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

dc.contributor.author

Morain, Stephanie R

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O'Rourke, P Pearl

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Ali, Joseph

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Rahimzadeh, Vasiliki

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Check, Devon K

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Bosworth, Hayden B

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Sugarman, Jeremy

dc.date.accessioned

2024-06-27T20:08:53Z

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2024-06-27T20:08:53Z

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2024-01-01

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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.

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2379-6146

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2379-6146

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https://hdl.handle.net/10161/31222

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en

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Wiley

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Learning Health Systems

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10.1002/lrh2.10413

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https://creativecommons.org/licenses/by-nc/4.0

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post-trial access

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post-trial obligations

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pragmatic clinical trials

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research ethics

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

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Journal article

duke.contributor.orcid

Check, Devon K|0000-0002-0673-879X|0000-0003-0872-5527

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Bosworth, Hayden B|0000-0001-6188-9825

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Duke

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School of Medicine

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Basic Science Departments

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Clinical Science Departments

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Institutes and Centers

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Medicine

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Psychiatry & Behavioral Sciences

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Medicine, General Internal Medicine

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Duke Cancer Institute

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Duke Clinical Research Institute

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University Initiatives & Academic Support Units

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Center for the Study of Aging and Human Development

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Initiatives

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Duke Science & Society

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Population Health Sciences

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Duke Innovation & Entrepreneurship

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Psychiatry & Behavioral Sciences, Behavioral Medicine & Neurosciences

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Duke-Margolis Institute for Health Policy

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