Site engagement for multi-site clinical trials
Site engagement for multi-site clinical trials
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DOI：
10.1016/j.conctc.2020.100608
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发表时间：
2020-09-01
影响因子：
1.5
通讯作者：
Mullins, C. Daniel
中科院分区：
文献类型：
--
作者：
Goodlett, Dana;Hung, Anna;Mullins, C. Daniel
多地点临床试验在医疗实践中至关重要，有助于推动可靠和可推广的知识，以推进医疗。尽管多地点试验的成功很大程度上取决于当地的临床医生和地点研究团队，但地点团队参与的最佳实践，或“地点参与”，尚未得到广泛讨论。地点参与的核心是将地点包括在临床试验的规划和实施中，以促进试验的登记、依从性和对当地环境的适用性。以RadComp试验（一项纵向、多地点临床试验）中的一个案例为例，在三个主要研究阶段提供了新的地点参与实践。在规划阶段，现场参与通过积极获取现场特定流程的信息和对试验设计的反馈来建立伙伴关系和承诺。在实施阶段，持续的参与鼓励双向沟通，并促进学习网络，以提高网站的性能。在传播阶段，利用站点和社区伙伴关系来创建本地设计的传播计划，以实现更广泛的科学覆盖和影响。本文讨论的现场参与实践可以复制或塑造应用于其他多地点临床试验。
Multi-site clinical trials are essential within medical practice to help drive reliable and generalizable knowledge on advancing medical treatments. Although the success of multi-site trials is significantly dependent on local clinician and site research teams, best practices for engagement of site teams, or "site engagement," has not been extensively discussed. Site engagement centers on including sites in the planning and implementation of clinical trials to promote trial enrollment, compliance, and applicability to local contexts. Using a case example from the RadComp Trial, a longitudinal, multi-site clinical trial, novel site engagement practices are provided across three major research phases. In the Planning Phase, site engagement builds partnerships and commitment by active elicitation of information on site specific processes and feedback on trial design. In the Conducting Phase, sustained engagement encourages bi-directional communication and facilitates learning networks for enhanced site performance. In the Dissemination Phase, site and community partnerships are leveraged to create locally designed dissemination plans for broader scientific reach and impact. Site engagement practices discussed in this paper can be replicated or molded for application in other multi-site clinical trials.