Santacroce Sheila Judge, Beauchemin Melissa P, Pelletier Wendy, Robles Joanna M, Ruiz Jenny, Blazin Lindsay J, Aristizabal Paula, Orjuela-Grimm Manuela, Hall Anurekha G, Kahn Justine, Kline Cassie, Seif Alix E, Velez Maria C, Winestone Lena E
University of North Carolina at Chapel Hill School of Nursing, Chapel Hill, North Carolina, USA.
Columbia University Mailman School of Nursing, New York, New York, USA.
Pediatr Blood Cancer. 2024 Nov;71(11):e31321. doi: 10.1002/pbc.31321. Epub 2024 Sep 5.
Increasing representation in clinical trials is a priority for the National Cancer Institute and Children's Oncology Group (COG). Our survey of COG-affiliated institutions revealed that many sites have insufficient processes and resources to enroll children whose parents use languages other than English (LOE). We describe reported barriers and facilitators to enrolling children in clinical trials when parents use LOE and propose opportunities for improvement.
We sent a 20-item survey to COG-affiliated institutions. Five items allowed respondents to expand on replies to questions about (a) local institutional review board (IRB) requirements regarding translation of consent documents, (b) contributors to provider discomfort consenting parents who use LOE, (c) available language services and resources, and (d) barriers to enrolling children whose parents use LOE or offer ideas about approaches to improvements. Two pairs of researchers independently coded free-text responses and compared results for concordance.
A total of 139 (N = 230; 60%) institutions returned the survey. Respondents were mainly physician principal investigators (n = 79/139; 57%) at the United States sites (n = 118/139; 85%) serving less than 100 newly diagnosed children per year (n = 99/139, 71%). They described challenges at multiple levels. Proposed approaches to improvements included centralized provision of translated materials and video educational materials in various languages, and collaborating with IRBs on regulatory processes that protect families and facilitate equitable clinical trial access.
Clinical trial consortia, such as COG, face challenges in enrolling representative samples. Further research is required to design and implement multilevel interventions to ensure equitable access for all, regardless of language used, and mitigate disparate research participation.
提高临床试验中（受试者的）代表性是美国国立癌症研究所和儿童肿瘤学组（COG）的一项优先任务。我们对COG附属机构的调查显示，许多机构在招募父母使用非英语语言（LOE）的儿童时，流程和资源不足。我们描述了在父母使用LOE时招募儿童参加临床试验所报告的障碍和促进因素，并提出了改进的机会。
我们向COG附属机构发送了一份包含20个条目的调查问卷。其中5个条目允许受访者详细阐述对以下问题的回答：（a）当地机构审查委员会（IRB）对同意书翻译的要求；（b）导致医疗服务提供者在为使用LOE的父母提供同意书时感到不适的因素；（c）可用的语言服务和资源；（d）招募父母使用LOE的儿童的障碍或提出改进方法的想法。两对研究人员独立对自由文本回复进行编码，并比较结果的一致性。
共有139家机构（N = 230；60%）回复了调查。受访者主要是美国机构（n = 118/139；85%）的医师主要研究者（n = 79/139；57%），这些机构每年服务的新诊断儿童少于100名（n = 99/139，71%）。他们描述了多个层面的挑战。提出的改进方法包括集中提供多种语言的翻译材料和视频教育材料，以及与IRB合作开展保护家庭并促进公平临床试验准入的监管流程。
像COG这样的临床试验联盟在招募具有代表性的样本方面面临挑战。需要进一步开展研究，以设计和实施多层次干预措施，确保所有人无论使用何种语言都能公平参与，并减少研究参与方面的差异。
