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Professor Daniel Prieto-Alhambra of NDORMS will lead a work package on the generation of evidence from European wide observational data as part of a new Innovative Medicines Initiative project, the European Health Data & Evidence Network (EHDEN).

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The five-year IMI2 EHDEN programme will harmonise clinical data and develop a 21st century ecosystem for real world health research in Europe

"We are extremely excited to contribute to this project. EHDEN will be a game-changer for European international collaboration in observational research", says Professor Prieto-Alhambra.

Today, in Europe, we are challenged to generate insights and evidence from real world clinical data at scale, to support patients, clinicians, payers, regulators, governments, and the pharmaceutical industry in understanding wellbeing, disease, treatments, outcomes and new therapeutics and devices. Unfortunately, such data is difficult to use at scale, in a myriad of languages, systems and structures, with challenging policy restrictions and technology considerations.

Consequently, using real world data for research, reflective of what happens for patients in their own experience of healthcare, is very challenging. “Every day, patients throughout Europe are being denied optimal care because we are not able to create sufficient insights that lead to improved systems, services, and new treatment options,” said Nicola Bedlington, Secretary General, European Patients Forum, an EHDEN partner.

In response to this, the EHDEN public private project was set up under the framework of IMI2, with twenty-two partners, including academia, SMEs, patient associations, regulatory authorities and pharmaceutical companies, led by Erasmus Medical Centre, The Netherlands, and Janssen Pharmaceutica N.V., Belgium. The mission of EHDEN is to provide a new paradigm for the discovery and analysis of health data in Europe, by building a large-scale, federated network of data sources standardised to a common data model. EHDEN will build on prior projects, such as EMIF and EHR4CR, in scaling their original intents and technologies.

Dr Peter Rijnbeek, Erasmus MC, Coordinator of EHDEN stated, “We have a critical need to improve how we conduct health research at scale, across borders throughout Europe. We need to develop the technical infrastructure, partnerships and collaborations to support this.” EHDEN will establish a federated network of data sources, such as hospitals and primary care networks across Europe.

Central to EHDEN will be the standardisation of health data to the OMOP common data model and the utilisation of analytical tools such as those developed by the international Observational Health Data Sciences and Informatics (OHDSI) open science collaboration (www.ohdsi.org), and others. A network of SMEs will be trained and certified to ensure high validity transformation of data to the common data model.

EHDEN’s aspirations are significant, aiming to harmonise 100 million, anonymised health records across multiple data sources, who can obtain funding from the EHDEN Harmonisation Fund to obtain support from certified/qualified SMEs through serial open calls. The project will support other IMI2 projects within a wider Big Data for Better Outcomes (BD4BO) programme, other IMI and non-IMI projects, and will collaborate strongly with other key stakeholders in Europe, such as the European Medicines Agency.

“We believe EHDEN is a flagship project, and it will be significantly influential,” said Nigel Hughes, Project Leader for EHDEN at Janssen, “building on the heritage and developments of prior and current projects in and out of IMI, and it will establish 21st century tools for 21st research.” Peter Rijnbeek added, “As such it will impact on European health records research for years and decades to come, and will enable better health decisions, outcomes and care.”

For more information please contact the project via enquiries@EHDEN.eu.

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