Barriers to Recruitment and Retention Among Underrepresented Populations in Cancer Clinical Trials: A Qualitative Study of the Perspectives of Clinical Trial Research Coordinating Staff at a Cancer Center.

IF 3.4 Q1 HEALTH POLICY & SERVICES
Journal of Healthcare Leadership Pub Date : 2024-11-01 eCollection Date: 2024-01-01 DOI:10.2147/JHL.S488426
Sumbul Yousafi, Pavani Rangachari, Margaret L Holland
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引用次数: 0

Abstract

Background: Although US research agencies have instituted peer review processes to require participant diversity in clinical trials before funding decisions are made, the underrepresentation of certain populations (eg, racial and ethnic minorities) in clinical trials remains a persistent challenge in biomedical research. This issue has the potential to affect the generalizability of findings and impede efforts to ensure the provision of high-quality healthcare across all populations. In this study, we examined barriers to the recruitment and retention of underrepresented populations in cancer clinical trials from the perspective of research coordinating staff.

Methods: Semi-structured interviews were conducted at a US-based academic cancer center and included 6 patient-facing staff (clinical research coordinators) and 6 non-patient-facing staff (regulatory and financial specialists). Interview data were subjected to thematic analysis. To provide additional organizational context, descriptive data were obtained on the characteristics of clinical trials undertaken at the cancer center.

Results: The following themes emerged from the staff interviews: 1) absence of a consistent structure for decision-making and problem-solving related to recruitment and retention, 2) staff shortages, 3) administrative burden, and 4) lack of resources. In addition, descriptive data revealed that nearly half the trials, 64/134 (48%), offered informed consent only in English, and only 3/134 (2%) offered participant incentives or reimbursement (eg, for transportation). These interrelated organizational issues were indicative of inadequate systems for ensuring diverse and equitable representation in cancer clinical trials.

Conclusion: Results indicate that overcoming barriers to underrepresentation may require dedicated support from sponsoring agencies in the form of evidence-based guidelines, learning collaboratives to facilitate implementation, technical support, resources, and oversight. For progress to be made therefore, both sponsors and cancer centers may need to assume joint responsibility for the implementation of effective systems for ensuring diverse and equitable representation in cancer clinical trials.

癌症临床试验中代表性不足人群的招募和保留障碍:一项关于癌症中心临床试验研究协调人员观点的定性研究。
背景:尽管美国的研究机构已经制定了同行评审程序,要求临床试验的参与者在做出资助决定前必须具有多样性,但某些人群(如少数种族和民族)在临床试验中的代表性不足仍然是生物医学研究中一个长期存在的挑战。这一问题有可能影响研究结果的推广性,并阻碍确保为所有人群提供高质量医疗服务的努力。在本研究中,我们从研究协调人员的角度出发,探讨了在癌症临床试验中招募和留住代表性不足人群的障碍:我们在美国一家学术癌症中心进行了半结构化访谈,访谈对象包括 6 名面向患者的工作人员(临床研究协调员)和 6 名非面向患者的工作人员(监管和财务专家)。对访谈数据进行了主题分析。为了提供更多的组织背景信息,还获得了关于该癌症中心开展的临床试验特点的描述性数据:从员工访谈中得出以下主题:1) 缺乏与招募和留用相关的决策和问题解决的统一架构;2) 人员短缺;3) 行政负担;4) 资源匮乏。此外,描述性数据显示,近一半的试验(64/134,占 48%)仅以英语提供知情同意书,仅有 3/134(占 2%)为参与者提供奖励或报销(如交通费)。这些相互关联的组织问题表明,在癌症临床试验中确保多样化和公平代表性的系统并不完善:结果表明,要克服代表性不足的障碍,可能需要赞助机构以循证指南、促进实施的学习合作、技术支持、资源和监督等形式提供专门支持。因此,要想取得进展,发起机构和癌症中心可能需要共同承担责任,实施有效的制度,确保癌症临床试验中的多元化和公平代表性。
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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来源期刊
Journal of Healthcare Leadership
Journal of Healthcare Leadership HEALTH POLICY & SERVICES-
CiteScore
5.40
自引率
2.30%
发文量
27
审稿时长
16 weeks
期刊介绍: Efficient and successful modern healthcare depends on a growing group of professionals working together as an interdisciplinary team. However, many forces shape the delivery of healthcare; changes are being driven by the markets, transformations in concepts of health and wellbeing, technology and research and discovery. Dynamic leadership will guide these necessary transformations. The Journal of Healthcare Leadership is an international, peer-reviewed, open access journal focusing on leadership for the healthcare professions. The publication strives to amalgamate current and future healthcare professionals and managers by providing key insights into leadership progress and challenges to improve patient care. The journal aspires to inform key decision makers and those professionals with ambitions of leadership and management; it seeks to connect professionals who are engaged in similar endeavours and to provide wisdom from those working in other industries. Senior and trainee doctors, nurses and allied healthcare professionals, medical students, healthcare managers and allied leaders are invited to contribute to this publication
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