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000283030 037__ $$aDZNE-2025-01442
000283030 041__ $$aEnglish
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000283030 1001_ $$0P:(DE-2719)9003193$$aDepner, Frank Lucas$$b0$$eFirst author$$udzne
000283030 245__ $$aKey Stakeholders' Knowledge, Opinions, and Interests on Real-World Evidence in the Regulatory Process-Results of an EU-Wide Survey.
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000283030 520__ $$aReal-world data (RWD) and real-world evidence (RWE) are increasingly gaining attention in supporting drug regulatory decision making. This study assessed knowledge, opinions, and usage patterns of key stakeholders regarding the status of RWD/RWE and AI implementation in health technology assessment (HTA) and drug regulation and aimed to identify the primary obstacles hindering adoption of these technologies. Four surveys tailored to different stakeholders were created and disseminated online to the respective target groups, including I) regulatory authorities, HTA bodies, and the pharmaceutical industry, II) academia, III) payers, and IV) patients and physicians. The responses were analyzed using descriptive statistics or qualitative content analysis with inductive coding. The survey was active from May 6, 2024 to June 30, 2024. Altogether, 221 respondents participated in the survey. Among respondents from regulatory/HTA authorities or industry, 75.4% viewed RWD/RWE as important for future decision making. Respondents from this group already using RWD (n = 56) most frequently reported obstacles regarding data quality (89.3%), data access (62.5%), and data-coding standardization (57.1%). Patients and physicians predominantly had positive expectations about the use of RWD/RWE, and 94.3% indicated willingness to share healthcare data for research, but all respondents also expressed concerns, with data privacy being most frequently mentioned (75.5%). The results show that although stakeholders are optimistic about RWD/RWE implementation into regulatory practice, our survey suggests that successful implementation may benefit from further development in several areas, including guideline harmonization, RWD infrastructure optimization and accessibility, and professional education.
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000283030 650_7 $$2Other$$apatients
000283030 650_7 $$2Other$$astakeholders
000283030 650_7 $$2Other$$asurvey
000283030 650_2 $$2MeSH$$aHumans
000283030 650_2 $$2MeSH$$aTechnology Assessment, Biomedical: methods
000283030 650_2 $$2MeSH$$aTechnology Assessment, Biomedical: legislation & jurisprudence
000283030 650_2 $$2MeSH$$aSurveys and Questionnaires: statistics & numerical data
000283030 650_2 $$2MeSH$$aStakeholder Participation
000283030 650_2 $$2MeSH$$aHealth Knowledge, Attitudes, Practice
000283030 650_2 $$2MeSH$$aMale
000283030 650_2 $$2MeSH$$aFemale
000283030 650_2 $$2MeSH$$aDecision Making
000283030 650_2 $$2MeSH$$aAdult
000283030 650_2 $$2MeSH$$aMiddle Aged
000283030 650_2 $$2MeSH$$aEuropean Union
000283030 7001_ $$0P:(DE-2719)9002837$$aRussek, Martin$$b1$$udzne
000283030 7001_ $$0P:(DE-2719)2812311$$aRöthlein, Christoph$$b2
000283030 7001_ $$0P:(DE-2719)9000482$$aBecker, Cornelia$$b3
000283030 7001_ $$0P:(DE-2719)9002192$$aPeltner, Jonas$$b4
000283030 7001_ $$00009-0008-8799-5851$$aPfeifer, Kerstin$$b5
000283030 7001_ $$00000-0002-6044-5234$$aReviers, Evy$$b6
000283030 7001_ $$00000-0001-7868-2820$$aDe Valck, Dirk$$b7
000283030 7001_ $$0P:(DE-2719)9000812$$aWicherski, Julia$$b8
000283030 7001_ $$00000-0002-4714-455X$$aHartikainen, Sirpa$$b9
000283030 7001_ $$00000-0001-9270-9268$$aTolppanen, Anna-Maija$$b10
000283030 7001_ $$0P:(DE-2719)2810511$$aHaenisch, Britta$$b11$$eLast author
000283030 773__ $$0PERI:(DE-600)2433157-0$$a10.1111/cts.70454$$gVol. 18, no. 12, p. e70454$$n12$$pe70454$$tClinical and translational science$$v18$$x1752-8054$$y2025
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