A national evaluation analysis and expert interview study of real-world data sources for research and healthcare decision-making.

Autor: Mikl V; Gesellschaft für Pharmazeutische Medizin E.V. (GPMed), 1210, Vienna, Austria.; Roche Austria GmbH, Vienna, Austria., Baltic D; Gesellschaft für Pharmazeutische Medizin E.V. (GPMed), 1210, Vienna, Austria.; Amgen GmbH, Vienna, Austria., Czypionka T; Institut für Höhere Studien - Institute for Advanced Studies (IHS), 1080, Vienna, Austria., Degelsegger-Márquez A; Gesundheit Österreich GmbH (GÖG), 1010, Vienna, Austria., Forgó N; Faculty of Law, Department of Innovation and Digitalisation in Law, University of Vienna, 1010, Vienna, Austria., Gouya-Lechner G; Gesellschaft für Pharmazeutische Medizin E.V. (GPMed), 1210, Vienna, Austria.; Gouya Insights GmbH & CoKG, 1190, Vienna, Austria., Herzog A; Austrian Medicines and Medical Devices Agency (AGES Medizinmarktaufsicht), 1220, Vienna, Austria., Klimek P; Supply Chain Intelligence Institute Austria (ASCII), 1080, Vienna, Austria.; Section for Science of Complex Systems, Center for Medical Statistics, Informatics, and Intelligent Systems, Medical University Vienna, 1090, Vienna, Austria.; Complexity Science Hub Vienna, 1080, Vienna, Austria., Lumenta DB; Research Unit for Digital Surgery, Division of Plastic, Aesthetic and Reconstructive Surgery, Department of Surgery, Medical University of Graz, 8036, Graz, Austria., Mraz B; Gesellschaft für Pharmazeutische Medizin E.V. (GPMed), 1210, Vienna, Austria.; Novartis Pharma GmbH, Vienna, Austria., Ostermann H; Gesundheit Österreich GmbH (GÖG), 1010, Vienna, Austria., Scharinger R; Federal Ministry of Social Affairs, Health, Care and Consumer Protection, 1010, Vienna, Austria., Stamm T; Gesellschaft für Pharmazeutische Medizin E.V. (GPMed), 1210, Vienna, Austria.; Section for Outcomes Research, Center for Medical Statistics, Informatics, and Intelligent Systems, Medical University of Vienna, Medical University Vienna, 1090, Vienna, Austria., Strassnig M; Wiener Wissenschafts-, Forschungs- und Technologiefonds (Vienna Science and Technology Fund), 1090, Vienna, Austria.; Expertenplattform Plattform Registerforschung, c/o WWTF, 1090, Vienna, Austria., Zeitlinger M; Gesellschaft für Pharmazeutische Medizin E.V. (GPMed), 1210, Vienna, Austria.; Department of Clinical Pharmacology, Medical University Vienna, 1090, Vienna, Austria., Pleiner-Duxneuner J; Gesellschaft für Pharmazeutische Medizin E.V. (GPMed), 1210, Vienna, Austria. johannes.pleiner@gpmed.at.; Roche Austria GmbH, Vienna, Austria. johannes.pleiner@gpmed.at.
Jazyk: angličtina
Zdroj: Scientific reports [Sci Rep] 2024 Apr 28; Vol. 14 (1), pp. 9751. Date of Electronic Publication: 2024 Apr 28.
DOI: 10.1038/s41598-024-59475-9
Abstrakt: Real-world data (RWD) can provide intel (real-world evidence, RWE) for research and development, as well as policy and regulatory decision-making along the full spectrum of health care. Despite calls from global regulators for international collaborations to integrate RWE into regulatory decision-making and to bridge knowledge gaps, some challenges remain. In this work, we performed an evaluation of Austrian RWD sources using a multilateral query approach, crosschecked against previously published RWD criteria and conducted direct interviews with representative RWD source samples. This article provides an overview of 73 out of 104 RWD sources in a national legislative setting where major attempts are made to enable secondary use of RWD (e.g. law on the organisation of research, "Forschungsorganisationsgesetz"). We were able to detect omnipresent challenges associated with data silos, variable standardisation efforts and governance issues. Our findings suggest a strong need for a national health data strategy and data governance framework, which should inform researchers, as well as policy- and decision-makers, to improve RWD-based research in the healthcare sector to ultimately support actual regulatory decision-making and provide strategic information for governmental health data policies.
(© 2024. The Author(s).)
Databáze: MEDLINE
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