TY  - JOUR
AU  - Depner, Frank Lucas
AU  - Russek, Martin
AU  - Röthlein, Christoph
AU  - Becker, Cornelia
AU  - Peltner, Jonas
AU  - Pfeifer, Kerstin
AU  - Reviers, Evy
AU  - De Valck, Dirk
AU  - Wicherski, Julia
AU  - Hartikainen, Sirpa
AU  - Tolppanen, Anna-Maija
AU  - Haenisch, Britta
TI  - Key Stakeholders' Knowledge, Opinions, and Interests on Real-World Evidence in the Regulatory Process-Results of an EU-Wide Survey.
JO  - Clinical and translational science
VL  - 18
IS  - 12
SN  - 1752-8054
CY  - Oxford
PB  - Wiley-Blackwell
M1  - DZNE-2025-01442
SP  - e70454
PY  - 2025
AB  - 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
KW  - Humans
KW  - Technology Assessment, Biomedical: methods
KW  - Technology Assessment, Biomedical: legislation & jurisprudence
KW  - Surveys and Questionnaires: statistics & numerical data
KW  - Stakeholder Participation
KW  - Health Knowledge, Attitudes, Practice
KW  - Male
KW  - Female
KW  - Decision Making
KW  - Adult
KW  - Middle Aged
KW  - European Union
KW  - RWD (Other)
KW  - RWE (Other)
KW  - patients (Other)
KW  - stakeholders (Other)
KW  - survey (Other)
LB  - PUB:(DE-HGF)16
C6  - pmid:41420643
C2  - pmc:PMC12717853
DO  - DOI:10.1111/cts.70454
UR  - https://pub.dzne.de/record/283030
ER  -