Yousafi Sumbul, Rangachari Pavani, Holland Margaret L
Department of Population Health and Leadership, University of New Haven, West Haven, CT, USA.
J Healthc Leadersh. 2024 Nov 1;16:427-441. doi: 10.2147/JHL.S488426. eCollection 2024.
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.
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.
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.
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.
尽管美国研究机构已制定同行评审程序，要求在做出资助决定前确保临床试验中的参与者具有多样性，但某些人群（如少数族裔）在临床试验中的代表性不足仍是生物医学研究中持续存在的挑战。这个问题可能会影响研究结果的普遍性，并阻碍为所有人群提供高质量医疗保健的努力。在本研究中，我们从研究协调人员的角度研究了癌症临床试验中代表性不足人群招募和留用的障碍。
在美国一家学术癌症中心进行了半结构化访谈，包括6名面向患者的工作人员（临床研究协调员）和6名不面向患者的工作人员（监管和财务专家）。访谈数据进行了主题分析。为提供更多组织背景信息，获取了该癌症中心开展的临床试验特征的描述性数据。
工作人员访谈中出现了以下主题：1）缺乏与招募和留用相关的决策和解决问题的一致结构，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，即64/134（48%）仅提供英文的知情同意书，只有3/134（2%）提供参与者激励或报销（如交通费用）。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存在不足。
结果表明，克服代表性不足的障碍可能需要资助机构以循证指南、促进实施的学习协作、技术支持、资源和监督等形式提供专门支持。因此，要取得进展，资助者和癌症中心可能都需要共同承担责任，实施有效的系统，以确保癌症临床试验中的多样化和公平代表性。
