Home > Publications Database > Key Stakeholders' Knowledge, Opinions, and Interests on Real-World Evidence in the Regulatory Process-Results of an EU-Wide Survey. > print

001     283030
005     20260103103702.0
024 7 _ |a 10.1111/cts.70454
|2 doi
024 7 _ |a pmid:41420643
|2 pmid
024 7 _ |a pmc:PMC12717853
|2 pmc
024 7 _ |a 1752-8054
|2 ISSN
024 7 _ |a 1752-8062
|2 ISSN
037 _ _ |a DZNE-2025-01442
041 _ _ |a English
082 _ _ |a 610
100 1 _ |a Depner, Frank Lucas
|0 P:(DE-2719)9003193
|b 0
|e First author
|u dzne
245 _ _ |a Key Stakeholders' Knowledge, Opinions, and Interests on Real-World Evidence in the Regulatory Process-Results of an EU-Wide Survey.
260 _ _ |a Oxford
|c 2025
|b Wiley-Blackwell
336 7 _ |a article
|2 DRIVER
336 7 _ |a Output Types/Journal article
|2 DataCite
336 7 _ |a Journal Article
|b journal
|m journal
|0 PUB:(DE-HGF)16
|s 1766405257_14399
|2 PUB:(DE-HGF)
336 7 _ |a ARTICLE
|2 BibTeX
336 7 _ |a JOURNAL_ARTICLE
|2 ORCID
336 7 _ |a Journal Article
|0 0
|2 EndNote
520 _ _ |a 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% viewed RWD/RWE as important for future decision making. Respondents from this group already using RWD (n = 56) most frequently reported obstacles regarding data quality (89.3%), data access (62.5%), and data-coding standardization (57.1%). Patients and physicians predominantly had positive expectations about the use of RWD/RWE, and 94.3% indicated willingness to share healthcare data for research, but all respondents also expressed concerns, with data privacy being most frequently mentioned (75.5%). The results show that although stakeholders are optimistic about RWD/RWE implementation into regulatory practice, our survey suggests that successful implementation may benefit from further development in several areas, including guideline harmonization, RWD infrastructure optimization and accessibility, and professional education.
536 _ _ |a 354 - Disease Prevention and Healthy Aging (POF4-354)
|0 G:(DE-HGF)POF4-354
|c POF4-354
|f POF IV
|x 0
588 _ _ |a Dataset connected to CrossRef, PubMed, , Journals: pub.dzne.de
650 _ 7 |a RWD
|2 Other
650 _ 7 |a RWE
|2 Other
650 _ 7 |a patients
|2 Other
650 _ 7 |a stakeholders
|2 Other
650 _ 7 |a survey
|2 Other
650 _ 2 |a Humans
|2 MeSH
650 _ 2 |a Technology Assessment, Biomedical: methods
|2 MeSH
650 _ 2 |a Technology Assessment, Biomedical: legislation & jurisprudence
|2 MeSH
650 _ 2 |a Surveys and Questionnaires: statistics & numerical data
|2 MeSH
650 _ 2 |a Stakeholder Participation
|2 MeSH
650 _ 2 |a Health Knowledge, Attitudes, Practice
|2 MeSH
650 _ 2 |a Male
|2 MeSH
650 _ 2 |a Female
|2 MeSH
650 _ 2 |a Decision Making
|2 MeSH
650 _ 2 |a Adult
|2 MeSH
650 _ 2 |a Middle Aged
|2 MeSH
650 _ 2 |a European Union
|2 MeSH
700 1 _ |a Russek, Martin
|0 P:(DE-2719)9002837
|b 1
|u dzne
700 1 _ |a Röthlein, Christoph
|0 P:(DE-2719)2812311
|b 2
700 1 _ |a Becker, Cornelia
|0 P:(DE-2719)9000482
|b 3
700 1 _ |a Peltner, Jonas
|0 P:(DE-2719)9002192
|b 4
700 1 _ |a Pfeifer, Kerstin
|0 0009-0008-8799-5851
|b 5
700 1 _ |a Reviers, Evy
|0 0000-0002-6044-5234
|b 6
700 1 _ |a De Valck, Dirk
|0 0000-0001-7868-2820
|b 7
700 1 _ |a Wicherski, Julia
|0 P:(DE-2719)9000812
