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.

中文翻译：

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当临床试验提前结束时，将参与者和研究伙伴放在首位

2018 年至 2019 年期间，多项临床试验比计划提前结束，导致呼吁改善与参与者及其研究伙伴（“二元组”）的沟通和支持。研究和试验中的多学科参与者跟进改进（参与者优先）工作组在整个 2021 年举行了会议。其目标是确定与受早期试验停止影响的二元组进行沟通和支持的最佳实践。参与者 FIRST 工作组确定了 17 项关键建议，涵盖了预审、审中和审后阶段。这些重点是为有序收尾前瞻性地分配足够的资源；制定以二元组为中心的沟通计划；帮助 dyads 建立和维护支持网络；并且，如果试验停止，则迅速通知 dyads。参与者和研究伙伴投入时间、精力、并希望他们的研究参与。当临床试验提前结束时，研究界应该采取有意识的步骤，更好地与参与者沟通并提供支持。Participant FIRST 建议是踏上这一旅程的实用指南。