临床试验招募的成功与挑战:新研究团队的经验。

Man Hung, Amir Mohajeri, Konstantinia Almpani, Gabriel Carberry, John F Wisniewski, Kade Janes, Brooklyn Janes, Chase Hardy, Golnoush Zakeri, Ben Raymond, Heather Trinh, Jordan Bretner, Val J Cheever, Rafael Garibyan, Perry Bachstein, Frank W Licari
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引用次数: 0

摘要

参与者招募是临床试验中最具挑战性的环节之一,直接影响到研究的持续时间和结果的质量。因此,报告成功的招募策略至关重要。本研究旨在记录一个研究团队在大学进行随机临床试验期间的招募策略和经验,该试验是临床研究沉浸项目的一部分。招募工作于 2021 年 10 月至 2022 年 10 月进行。研究开始前,研究团队成员接受了首席研究员提供的有关临床试验参与者招募的正式培训。招募策略已纳入初步研究设计,并获得了机构审查委员会的批准。研究采用了多模式方法,包括直接和间接招募方法。这些策略成功地在 12 个月内实现了招生目标。在整个过程中,团队成员获得了招募设计和实施方面的宝贵知识,以及可迁移的人际关系和网络技能。当面招募是最有效和最具成本效益的策略,其次是个人推荐。主要的挑战在于如何满足参与者的空闲时间。其他研究团队在设计研究时应考虑这些招募策略。此外,本研究小组获得的知识和技能也凸显了体验式学习在研究教育中的价值。
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Successes and Challenges in Clinical Trial Recruitment: The Experience of a New Study Team.

Participant recruitment is one of the most challenging aspects of a clinical trial, directly impacting both the study's duration and the quality of its results. Therefore, reporting successful recruitment strategies is crucial. This study aimed to document the recruitment tactics and experiences of a research team during a university-based randomized clinical trial, conducted as part of a clinical research immersion program. Recruitment took place from October 2021 to October 2022. Before the study commenced, study team members received formal training in clinical trial participant recruitment from the Principal Investigator. The recruitment strategies were integrated into initial study design, which was approved by the Institutional Review Board. A multimodal approach was employed, incorporating both direct and indirect recruitment methods. These strategies successfully met the enrollment target within the twelve-month period. Throughout the process, team members acquired valuable knowledge in recruitment design and implementation, along with transferable interpersonal and networking skills. In-person recruitment was the most efficient and cost-effective strategy, followed by personal referrals. The primary challenge was accommodating participants' availability. Other study teams should consider these recruitment strategies during their study designs. Additionally, the knowledge and skills gained by this study team underscore the value of experiential learning in research education.

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