CUNY School of Public Health and Health Policy, City University of New York, 55 West 125th St., New York, NY, 10027, USA.
Division of Social Epidemiology, College of Global Public Health, New York University, 41 East 11th St, 7th Floor, New York, NY, USA.
J Racial Ethn Health Disparities. 2017 Dec;4(6):1225-1236. doi: 10.1007/s40615-016-0332-y. Epub 2017 Feb 7.
Randomized controlled trials (RCTs) are the gold standard within evidence-based research. Low participant accrual rates, especially of underrepresented groups (e.g., racial-ethnic minorities), may jeopardize clinical studies' viability and strength of findings. Research has begun to unweave clinical trial mechanics, including the roles of clinical research coordinators, to improve trial participation rates.
Two semi-structured focus groups were conducted with a purposive sample of 29 clinical research coordinators (CRCs) at consecutive international stroke conferences in 2013 and 2014 to gain in-depth understanding of coordinator-level barriers to racial-ethnic minority recruitment and retention into neurological trials. Coded transcripts were used to create themes to define concepts, identify associations, summarize findings, and posit explanations.
Barriers related to translation, literacy, family composition, and severity of medical diagnosis were identified. Potential strategies included a focus on developing personal relationships with patients, community and patient education, centralized clinical trial administrative systems, and competency focused training and education for CRCs.
Patient level barriers to clinical trial recruitment are well documented. Less is known about barriers facing CRCs. Further identification of how and when barriers manifest and the effectiveness of strategies to improve CRCs recruitment efforts is warranted.
随机对照试验（RCTs）是循证研究的金标准。参与者招募率低，尤其是代表性不足的群体（例如，少数族裔），可能会危及临床研究的可行性和研究结果的强度。研究已经开始揭示临床试验的机制，包括临床研究协调员的角色，以提高试验参与率。
在 2013 年和 2014 年连续举行的国际卒中会议上，对 29 名临床研究协调员（CRC）进行了两次半结构式焦点小组讨论，以深入了解协调员层面在招募和保留少数民族参与神经学试验方面的障碍。对编码的转录本进行分析，以创建主题，从而定义概念、确定关联、总结研究结果并提出解释。
确定了与翻译、文化水平、家庭构成和医疗诊断严重程度相关的障碍。潜在的策略包括专注于与患者建立个人关系、社区和患者教育、集中的临床试验管理系统以及针对 CRC 的以能力为重点的培训和教育。
患者层面参与临床试验招募的障碍已有充分记录。CRC 面临的障碍则知之甚少。需要进一步确定障碍的表现形式和出现时间，以及提高 CRC 招募效果的策略的有效性。
