ACTIV-6 利益相关者咨询委员会：去中心化临床试验中虚拟参与的一个范例。
The ACTIV-6 Stakeholder Advisory Committee: a model for virtual engagement in decentralized clinical trials.
作者信息
Hamm Megan E, Arnold Jonathan, Denson Josh, Edwards Talethia, Merritt Greg, McCarthy Matthew, Nelson Danielle, Phillips Kirk T, Thicklin Florence, Vasey Andrew, McTigue Kathleen
机构信息
Division of General Internal Medicine, University of Pittsburgh, Pittsburgh, PA, USA.
Section of Pulmonary, Critical Care, and Environmental Medicine, Tulane University School of Medicine, New Orleans, LA, USA.
出版信息
J Clin Transl Sci. 2023 Nov 20;7(1):e264. doi: 10.1017/cts.2023.671. eCollection 2023.
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.
引言
让患者、护理人员和其他利益相关者参与进来，以帮助指导研究过程，是患者中心研究的基石。实际经验可能有助于确保研究问题的相关性，推广令研究参与者满意的做法，提高透明度，并协助传播研究结果。
方法
传统上，参与活动是在研究开展所在的当地社区面对面进行的。分散式平台试验给参与实践带来了新的挑战。我们采用了一种远程模式进行利益相关者参与，依靠Zoom会议和博客交流。
结果
在此，我们描述了在ACTIV-6试验的规划和监督中与患者、护理人员和临床医生建立研究伙伴关系所采用的方法以及这项工作的影响。我们还提出了未来远程参与的建议。
结论
ACTIV-6的经验可能为未来参与分散式试验的拟议策略提供参考。
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