2025. The aim is to deliver over 70 RWD studies this year, and over 140 studies per year from 2025 onwards to enhance more data-driven decision making on medicines in the EU.