Principal Investigators' Perceptions on Factors Associated with Successful Recruitment in Clinical Trials.

Betina Idnay, Alex Butler, Yilu Fang, Ziran Li, Junghwan Lee, Casey Ta, Cong Liu, Brenda Ruotolo, Chi Yuan, Huanyao Chen, George Hripcsak, Elaine Larson, Chunhua Weng
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Abstract

Participant recruitment continues to be a challenge to the success of randomized controlled trials, resulting in increased costs, extended trial timelines and delayed treatment availability. Literature provides evidence that study design features (e.g., trial phase, study site involvement) and trial sponsor are significantly associated with recruitment success. Principal investigators oversee the conduct of clinical trials, including recruitment. Through a cross-sectional survey and a thematic analysis of free-text responses, we assessed the perceptions of sixteen principal investigators regarding success factors for participant recruitment. Study site involvement and funding source do not necessarily make recruitment easier or more challenging from the perspective of the principal investigators. The most commonly used recruitment strategies are also the most effort inefficient (e.g., in-person recruitment, reviewing the electronic medical records for prescreening). Finally, we recommended actionable steps, such as improving staff support and leveraging informatics-driven approaches, to allow clinical researchers to enhance participant recruitment.

主要研究人员对临床试验成功招募相关因素的看法。
参与者招募仍然是随机对照试验成功与否的一个挑战,会导致成本增加、试验时间延长和治疗延迟。有文献证明,研究设计特点(如试验阶段、研究机构参与)和试验发起人与招募成功与否密切相关。主要研究者负责监督临床试验的进行,包括招募。通过横向调查和对自由文本回答的主题分析,我们评估了 16 位主要研究者对参与者招募成功因素的看法。从主要研究者的角度来看,研究机构的参与和资金来源并不一定会使招募工作变得更容易或更具挑战性。最常用的招募策略也是最费力低效的(如亲自招募、审查电子病历进行预选)。最后,我们建议了一些可操作的步骤,如改善员工支持和利用信息学驱动的方法,使临床研究人员能够加强参与者招募工作。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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