A national evaluation analysis and expert interview study of real-world data sources for research and healthcare decision-making.
Data quality
Data quality criteria
Data quality recommendations
FAIR data principles
GPMed
Gesellschaft für Pharmazeutische Medizin
Health data strategy
Health data use
Healthcare decision-making
Pharmaceutical research
Quality criteria for RWD in health care
Real-world data
Real-world evidence
Secondary use of health data
Journal
Scientific reports
ISSN: 2045-2322
Titre abrégé: Sci Rep
Pays: England
ID NLM: 101563288
Informations de publication
Date de publication:
28 Apr 2024
28 Apr 2024
Historique:
received:
09
10
2023
accepted:
11
04
2024
medline:
29
4
2024
pubmed:
29
4
2024
entrez:
28
4
2024
Statut:
epublish
Résumé
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.
Identifiants
pubmed: 38679653
doi: 10.1038/s41598-024-59475-9
pii: 10.1038/s41598-024-59475-9
doi:
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
9751Informations de copyright
© 2024. The Author(s).
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