{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,2]],"date-time":"2026-10-02T08:53:42Z","timestamp":1790931222168,"version":"4.1.0"},"reference-count":31,"publisher":"Wiley","license":[{"start":{"date-parts":[[2026,10,2]],"date-time":"2026-10-02T00:00:00Z","timestamp":1790899200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2026,10,2]],"date-time":"2026-10-02T00:00:00Z","timestamp":1790899200000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["ascpt.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clin Pharma and Therapeutics"],"abstract":"<jats:p>Real\u2010world data are increasingly important for regulatory and health technology assessment decision\u2010making, 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\u2010world data in regulatory decision\u2010making. 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.<\/jats:p>","DOI":"10.1002\/cpt.70502","type":"journal-article","created":{"date-parts":[[2026,10,2]],"date-time":"2026-10-02T08:10:36Z","timestamp":1790928636000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Toward the Use of Real\u2010World Data for Regulatory and\n                    <scp>HTA<\/scp>\n                    Decision\u2010Making: Experiences and Recommendations from Six\n                    <scp>EU<\/scp>\n                    \u2010Funded Projects"],"prefix":"10.1002","author":[{"ORCID":"https:\/\/orcid.org\/0009-0007-9509-0342","authenticated-orcid":false,"given":"Martin","family":"Russek","sequence":"first","affiliation":[{"name":"Research Division Federal Institute for Drugs and Medical Devices  Bonn 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