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Participants as Partners in Decentralized Clinical Trials
Paul A Harris1,2, Alex C Cheng1,2
1Vanderbilt Institute for Clinical and Translational Research, Nashville.
Abstract:
AbstractDecentralized clinical trials (DCTs), meaning those trials in which activities are conducted outside of hospital or clinic settings, offer many advantages over traditional clinical trials and, when properly operationalized, provide unique benefits to researchers, participants, and society. The ability of individuals to participate remotely from their homes adds convenience, but, more importantly, democratizes access to trials that would otherwise be limited by geographic constraints. As personal interactions with participants are diminished in DCTs, trialists must be intentional when strategizing recruitment, retention, and return of value for participants. Engaging clinical trial participants as partners in DCTs requires researchers to consider participant priorities at each stage of the trial. This article highlights technical and procedural considerations needed to support DCTs and identifies areas for trial innovation. By making DCTs and technology platforms participant centric and continuing to advance opportunities for innovation, researchers may accelerate scientific discovery, help participants feel their contributions are meaningful, and foster long-term trust in the biomedical research process.See also in NEJM: As-Needed Albuterol-Budesonide in Mild Asthma See also in NEJM: Your Combination Asthma Inhaler - Don't Leave Home without It!
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