دورية أكاديمية
أعرض في EDS

Stakeholder perspectives on data sharing from pragmatic clinical trials: Unanticipated challenges for meeting emerging requirements.

التفاصيل البيبلوغرافية
العنوان: Stakeholder perspectives on data sharing from pragmatic clinical trials: Unanticipated challenges for meeting emerging requirements.
المؤلفون: Morain SR; Berman Insitute of Bioethics Johns Hopkins University Baltimore Maryland USA.; Department of Health Policy & Management Johns Hopkins Bloomberg School of Public Health Baltimore Maryland USA., Bollinger J; Berman Insitute of Bioethics Johns Hopkins University Baltimore Maryland USA., Weinfurt K; Department of Population Health Sciences Duke University Medical Center Durham North Carolina USA., Sugarman J; Berman Insitute of Bioethics Johns Hopkins University Baltimore Maryland USA.; Department of Health Policy & Management Johns Hopkins Bloomberg School of Public Health Baltimore Maryland USA.; Department of Medicine School of Medicine, Johns Hopkins Baltimore Maryland USA.
المصدر: Learning health systems [Learn Health Syst] 2023 May 01; Vol. 8 (1), pp. e10366. Date of Electronic Publication: 2023 May 01 (Print Publication: 2024).
نوع المنشور: Journal Article
اللغة: English
بيانات الدورية: Publisher: Wiley, published in collaboration with the University of Michigan Country of Publication: United States NLM ID: 101708071 Publication Model: eCollection Cited Medium: Internet ISSN: 2379-6146 (Electronic) Linking ISSN: 23796146 NLM ISO Abbreviation: Learn Health Syst Subsets: PubMed not MEDLINE
أسماء مطبوعة: Original Publication: [Boston, MA] : Wiley, published in collaboration with the University of Michigan, [2017]-
مستخلص: Introduction: Numerous arguments have been advanced for broadly sharing de-identified, participant-level clinical trial data. However, data sharing in pragmatic clinical trials (PCTs) presents ethical challenges. While prior scholarship has described aspects of PCTs that raise distinct considerations for data sharing, there have been no reports of the experiences of those at the leading edge of data-sharing efforts for PCTs, including how these particular challenges have been navigated. To address this gap, we conducted interviews with key stakeholders, with a focus on the ethical issues presented by sharing data from PCTs.
Methods: We recruited respondents using purposive sampling to reflect the range of stakeholder groups affected by efforts to expand PCT data sharing. Through semi-structured interviews, we explored respondents' experiences and perceptions about sharing de-identified, individual-level data from PCTs. An integrated approach was used to identify and describe key themes.
Results: We conducted 40 interviews between April and September 2022. Five overarching themes emerged through analysis: (1) challenges in sharing data collected under a waiver or alteration of consent; (2) conflicting views regarding PCT patient-subject preferences for data sharing; (3) identification of respect-promoting practices beyond consent; (4) concerns about elevated risks or burdens from sharing PCT data; and (5) diverse views about the likely benefits resulting from sharing PCT data.
Conclusion: Our data indicate unresolved tensions in how to fulfill the expectation to broadly share de-identified, individual-level data from PCTs, and suggest that those promulgating and implementing data-sharing policies must be sensitive to PCT-specific considerations. Future work could inform efforts to tailor data-sharing policy and practice to reflect the challenges presented by PCTs, including sharing experiences from trials that have successfully navigated these tensions.
Competing Interests: Jeremy Sugarman is a member of Merck KGaA's Ethics Advisory Panel and Stem Cell Research Oversight Committee; a member of IQVIA's Ethics Advisory Panel; a member of Aspen Neurosciences Clinical Advisory Panel; a member of a Merck Data Monitoring Committee; and a consultant to Biogen. None of these activities are related to the material discussed in this manuscript. No other authors have any conflicts to disclose.
(© 2023 The Authors. Learning Health Systems published by Wiley Periodicals LLC on behalf of University of Michigan.)
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معلومات مُعتمدة: U24 AT009676 United States AT NCCIH NIH HHS; U24 AT010961 United States AT NCCIH NIH HHS
فهرسة مساهمة: Keywords: data sharing; ethics; individual participant data; pragmatic clinical trials
تواريخ الأحداث: Date Created: 20240122 Latest Revision: 20240210
رمز التحديث: 20240210
مُعرف محوري في PubMed: PMC10797577
DOI: 10.1002/lrh2.10366
PMID: 38249837
قاعدة البيانات: MEDLINE
الوصف
تدمد:2379-6146
DOI:10.1002/lrh2.10366