The Innovative Medicines Initiative (IMI) project, European Health Data & Evidence Network (EHDEN) is delighted to announce its involvement in establishing a European framework and research network for the conduct of multicentre cohort studies on the use of medicines in COVID-19 patients. The European Medicines Agency (EMA) has announced a one-year EMA-funded project, which includes data sources from eight European countries standardised to the OMOP-Common Data Model and is contracted to IQVIA as the coordinating partner.

Two leading EHDEN partners are actively involved in this project, its lead academic institution, Erasmus Medical Centre, Rotterdam, and its research coordinator, University of Oxford. Associate Professor Peter Rijnbeek, Erasmus Medical Centre, Rotterdam, and Coordinator of EHDEN said, “This is precisely what EHDEN was set up for: creating an international, open science network in Europe, based on a common data model, standardised analytics, tools, and methodologies.” He went on to state, “It’s exciting to participate in this project and further strengthen our collaboration with the EMA.”

Professor Dani Prieto Alhambra, University of Oxford, and Research Coordinator of EHDEN stated, “COVID-19 continues to have a significant impact across the globe.  A critical issue is the need for relevant data to generate evidence and insights to inform decision makers, whether clinicians, governments or regulatory agencies, and we are looking forward to deepening our collaboration on this.”

EHDEN is developing a federated research network, based on data harmonisation and standardised analytics within the Observational Health Data Sciences & Informatics (OHDSI) global initiative. The project is currently working with twenty-five Data Partners in ten European countries on mapping their COVID-19 clinical data to the common data model. This is in response to a rapid collaboration call, earlier in May, in which EHDEN made available a budget of €1 million in financial support. This initiative is aligned with the European Medicines Agency’s need to expand its potential Data Partner network for current and future research for COVID-19 and wider therapeutic domains.

Over the coming year of the new project, and in parallel in EHDEN, considerable work will be undertaken to bring relevant Data Partners, acknowledged experts and contemporary research tools to bear on the ongoing pandemic, to perform a multinational pilot study, and to prepare for future waves and other pandemics.

It will be critical for the development of medicines that real world, observational research can evaluate their effectiveness, alongside repurposed drugs. Nigel Hughes, Scientific Director, Janssen, and Industry Lead in the EHDEN consortium on behalf of the eleven pharmaceutical companies involved agreed with his colleagues, “It’s a critical imperative to all of us that we can accelerate the speed to answers in healthcare, without impacting on the quality of those answers, and in the case of COVID-19, and in general, this needs to happen today and not in several tomorrows. Patients simply cannot afford to wait.”

ENDS
 
The European Health Data & Evidence Network (EHDEN)
A project within the Innovative Medicines Initiative (IMI) and is part of its Big Data For Better Health Outcomes (BD4BO) initiative. EHDEN is a group of twenty-two partners: eleven public organisations and eleven pharmaceutical companies. Its mission is to develop a federated network, standardised to a common data model, that more smartly shares and manages real-world data and research methodologies, and expands education in open science and collaboration, ultimately to increase the speed to evidence generation and improving outcomes for patients. To learn more about EHDEN and its vision to enable better health decisions, outcomes and care across Europe, visit our website.

The European Health Data & Evidence Network has received funding from the Innovative Medicines Initiative 2 Joint Undertaking (JU) under grant agreement No 806968. The JU receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA.