DARWIN EU® continues expanding its capacity to deliver real-world data studies

6 March 2024

The Data Analysis and Real World Interrogation Network DARWIN EU seeks ten new data partners in 2024.

The Data Analysis and Real World Interrogation Network DARWIN EU will continue working towards higher capacity for real-world data (RWD) studies and seeks to add ten new data partners in 2024.

Currently, the network operates with 20 public or private institutions from 13 European countries. The data partners generate real-world evidence (RWE) from sources such as hospitals, primary care, health insurance, registries and biobanks to support regulatory activities of EMA’s scientific committees and national regulators in the EU.

The 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 conduction of big, multi-database studies.

The network has now completed its establishment two years after the Coordination Centre was set up in February 2022. Since then, 14 RWD studies have been completed and eleven are ongoing. They cover drug utilisation, vaccine effectiveness, disease epidemiology and patient characterisation and help EU regulators to better understand diseases, populations and the uses and performance of medicines.

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. As an example, two recently completed studies focus on:

• investigating treatment patterns for medicines used in adults and children with systemic lupus erythematosus (SLE), a multisystem autoimmune disorder of connective tissue. The study examined patients diagnosed with SLE between 2013 and 2022. It has served EMA’s Paediatric Committee (PDCO) by providing information on the paediatric SLE population potentially available for clinical trials and on the similarities between adults and children;
• understanding the patient characteristics, treatment patterns and chances of survival in multiple myeloma, a rare cancer of a type of white blood cells called plasma cells found in the bone marrow, focusing on over 30,000 patients diagnosed between 2012 and 2022 across Europe. The study is the first of two use cases piloting the use of RWD generated via DARWIN EU for decision making by health technology assessment (HTA) bodies and payers.

The results from the completed studies have been shared with the relevant EMA committees and other stakeholders to support their work. Once finalised, the protocols and results of all DARWIN EU studies are publicly available in the new HMA-EMA Catalogue of RWD studies.

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.