Toward the Use of Real‐World Data for Regulatory and HTA Decision‐Making: Experiences and Recommendations from Six EU ‐Funded Projects
Abstract
Real-world data are increasingly important for regulatory and health technology assessment decision-making, yet their effective use across Europe remains limited by technical, methodological, regulatory, and societal challenges. Drawing on the experiences of six Horizon Europe projects in the MetReal cluster, this review summarizes common barriers and emerging solutions for the use of real-world data in regulatory decision-making. Key challenges include complex and lengthy data access procedures, fragmented governance frameworks, variable data quality and completeness, limited interoperability, methodological difficulties in analyzing heterogeneous datasets, and infrastructure constraints within secure data environments. The article highlights opportunities to address these barriers through improved metadata, harmonization, federated analytics, synthetic data sandboxes, sustainable funding, and stronger collaboration between researchers, regulators, health technology assessment bodies, data holders, and citizens. These recommendations aim to strengthen Europe's health data ecosystem and support more robust, efficient, and trusted evidence generation for public health and patient benefit.
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Authors: Martin Russek, Jonas Peltner, Kerstin Pfeifer, Theodoros N. Arvanitis, Dirk DE VALCK, Sieta T. de Vries, Michel Dumontier, Véra Ehrenstein, Omaima el Hakouni, Gregory Epiphaniou, Gökhan Ertaylan, Joana Fernandes, Scott Hansen, Stuart Harrison, Erzsébet Horváth–Puhó, Saif ul Islam, Pekka Kahri, Julia Katharina Mader, Carsten R. Maple, Nicholas Matragkas, Shivani Misra, Peter G. M. Mol, Anne Paakinaho, Sami Pakarinen, Martina Radanović, Evy Reviers, Kathrine Kold Sørensen, Marco René Spruit, Christina Tikka, Anna‐Maija Tolppanen, Christian Tobias Torp-Pedersen, Mirna Vela, Sirenda Vong, Puriya Daniel Würtz Yazdanfard, Britta Haenisch
Institutions: University Medical Center Groningen, University of Groningen, Leiden University Medical Center, Imperial College London, Commissariat à l'Énergie Atomique et aux Énergies Alternatives, Maastricht University, University of Bonn, Helsinki University Hospital, Aarhus University, University of Birmingham, Université Paris-Saclay, Medical University of Graz, Flemish Institute for Technological Research, University of Eastern Finland, University of Warwick, Laboratoire d'Intégration des Systèmes et des Technologies, Federal Institute for Drugs and Medical Devices, Eastern Finland Laboratory Center, Finland University, Hospital District of Helsinki and Uusimaa, RISE Research Institutes of Sweden, CEA Paris-Saclay - Etablissement de Saclay, Steno Diabetes Center Copenhagen, Nordsjællands Hospital, The Open Group