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《研究参与手册的创新发展:提高黑人个体参与物质使用障碍临床试验的招募与留存率的策略》

Innovative Development of Research Engagement Manual: Strategies to Enhance Recruitment and Retention of Black Individuals in Clinical Trials for Substance Use Disorders.

作者信息

Obel Geoffrey, Harris-Trimiar DeWanda, Elmore Joshua S, Mayes Taryn L, Mays Adrienne, Casey-Willingham Angela, Vasu Srividya, Shoptaw Steven, Trivedi Madhukar H

机构信息

Department of Preventative Medicine and Population Health, UT Tyler Health Science Center, Tyler, Texas, USA.

North Central Texas Council of Governments, Arlington, Texas, USA.

出版信息

Health Equity. 2025 Aug 22;9(1):387-396. doi: 10.1177/24731242251362181. eCollection 2025.

Abstract

BACKGROUND

The participation of Black individuals in clinical trials remains lower than that of other racial and ethnic groups. Substance abuse adds additional barriers to recruitment and retention. While significant attention has been devoted to identifying barriers to recruitment/retention, efforts have been largely unsuccessful in increasing the participation of Black individuals in clinical trials. This article details Phase 1 efforts to develop sustainable strategies to increase enrollment/recruitment of Black participants in clinical trials through an Innovative Development of Research Engagement Manual.

METHODS

Phase 1 involved a literature review and the establishment of an Expert Diversity Advisory Board, which identified barriers to Black individual participation in substance use disorder (SUD) research. Identified barriers included lack of awareness of research, mistrust, lack of comfort with research, lack of information, and time/resource constraints. Focus groups were conducted to assess the importance of the identified factors in 61 Black participants with SUD history.

RESULTS

Among the focus group participants, 37.7% indicated mistrust, 45.9% indicated a lack of knowledge, and 27.9% stated safety concerns as reasons for not engaging with researchers. They considered compensation, research benefits, study duration, privacy, safety, and side effects as vital information that informed their decisions on clinical trial participation. The focus groups identified financial incentives, potential treatment options, and potential for improved awareness about substance abuse treatment as factors that determine retention in a study.

CONCLUSION

With barriers identified, future efforts will focus on qualitative assessments of focus group material and developing and evaluating the manual.

摘要

背景

黑人个体参与临床试验的比例仍低于其他种族和族裔群体。药物滥用给招募和留住参与者增加了额外障碍。尽管人们已投入大量精力来确定招募/留住参与者的障碍,但在提高黑人个体参与临床试验方面的努力大多未成功。本文详细介绍了第一阶段的工作,即通过《研究参与手册创新发展》制定可持续战略,以增加黑人参与者在临床试验中的入组/招募人数。

方法

第一阶段包括文献综述和设立专家多样性咨询委员会,该委员会确定了黑人个体参与物质使用障碍(SUD)研究的障碍。确定的障碍包括对研究缺乏认识、不信任、对研究不自在、信息不足以及时间/资源限制。对61名有SUD病史的黑人参与者进行了焦点小组讨论,以评估所确定因素的重要性。

结果

在焦点小组参与者中,37.7%表示不信任,45.9%表示缺乏知识,27.9%表示安全担忧是不与研究人员接触的原因。他们认为补偿、研究益处、研究持续时间、隐私、安全和副作用是影响他们参与临床试验决策的重要信息。焦点小组确定经济激励、潜在治疗选择以及提高对药物滥用治疗认识的可能性是决定留在研究中的因素。

结论

在确定障碍后,未来的努力将集中在对焦点小组材料进行定性评估以及编写和评估该手册。

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