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当临床试验提前结束时,把参与者和研究伙伴放在首位。

Putting participants and study partners FIRST when clinical trials end early.

机构信息

Department of Medical Ethics and Health Policy, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA.

Alzheimer's Therapeutic Research Institute, University of Southern California, San Diego, CA, USA.

出版信息

Alzheimers Dement. 2022 Dec;18(12):2736-2746. doi: 10.1002/alz.12732. Epub 2022 Aug 2.

Abstract

Between 2018 and 2019, multiple clinical trials ended earlier than planned, resulting in calls to improve communication with and support for participants and their study partners ("dyads"). The multidisciplinary Participant Follow-Up Improvement in Research Studies and Trials (Participant FIRST) Work Group met throughout 2021. Its goals were to identify best practices for communicating with and supporting dyads affected by early trial stoppage. The Participant FIRST Work Group identified 17 key recommendations spanning the pre-trial, mid-trial, and post-trial periods. These focus on prospectively allocating sufficient resources for orderly closeout; developing dyad-centered communication plans; helping dyads build and maintain support networks; and, if a trial stops, informing dyads rapidly. Participants and study partners invest time, effort, and hope in their research participation. The research community should take intentional steps toward better communicating with and supporting participants when clinical trials end early. The Participant FIRST recommendations are a practical guide for embarking on that journey.

摘要

在 2018 年至 2019 年期间,多项临床试验提前结束,这促使人们呼吁改善与参与者及其研究伙伴(“二人组”)的沟通和支持。多学科参与者后续研究和试验改进(Participant FIRST)工作组在 2021 年全年举行了会议。其目标是确定与受提前试验停止影响的二人组进行沟通和提供支持的最佳实践。Participant FIRST 工作组确定了 17 项关键建议,涵盖了试验前、试验中和试验后期间。这些建议重点在于为有序结束预先分配足够的资源;制定以二人组为中心的沟通计划;帮助二人组建立和维持支持网络;以及如果试验停止,迅速通知二人组。参与者和研究伙伴在他们的研究参与中投入了时间、精力和希望。当临床试验提前结束时,研究界应该采取有意识的步骤,更好地与参与者进行沟通并为其提供支持。Participant FIRST 的建议是踏上这一旅程的实用指南。

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