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. 2023 Nov 20;7(1):e264.
doi: 10.1017/cts.2023.671. eCollection 2023.

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

Megan E Hamm  1 , Jonathan Arnold  1 , Josh Denson  2 , Talethia Edwards  3 , Greg Merritt  4 , Matthew McCarthy  5 , Danielle Nelson  6 , Kirk T Phillips  7 , Florence Thicklin  8 , Andrew Vasey  9 , Kathleen McTigue  1
Affiliations

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

Megan E Hamm et al. J Clin Transl Sci. .

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.

Keywords: Patient participation; community participation; engagement; research design; stakeholder participation.

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Conflict of interest statement

No authors have any conflicts of interest to disclose.

Figures

Figure 1.
Figure 1.
Diagram of ACTIV-6 SAC stakeholder engagement activities and communications.
See this image and copyright information in PMC

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