European Medicines Agency’s aim is that by 2025 DARWIN EU will deliver approximately 150 real-world evidence studies per year
DARWIN EU, a federated network of real-world healthcare databases across the European Union, has selected its first set of eight data partners. Much like PCORnet in the United States, 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.
With PCORnet, data on more than 30 million people annually across the U.S. are accessible via a distributed research network model of eight large clinical research networks and facilitated by a coordinating center.
DARWIN is an acronym for Data Analysis and Real-World Interrogation Network. It is a project of the European Medicines Agency (EMA), a decentralized agency of the European Union (EU) responsible for the scientific evaluation, supervision and safety monitoring of medicines in the EU.
The selected partners include both public and private institutions. EMA said 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.
EMA manages DARWIN EU and oversees the Erasmus University Medical Center Rotterdam, which was appointed as Coordination Centre in February 2022.
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. 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.
Among the prioritization criteria for data partners were that the 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.
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.
Here are the first eight data partners announced:
• Auria Clinical Informatics – Hospital District Southwest Finland (Finland)
https://www.auria.fi/tietopalvelu/en/index.html
• Bordeaux University Hospital – Centre hospitalier universitaire de Bordeaux (France)
https://www.chu-bordeaux.fr/
• Clinical Practice Research Datalink (CPRD) GOLD – University of Oxford (United Kingdom)
• Estonian Biobank – University of Tartu (Estonia)
• Institut Municipal Assistència Sanitària Information System – Consorci Mar Parc de Salut Barcelona (PSMar), together with Fundació Institut Hospital del Mar d’Investigacions Mèdiques (IMIM) (Spain)
• Integrated Primary Care Information – Mieur Implementation and Exploitation B.V. (The
Netherlands)
• Netherlands Cancer Registry – Integraal Kankercentrum Nederland (The Netherlands)
• Sistema d’Informació per al Desenvolupament de la Investigació en Atenció Primària –
Fundación Instituto Universitario para la Investigación en Atención Primaria de Salud Jordi Gol I Gurina (IDIAPJGol) (Spain)
Source: https://www.hcinnovationgroup.com/clinical-it/learning-health-systems-research/news/21288224/darwin-eu-names-realworld-data-partners-for-federated-network