دورية أكاديمية
أعرض في EDS

Post-trial responsibilities in pragmatic clinical trials: Fulfilling the promise of research to drive real-world change.

التفاصيل البيبلوغرافية
العنوان: Post-trial responsibilities in pragmatic clinical trials: Fulfilling the promise of research to drive real-world change.
المؤلفون: Morain SR; Berman Institute of Bioethics Johns Hopkins University Baltimore Maryland USA.; Department of Health Policy & Management Bloomberg School of Public Health Baltimore Maryland USA., O'Rourke PP; Boston MA USA., Ali J; Berman Institute of Bioethics Johns Hopkins University Baltimore Maryland USA.; Department of International Health Bloomberg School of Public Health Baltimore Maryland USA., Rahimzadeh V; Center for Medical Ethics and Health Policy Baylor College of Medicine Houston Texas USA., Check DK; Department of Population Health Sciences Duke University School of Medicine Durham North Carolina USA., Bosworth HB; Department of Population Health Sciences Duke University School of Medicine Durham North Carolina USA., Sugarman J; Berman Institute of Bioethics Johns Hopkins University Baltimore Maryland USA.; Department of Health Policy & Management Bloomberg School of Public Health Baltimore Maryland USA.; Department of Medicine Johns Hopkins University School of Medicine Baltimore Maryland USA.
المصدر: Learning health systems [Learn Health Syst] 2024 Mar 06; Vol. 8 (3), pp. e10413. Date of Electronic Publication: 2024 Mar 06 (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: While considerable scholarship has explored responsibilities owed to research participants at the conclusion of explanatory clinical trials, no guidance exists regarding responsibilities owed at the conclusion of a pragmatic clinical trial (PCT). Yet post-trial responsibilities in PCTs present distinct considerations from those emphasized in existing guidance and prior scholarship. Among these considerations include the responsibilities of the healthcare delivery systems in which PCTs are embedded, and decisions about implementation for interventions that demonstrate meaningful benefit following their integration into usual care settings-or deimplementation for those that fail to do so. In this article, we present an overview of prior scholarship and guidance on post-trial responsibilities, and then identify challenges for post-trial responsibilities for PCTs. We argue that, given one of the key rationales for PCTs is that they can facilitate uptake of their results by relevant decision-makers, there should be a presumptive default that PCT study results be incorporated into future care delivery processes. Fulfilling this responsibility will require prospective planning by researchers, healthcare delivery system leaders, institutional review boards, and sponsors, so as to ensure that the knowledge gained from PCTs does, in fact, influence real-world practice.
Competing Interests: The content is solely the responsibility of the authors and does not necessarily represent the official views of the NCCIH, NIAID, NCI, NIA, NHLBI, NINR, NIMHD, NIAMS, OBSSR, or ODP, or the NIH or its HEAL Initiative. Dr. Morain received support for this work through a Making a Difference grant from The Greenwall Foundation. 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; was a member of a Merck Data Monitoring Committee and a consultant to Biogen. None of these activities is related to the material discussed in this manuscript. The other authors have no conflicts to declare.
(© 2024 The Authors. Learning Health Systems published by Wiley Periodicals LLC on behalf of University of Michigan.)
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فهرسة مساهمة: Keywords: post‐trial access; post‐trial obligations; pragmatic clinical trials; research ethics
تواريخ الأحداث: Date Created: 20240722 Latest Revision: 20240723
رمز التحديث: 20240723
مُعرف محوري في PubMed: PMC11257052
DOI: 10.1002/lrh2.10413
PMID: 39036536
قاعدة البيانات: MEDLINE
الوصف
تدمد:2379-6146
DOI:10.1002/lrh2.10413