|b 8
700 1 _ |a Hartikainen, Sirpa
|0 0000-0002-4714-455X
|b 9
700 1 _ |a Tolppanen, Anna-Maija
|0 0000-0001-9270-9268
|b 10
700 1 _ |a Haenisch, Britta
|0 P:(DE-2719)2810511
|b 11
|e Last author
773 _ _ |a 10.1111/cts.70454
|g Vol. 18, no. 12, p. e70454
|0 PERI:(DE-600)2433157-0
|n 12
|p e70454
|t Clinical and translational science
|v 18
|y 2025
|x 1752-8054
856 4 _ |y OpenAccess
|u https://pub.dzne.de/record/283030/files/DZNE-2025-1442.pdf
856 4 _ |y OpenAccess
|x pdfa
|u https://pub.dzne.de/record/283030/files/DZNE-2025-1442.pdf?subformat=pdfa
909 C O |o oai:pub.dzne.de:283030
|p openaire
|p open_access
|p VDB
|p driver
|p dnbdelivery
910 1 _ |a Deutsches Zentrum für Neurodegenerative Erkrankungen
|0 I:(DE-588)1065079516
|k DZNE
|b 0
|6 P:(DE-2719)9003193
910 1 _ |a External Institute
|0 I:(DE-HGF)0
|k Extern
|b 1
|6 P:(DE-2719)9002837
910 1 _ |a Deutsches Zentrum für Neurodegenerative Erkrankungen
|0 I:(DE-588)1065079516
|k DZNE
|b 4
|6 P:(DE-2719)9002192
910 1 _ |a Deutsches Zentrum für Neurodegenerative Erkrankungen
|0 I:(DE-588)1065079516
|k DZNE
|b 11
|6 P:(DE-2719)2810511
913 1 _ |a DE-HGF
|b Gesundheit
|l Neurodegenerative Diseases
|1 G:(DE-HGF)POF4-350
|0 G:(DE-HGF)POF4-354
|3 G:(DE-HGF)POF4
|2 G:(DE-HGF)POF4-300
|4 G:(DE-HGF)POF
|v Disease Prevention and Healthy Aging
|x 0
914 1 _ |y 2025
915 _ _ |a DBCoverage
|0 StatID:(DE-HGF)0200
|2 StatID
|b SCOPUS
|d 2024-12-27
915 _ _ |a DBCoverage
|0 StatID:(DE-HGF)0300
|2 StatID
|b Medline
|d 2024-12-27
915 _ _ |a DBCoverage
|0 StatID:(DE-HGF)1050
|2 StatID
|b BIOSIS Previews
|d 2024-12-27
915 _ _ |a DBCoverage
|0 StatID:(DE-HGF)1190
|2 StatID
|b Biological Abstracts
|d 2024-12-27
915 _ _ |a DBCoverage
|0 StatID:(DE-HGF)0600
|2 StatID
|b Ebsco Academic Search
|d 2024-12-27
915 _ _ |a JCR
|0 StatID:(DE-HGF)0100
|2 StatID
|b CTS-CLIN TRANSL SCI : 2022
|d 2024-12-27
915 _ _ |a DEAL Wiley
|0 StatID:(DE-HGF)3001
|2 StatID
|d 2024-12-27
|w ger
915 _ _ |a DBCoverage
|0 StatID:(DE-HGF)0500
|2 StatID
|b DOAJ
|d 2024-08-08T17:07:34Z
915 _ _ |a DBCoverage
|0 StatID:(DE-HGF)0501
|2 StatID
|b DOAJ Seal
|d 2024-08-08T17:07:34Z
915 _ _ |a WoS
|0 StatID:(DE-HGF)0113
|2 StatID
|b Science Citation Index Expanded
|d 2024-12-27
915 _ _ |a DBCoverage
|0 StatID:(DE-HGF)0199
|2 StatID
|b Clarivate Analytics Master Journal List
|d 2024-12-27
915 _ _ |a DBCoverage
|0 StatID:(DE-HGF)0150
|2 StatID
|b Web of Science Core Collection
|d 2024-12-27
915 _ _ |a IF < 5
|0 StatID:(DE-HGF)9900
|2 StatID
|d 2024-12-27
915 _ _ |a OpenAccess
|0 StatID:(DE-HGF)0510
|2 StatID
915 _ _ |a Peer Review
|0 StatID:(DE-HGF)0030
|2 StatID
|b ASC
|d 2024-12-27
915 _ _ |a Article Processing Charges
|0 StatID:(DE-HGF)0561
|2 StatID
|d 2024-12-27
915 _ _ |a DBCoverage
|0 StatID:(DE-HGF)0160
|2 StatID
|b Essential Science Indicators
|d 2024-12-27
915 _ _ |a Creative Commons Attribution CC BY 4.0
|0 LIC:(DE-HGF)CCBY4
|2 HGFVOC
915 _ _ |a Fees
|0 StatID:(DE-HGF)0700
|2 StatID
|d 2024-12-27
920 1 _ |0 I:(DE-2719)1013010
|k AG Hänisch
|l Pharmacoepidemiology
|x 0
980 _ _ |a journal
980 _ _ |a VDB
980 _ _ |a UNRESTRICTED
980 _ _ |a I:(DE-2719)1013010
980 1 _ |a FullTexts

LibraryCollectionCLSMajorCLSMinorLanguageAuthor
Marc 21