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The European Medicines Agency has announced the establishment of the Data Analysis and Real World Interrogation Network (DARWIN EU®) to support better decision making on the development and effectiveness of medicines and vaccines.

DARWIN EU®, will deliver real-world evidence from across Europe on the use, safety, and effectiveness of medicines for human use, including vaccines, from real-world healthcare databases across the European Union (EU).

Erasmus University Medical Centre has been named as the Coordination Centre for DARWIN EU®. Its role is to develop and manage a network of real-world healthcare data sources across the EU and to conduct scientific studies requested by medicines regulators and, at a later stage, requested by other stakeholders.

NDORMS has been subcontracted to the Coordination Centre to contribute analytics and data to the analysis of drug and vaccine safety.

Daniel Prieto-Alhambra, Professor of Pharmaco- and Device Epidemiology described the initiative as a gamechanger in the way drug studies will be performed internationally to benefit patients and healthcare professionals. He said: "Our Pharmaco- and Device Epidemiology team at NDORMS will be one of the key contributors to this initiative. With our knowledge of statistics, epidemiology, and health data sciences, we will co-lead on the design and programming of analytical pipelines for the study of the use, safety, and effectiveness of medicines and vaccines in Europe."

DARWIN EU® will be able to leverage the existing work Oxford has contributed to within the European Health Data and Evidence Network (EHDEN) project funded by the Innovative Medicines Initiative (IMI), and the Observational Health Data Sciences and Informatics (OHDSI) community.

"DARWIN EU® will be transformative for the use of real-world healthcare data in Europe. Building on our work from before and during the COVID-19 pandemic on conducting research using databases from across Europe, we will be establishing the analytic pipelines to rapidly generate evidence to inform regulatory decision making while maintaining patient privacy and ensuring methodological rigour," said Ed Burn, Senior Researcher in Epidemiology and Health Economics at NDORMS.

The vision of DARWIN EU® is to give EMA and national competent authorities in EU Member States access to valid and trustworthy real-world evidence, for example on diseases, patient populations, and the use, safety and effectiveness of medicines, including vaccines, throughout the lifecycle of a medicinal product.

By supporting decision-making on the development, authorisation and surveillance of medicines, a wide range of stakeholders will benefit, from patients and healthcare professionals to health technology assessment bodies and the pharmaceutical industry. Additionally, DARWIN EU® will provide an invaluable resource to prepare for and respond to future healthcare crises and pandemics.

More from Professor Daniel Prieto-Alhambra and Ed Burn.

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