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Mikl, V; Baltic, D; Czypionka, T; Degelsegger-Márquez, A; Forgó, N; Gouya-Lechner, G; Herzog, A; Klimek, P; Lumenta, DB; Mraz, B; Ostermann, H; Scharinger, R; Stamm, T; Strassnig, M; Zeitlinger, M; Pleiner-Duxneuner, J.
A national evaluation analysis and expert interview study of real-world data sources for research and healthcare decision-making.
Sci Rep. 2024; 14(1): 9751
Doi: 10.1038/s41598-024-59475-9
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- Co-Autor*innen der Med Uni Graz
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Lumenta David Benjamin
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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 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.
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Humans - administration & dosage
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Decision Making - administration & dosage
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Delivery of Health Care - administration & dosage
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Austria - administration & dosage
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Health Policy - administration & dosage
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Interviews as Topic - administration & dosage
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Information Sources - administration & dosage
- Find related publications in this database (Keywords)
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Real-world data
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Real-world evidence
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Data quality
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Data quality criteria
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Health data use
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Secondary use of health data
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Health data strategy
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FAIR data principles
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Data quality recommendations
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Pharmaceutical research
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Healthcare decision-making
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Quality criteria for RWD in health care
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Gesellschaft f & uuml
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Pharmazeutische Medizin
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GPMed