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

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.

Progress toward realizing the promise of decentralized clinical trials

“…To understand barriers to successful diverse and representative recruitment, it is critical to hear from potential participants in relevant communities. Hamm et al describe stakeholder engagement activities conducted for a decentralized trial, with the work done in a decentralized manner [ 6 ].…”