Idnay Betina, Butler Alex, Fang Yilu, Li Ziran, Lee Junghwan, Ta Casey, Liu Cong, Ruotolo Brenda, Yuan Chi, Chen Huanyao, Hripcsak George, Larson Elaine, Weng Chunhua
Department of Biomedical Informatics.
Institutional Review Board for Human Subject Research.
AMIA Jt Summits Transl Sci Proc. 2023 Jun 16;2023:281-290. eCollection 2023.
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.
受试者招募仍然是随机对照试验取得成功的一项挑战，这导致成本增加、试验时间表延长以及治疗可及性延迟。文献表明，研究设计特征（如试验阶段、研究地点参与情况）和试验申办者与招募成功显著相关。主要研究者负责监督临床试验的开展，包括招募工作。通过横断面调查和对自由文本回复的主题分析，我们评估了16位主要研究者对受试者招募成功因素的看法。从主要研究者的角度来看，研究地点的参与情况和资金来源并不一定会使招募工作更容易或更具挑战性。最常用的招募策略也是效率最低的（如现场招募、查阅电子病历进行预筛选）。最后，我们推荐了一些可行的措施，如改善工作人员支持和利用信息学驱动的方法，以使临床研究人员能够加强受试者招募工作。
