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The ACTIV-6 Stakeholder Advisory Committee: a model for virtual engagement in decentralized clinical trials

Megan E. Hamm, Jonathan Arnold, Josh Denson, Talethia Edwards,Greg Merritt,Matthew McCarthy,Danielle Nelson, Kirk T. Phillips,Florence Thicklin, Andrew Vasey,Kathleen McTigue

JOURNAL OF CLINICAL AND TRANSLATIONAL SCIENCE(2023)

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Abstract
Introduction:Engaging patients, caregivers, and other stakeholders to help guide the research process is a cornerstone of patient-centered research. Lived expertise may help ensure the relevance of research questions, promote practices that are satisfactory to research participants, improve transparency, and assist with disseminating findings.Methods:Traditionally engagement has been conducted face-to-face in the local communities in which research operates. Decentralized platform trials pose new challenges for the practice of engagement. We used a remote model for stakeholder engagement, relying on Zoom meetings and blog communications.Results:Here we describe the approach used for research partnership with patients, caregivers, and clinicians in the planning and oversight of the ACTIV-6 trial and the impact of this work. We also present suggestions for future remote engagement.Conclusions:The ACTIV-6 experience may inform proposed strategies for future engagement in decentralized trials.
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Key words
Patient participation,community participation,stakeholder participation,engagement,research design
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