First DARWIN EU® real-world evidence studies conducted and call for new data partners

European Medicines Agency reports the inaugural four real-world data studies of DARWIN EU®, the Data Analysis and Real-World Interrogation Network, and invites expressions of interest from potential second round data partners.   

On 28 March 2023, the European Medicines Agency (EMA) issued a press release reporting the first-year progress of the Data Analysis and Real-World Interrogation Network DARWIN EU since the establishment of its Coordination Centre in February 2022. With ten initial real-world data (RWD) partners, the initiative has conducted four inaugural real-world evidence (RWE) studies. The network plans to onboard ten additional data partners and initiate around 16 studies during 2023, and invites expression of interest from potential second round data collaborators.  

DARWIN EU is a platform developed to generate RWE using RWD from across Europe, to better understand diseases, populations and the uses and effects of medicines, and specifically to support the decision-making of EMA scientific committees and national competent authorities in European Union (EU) member states throughout regulatory processes. The vision is that DARWIN EU will be fully operational by 2025, delivering around 150 RWE studies per year, with use of RWE having established value across the spectrum of regulatory cases. 

Prospective new data partners for 2023 are now invited to visit the DARWIN EU website for application information. The next ten additional data partners can be public or private institutions with access to real-world healthcare data from sources such as hospitals, primary care, health insurance, registries or biobanks.  

The protocols and results of the four inaugural DARWIN EU studies are publicly available in the EU electronic Register of Post-Authorisation Studies. The study topics are: 

• the prevalence of rare blood cancers in five European countries; 
• use of valproate in females aged 12–55 years, in relation to potential fetal harm; 
• characterization of prescription patterns for 141 antibiotics on the World Health Organization Watch List, in regard to antimicrobial resistance and guidelines; 
• safety assessment of all products authorized or under development for treatment of severe asthma in adolescents and adults. 

The design and conduct of the first studies have supported the establishment of analytical pipelines and processes. The use of a common data model and standardized analytics within DARWIN EU is already demonstrating benefits in facilitating faster study performance, increased capacity and lower costs.  

Throughout 2023, DARWIN EU will be working on use case pilots with the European Centre for Disease Prevention, and bodies responsible for health technology assessments and those representing payers. It is also participating in a pilot for the European Health Data Space (EHDS), exploring the network’s role as a research and data node — DARWIN EU acts as a pathfinder for the EHDS and will ultimately connect to the EHDS services.