Toward the Use of Real‐World Data for Regulatory and HTA Decision‐Making: Experiences and Recommendations from Six EU ‐Funded Projects
Year: 2026
Type: article
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.
DOI: 10.1002/cpt.70502
Authors: Martin Russek, Jonas Peltner, Kerstin Pfeifer, Theodoros N. Arvanitis, Dirk De Valck, Sieta T. de Vries, Michel Dumontier, Vera Ehrenstein, Omaima El Hakouni, Gregory Epiphaniou, Gokhan Ertaylan, Joana Fernandes, Scott Hansen, Stuart Harrison, Erzsébet Horváth‐Puhó, Saif Ul Islam, Pekka Kahri, Julia K. Mader, Carsten Maple, Nikolaos Matragkas, Shivani Misra, Peter G.M. Mol, Anne Paakinaho, Sami Pakarinen, Martina Radanović, Evy Reviers, Kathrine Kold Sørensen, Marco Spruit, Christina Tikka, Anna‐Maija Tolppanen, Christian Torp‐Pedersen, Mirna Vela, Thuan Vo, Puriya Daniel Würtz Yazdanfard, Britta Haenisch
Institutions: Federal Institute for Drugs and Medical Devices, University of Birmingham, University Medical Center Groningen, University of Groningen, Maastricht University, Aarhus University, Medical University of Graz, University of Warwick, Flemish Institute for Technological Research, The Open Group, Helsinki University Hospital, Hospital District of Helsinki and Uusimaa, Commissariat à l'Énergie Atomique et aux Énergies Alternatives, Université Paris-Saclay, CEA Paris-Saclay - Etablissement de Saclay, Laboratoire d'Intégration des Systèmes et des Technologies, Imperial College London, University of Eastern Finland, Finland University, Eastern Finland Laboratory Center, RISE Research Institutes of Sweden, Nordsjællands Hospital, Steno Diabetes Center Copenhagen, Leiden University Medical Center, University of Bonn
Language: English
Subfield: Economics and Econometrics
Domain: Social Sciences
Open Access status: hybrid
Estimated APC paid: $4,410
Awards: G2532208662, G258106459
OpenAlex ID: W7215729683