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 actionable evidence that will support scientific assessments and regulatory decision-making.
Real-world evidence refers to information derived from the analysis of real-world data, which is routinely collected data about a patient’s health status or healthcare delivery from a variety of sources. other than traditional clinical trials.
With PCORnet, data on more than 30 million people a year across the United States is accessible through a distributed research network model of eight major clinical research networks and facilitated by a coordinating center.
DARWIN is the 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 control of the safety of medicines in the EU.
The selected partners include both public and private institutions. The EMA said the common feature is that they all have access to real health data from one or more sources such as hospitals, primary care, health insurance, biobanks or patient registries. disease specific. The data partners will provide the DARWIN EU coordination center with the results of the analyzes of these data.
EMA manages DARWIN EU and oversees the Erasmus University Medical Center Rotterdam, which was appointed as the Coordinating Center in February 2022.
With the integration of data partners, the EMA has launched the launch of the first three studies which will be provided by DARWIN EU. A study will focus on the epidemiology of rare blood cancers in order to inform on their prevalence in Europe. The second study examines the drug use of valproate and the third examines the use of antibiotics to inform future work on antimicrobial resistance. These studies mark the beginning of a rapid increase in the number of studies conducted to support regulatory decision-making. The goal is that by 2025, DARWIN EU will deliver around 150 hard evidence studies per year.
Among the prioritization criteria for data partners was that sources should have continuous data collection with at least annual data updates, a lag of less than six months in data availability for the analysis and recording of health results and the prescription or dispensing of drugs.
Additionally, the data must be available already converted into the OMOP Common Data Model (CDM) of the Observational Medical Outcomes Partnership, which allows analyzes to be performed using the same analytical code.
The number of data partners will increase in the coming years. The goal is to add at least ten new data partners each 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)
• Bordeaux University Hospital – Bordeaux University Hospital (France)
• Clinical Practice Research Datalink (CPRD) GOLD – University of Oxford (UK)
• Estonian Biobank – University of Tartu (Estonia)
• Information system of the Institut Municipal Assistència Sanitària – Consorci Mar Parc de Salut Barcelona (PSMar), in collaboration with the Fundació Institut Hospital del Mar d’Investigacions Médiques (IMIM) (Spain)
• Information on integrated primary care – Mieur Implementation and Exploitation BV (The
• Dutch Cancer Registry – Integrated Cancer Center Netherlands (Netherlands)
• Information system for the development of research in primary care –
Jordi Gol I Gurina University Institute for Research in Primary Health Care Foundation (IDIAPJGol) (Spain)
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