%0 Journal Article
%A Depner, Frank Lucas
%A Russek, Martin
%A Röthlein, Christoph
%A Becker, Cornelia
%A Peltner, Jonas
%A Pfeifer, Kerstin
%A Reviers, Evy
%A De Valck, Dirk
%A Wicherski, Julia
%A Hartikainen, Sirpa
%A Tolppanen, Anna-Maija
%A Haenisch, Britta
%T Key Stakeholders' Knowledge, Opinions, and Interests on Real-World Evidence in the Regulatory Process-Results of an EU-Wide Survey.
%J Clinical and translational science
%V 18
%N 12
%@ 1752-8054
%C Oxford
%I Wiley-Blackwell
%M DZNE-2025-01442
%P e70454
%D 2025
%X Real-world data (RWD) and real-world evidence (RWE) are increasingly gaining attention in supporting drug regulatory decision making. This study assessed knowledge, opinions, and usage patterns of key stakeholders regarding the status of RWD/RWE and AI implementation in health technology assessment (HTA) and drug regulation and aimed to identify the primary obstacles hindering adoption of these technologies. Four surveys tailored to different stakeholders were created and disseminated online to the respective target groups, including I) regulatory authorities, HTA bodies, and the pharmaceutical industry, II) academia, III) payers, and IV) patients and physicians. The responses were analyzed using descriptive statistics or qualitative content analysis with inductive coding. The survey was active from May 6, 2024 to June 30, 2024. Altogether, 221 respondents participated in the survey. Among respondents from regulatory/HTA authorities or industry, 75.4
%K Humans
%K Technology Assessment, Biomedical: methods
%K Technology Assessment, Biomedical: legislation & jurisprudence
%K Surveys and Questionnaires: statistics & numerical data
%K Stakeholder Participation
%K Health Knowledge, Attitudes, Practice
%K Male
%K Female
%K Decision Making
%K Adult
%K Middle Aged
%K European Union
%K RWD (Other)
%K RWE (Other)
%K patients (Other)
%K stakeholders (Other)
%K survey (Other)
%F PUB:(DE-HGF)16
%9 Journal Article
%$ pmid:41420643
%2 pmc:PMC12717853
%R 10.1111/cts.70454
%U https://pub.dzne.de/record/283030