EMA has selected the first set of data partners to collaborate with DARWIN EU®, the Data Analysis and Real-World Interrogation Network. The data available to these partners will be used for studies to generate real-world evidence that will support scientific evaluations and regulatory decision making. Real-world evidence refers to information derived from analysis of real-world data, which is routinely collected data about a patient’s health status or delivery of healthcare from a variety of sources other than traditional clinical trials.
The selected partners include both public and private institutions. The common feature is that they all have access to real-world healthcare data from one or more sources such as hospitals, primary care, health insurance, biobanks, or disease-specific patient registries. The data partners will provide the DARWIN EU® Coordination Centre with results of analyses of these data.
With the onboarding of data partners, EMA has initiated the launch of the first three studies to be provided by DARWIN EU®. One study will focus on the epidemiology of rare blood cancers to inform on their prevalence in Europe. The second study is on drug use of valproate and the third one is looking at the use of antibiotics to inform future work on anti-microbial resistance. EMA will report more details of these studies in due course, including the publication of protocols and reports in the EU PAS register. These studies mark the start of a rapid ramp-up in the number of studies conducted to support regulatory decision making. The aim is that by 2025 DARWIN EU® will deliver approximately 150 real-world evidence studies per year.
Data partners were selected according to prioritisation criteria after consultation with the DARWIN EU® Advisory Board. According to these criteria, sources should have continuous data collection with at least annual data updates, a lag time of less than six months in data availability for analysis and capture of health outcomes and medicines prescribing or dispensing.
In addition, the data should be available already converted into the Observational Medical Outcomes Partnership OMOP Common Data Model (CDM), which allows analyses to be performed using the same analytical code.
Data sources should represent different healthcare settings of medicines use (primary, secondary, specialist use) as well as, collectively, the EU population. Non-EU data sources can be considered for inclusion if they add value to real-world evidence analyses and enrich the results for decision making on medicines.
The number of data partners will increase in the coming years. The target is to add at least ten new data partners every year. In 2023, a call for expressions of interest for potential new data partners will be launched.
DARWIN EU® enables more informed regulatory decision making
DARWIN EU® is a federated network which gives the European medicines regulatory network, composed of national competent authorities in the EU Member States, EMA and the European Commission, access to results from analysis of data from real-world healthcare databases across the EU whenever needed and supporting decision making throughout the lifecycle of a medicine.
Knowledge of diseases, of medicines use and of how medicines perform in clinical practice can inform regulatory decision making and support the development, authorisation and safe and effective use of medicines by patients.
EMA manages DARWIN EU® and oversees the Erasmus University Medical Center Rotterdam which was appointed as the DARWIN EU® Coordination Centre in February 2022.
The network will act as a pathfinder for the proposed European Health Data Space (EHDS), and will ultimately connect to the EHDS services, enabling the use of the EHDS in medicines regulation in Europe.