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

Author(s)

Nikolaus Forgó, Veronika Mikl, Dejan Baltic, Ghazaleh Gouya-Lechner, Bernhard Mraz, Tanja Stamm, Markus Zeitlinger, Johannes Pleiner-Duxneuner, Thomas Czypionka, Alexander Degelsegger-Márquez, Herwig Ostermann, Peter Klimek, David Benjamin Lumenta, Robert Scharinger, Michael Strassnig

Abstract

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.

Organisation(s)

Department of Innovation and Digitalisation in Law, Research Platform Governance of digital practices

External organisation(s)

Gesellschaft für Pharmazeutische Medizin E.V. (GPMed), Austrian National Public Health Institute, Competence Centre on Climate and Health, Vienna, Austria., Medizinische Universität Graz, Bundesministerium für Soziales und Konsumentenschutz, Wiener Wissenschafts-, Forschungs- und Technologiefonds (WWTF), IHS - Institut für Höhere Studien und wissenschaftliche Forschung, London School of Economics and Political Science, Medizinische Universität Wien

Journal

Nature

ISSN

0028-0836

Publication date

04-2024

Peer reviewed

Yes

Austrian Fields of Science 2012

505027 Administrative studies

Portal url

https://ucrisportal.univie.ac.at/en/publications/d966adb5-0a86-499a-a069-f66cabc3a06b