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22/12/2022 - Institutional news

The EMA selected Hospital del Mar Medical Research Institute and the Hospital del Mar  to be a Data Partner of the DARWIN EU® data network

The European Medicines Agency selected Hospital del Mar Medical Research Institute and the Hospital del Mar  to be a Data Partner of the DARWIN EU® data network, an EU-wide federated network of high-quality observational healthcare databases across Europe, that provides expertise and services to support regulatory decision-making throughout the lifecycle of medicinal products.  

The Hospital del Mar and the Hospital del Mar Medical Research Institute (IMIM) is one of the first eight European centres currently selected to participate in the European Union's DARWIN EU® initiative to carry out multicentre observational studies on medicines. 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.

DARWIN EU® is a federated network which gives the European medicines regulatory network, composed of national competent authorities in the EU Member States, EMA and the European Commission, access to results from analysis of data from real-world healthcare databases across the EU whenever needed and supporting decision making throughout the lifecycle of a medicine. Knowledge of diseases, medicines use and how medicines perform in clinical practice can inform regulatory decision making and support the development, authorisation and safe and effective use of medicines by patients.

From left to right: Jordi Martínez, Juan Manuel Ramírez, Miguel Ángel Mayer, Ángela Leis, Francesc Cots and Marta Carbonell

EMA manages DARWIN EU® and oversees the Erasmus University Medical Center Rotterdam which was appointed as the DARWIN EU® Coordination Centre in February 2022.

Dr. Miguel Ángel Mayer, from the Management Control Department and scientific coordinator of the Hospital del Mar and the IMIM in this project, stresses the importance of these two institutions participating in this initiative. "The fact that we have been chosen as one of the first centres to participate in the first studies from DARWIN EU® initiative is for us the recognition of the excellent work carried out during the last years", he points out. Three of the centre's departments are involved in the project: Innovation and Digital Transformation, Information Systems and Management Control.

Common Data Model (CDM)

The aim of the DARWIN EU® initiative is to promote research on medicines accross the healthcare domain. For this reason, a diverse set of both public and private data partners will be selected from primary care, hospitals and biobanks. The aim is to create a federated network that will make it possible to generate scientific evidence on the use, safety and effectiveness of human medicines, including vaccines.

To make this possible, the selected institutions have their data standardised to the Observational Medical Outcomes Partnership (OMOP) Common Data Model, standards that make it possible to carry out standardised analyses in data networks in a much shorter time than is usual in these types of studies.

The use of standards such as OMOP is part of the global strategy developed by the Hospital del Mar to promote the use of real-life data and generate evidence, improving the secondary use of data, together with other projects, such as the introduction of the REDCAP database management application for clinical studies or cBioportal for the secondary use of data and the integration of medical and clinical data.

Participation in the DARWIN EU® initiative will allow the institutions to increase collaboration in this field with other centres of reference and open doors to new collaborative projects, not only at the European level for the benefit of society, patients and citizens.

You can find more information about this initiative at this link.

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