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

Mikl, Veronika; Baltic, Dejan; Czypionka, ThomasORCID: https://orcid.org/0000-0002-3381-1075; Degelsegger-Márquez, Alexander; Forgó, Nikolaus; Gouya-Lechner, Ghazaleh; Herzog, Arnold; Klimek, Peter; Lumenta, David Benjamin; Mraz, Bernhard; Ostermann, Herwig; Scharinger, Robert; Stamm, Tanja; Strassnig, Michael; Zeitlinger, Markus and Pleiner-Duxneuner, Johannes (2023) A national evaluation analysis and expert interview study of real-world data sources for research and healthcare decision-making. Scientific Reports. DOI: 10.21203/rs.3.rs-3423573/v1

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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 with favourable RWD incentives, which can be used to extrapolate to other EU data regions under the General Data Protection Regulation (GDPR) and upcoming legislation such as the European Health Data Space Act (EHDS). 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 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.

Item Type: Article in Academic Journal
Keywords: Health sciences/Health care, Health sciences/Health care/Health policy, real-world data, real-world evidence, data quality, data quality criteria, health data use, secondary use of health data, health data strategy, FAIR data principles, data quality recommendations, pharmaceutical research, healthcare decision-making, quality criteria for RWD in health care, Gesellschaft für Pharmazeutische Medizin, GPMed
Research Units: Current Research Groups > Health Economics and Health Policy
Date Deposited: 07 Nov 2023 08:35
Last Modified: 19 Feb 2024 10:49
DOI: 10.21203/rs.3.rs-3423573/v1
ISSN: 2045-2322
URI: https://irihs.ihs.ac.at/id/eprint/6756

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