Johnson Davalynn A, Joosten Yvonne A, Wilkins Consuelo H, Shibao Cyndya A
Department of Medicine, Division of Clinical Pharmacology, Vanderbilt University School of Medicine, Nashville, Tennessee, USA.
Department of General Internal Medicine and Public Health, Vanderbilt University School of Medicine, Nashville, Tennessee, USA.
Clin Transl Sci. 2015 Aug;8(4):388-90. doi: 10.1111/cts.12264. Epub 2015 Mar 9.
This brief report examines how the use of community engagement principles and approaches enhanced clinical trial recruitment and retention. The Community-Engaged Research Core (CERC), a CTSA-supported resource designed to facilitate community involvement in clinical and translational research, was consulted to provide assistance with the implementation of the clinical trial, and specifically to enhance participation of the target population-African American women. CERC's key recommendations included: (1) convene a Community Engagement Studio, (2) redesign the recruitment advertisement, (3) simplify the language used to explain the scope of the study, and (4) provide transportation for participants. As a result of these interventions, a comprehensive strategy to recruit, enroll, and retain participants was formulated. After implementation of the plan by the study team, enrollment increased 78% and recruitment goals were met 16 months ahead of schedule. Participant retention and study drug adherence was 100%. We conclude that community engagement is essential to the development of an effective multifaceted plan to improve recruitment of underrepresented groups in clinical trials.
本简要报告探讨了社区参与原则和方法的运用如何促进临床试验的招募和留存。咨询了由临床与转化科学奖(CTSA)资助的社区参与研究核心(CERC),该资源旨在促进社区参与临床和转化研究,以协助开展该临床试验,特别是提高目标人群——非裔美国女性的参与度。CERC的关键建议包括:(1)召开社区参与工作室会议,(2)重新设计招募广告,(3)简化用于解释研究范围的语言,以及(4)为参与者提供交通。由于这些干预措施,制定了一项招募、登记和留存参与者的综合策略。在研究团队实施该计划后,入组人数增加了78%,招募目标提前16个月实现。参与者留存率和研究药物依从率均为100%。我们得出结论,社区参与对于制定有效的多方面计划以改善临床试验中代表性不足群体的招募至关重要。