Alarcón Garavito Germán Andrés, Gilchrist Katie, Ciurtin Coziana, Khanna Sanjay, Chambers Pinkie, McNally Nick, Merivale Edward, Carr Edi, Yu Rosamund, Vindrola-Padros Cecilia
Rapid Research Evaluation and Appraisal Lab (RREAL), University College London, London, UK.
University College London Hospitals NHS Foundation Trust (UCLH), London, UK.
Trials. 2025 Feb 22;26(1):65. doi: 10.1186/s13063-025-08769-y.
Clinical trials are essential to the development of healthcare innovations that advance life expectancy and improve quality of life. However, there exists a pronounced disparity in ethnic representation among trial participants. This imbalance, particularly in relation to minority ethnic groups, can lead to a limited understanding of how therapies affect diverse populations. The present systematic literature review (SLR) aims to identify the factors that both hinder and facilitate the participation of minority ethnic groups in clinical trials.
This review involved a systematic search of keywords across four databases: Web of Science, PubMed, CINAHL Plus and The Cochrane Library. The review was not restricted by language or study site; however, the date of publication was limited between 1st January 2017 and 1st October 2022. Studies discussing or outlining the involvement of minority ethnic groups in clinical trials, and those outlining inclusive recruitment and participation procedures were targeted.
A total of 43 articles were included in the review. Of these, 36 articles were from the United States (US), 20 articles reported on oncology trials and 39 articles reported information from the patient's perspective. Reported barriers included a lack of researchers from minority ethnic groups implementing and conducting clinical research, inadequate funding for clinical trial efforts in geographical areas serving minority populations and a lack of awareness and education among research staff regarding which underrepresented groups to target for recruitment and the strategies to employ in reaching out to them. Several recommendations were suggested by the articles included in the review to address these barriers. Prominently, the use of patient navigators or community liaison roles was highly recommended as a way of supporting patients through the research recruitment process. The articles also highlighted the benefits of translating study materials and interventions into multiple languages and actively involving diverse communities in the development of health education materials. Lastly, leveraging technologies to address socioeconomic barriers, such as the use of virtual approaches to avoid lengthy travel, may also help to improve diversity in trials.
Ensuring representation of minority ethnic groups in clinical trials is critical to developing therapies with generalisable efficacies. While progress has been made in enhancing outreach of wider racial groups and fortifying educational resources, there remains a pressing need to delve deeper into the obstacles impeding the recruitment of a diverse participant base, particularly in regions outside the US, where relevant studies are scarce.
The review protocol was registered on PROSPERO (CRD42022368106) (1).
临床试验对于推动预期寿命延长和生活质量改善的医疗创新发展至关重要。然而,试验参与者的种族代表性存在显著差异。这种不平衡,尤其是与少数族裔群体相关的不平衡,可能导致对治疗方法如何影响不同人群的理解有限。本系统文献综述(SLR)旨在确定阻碍和促进少数族裔群体参与临床试验的因素。
本综述涉及在四个数据库中系统搜索关键词:科学网、PubMed、CINAHL Plus和考克兰图书馆。综述不受语言或研究地点限制;然而,出版日期限制在2017年1月1日至2022年10月1日之间。针对讨论或概述少数族裔群体参与临床试验的研究,以及概述包容性招募和参与程序的研究。
综述共纳入43篇文章。其中,36篇文章来自美国,20篇文章报道了肿瘤学试验,39篇文章从患者角度报道了信息。报告的障碍包括缺乏少数族裔研究人员实施和开展临床研究、在为少数族裔人口服务的地理区域进行临床试验的资金不足,以及研究人员对哪些代表性不足的群体进行招募目标不明确以及在接触这些群体时应采用的策略缺乏认识和教育。综述中纳入的文章提出了几项建议来解决这些障碍。突出的是,强烈建议使用患者导航员或社区联络角色,作为在研究招募过程中支持患者的一种方式。文章还强调了将研究材料和干预措施翻译成多种语言以及让不同社区积极参与健康教育材料开发的好处。最后,利用技术解决社会经济障碍,如使用虚拟方法避免长途旅行,也可能有助于提高试验的多样性。
确保少数族裔群体在临床试验中的代表性对于开发具有普遍疗效的治疗方法至关重要。虽然在扩大更广泛种族群体的宣传范围和加强教育资源方面已经取得了进展,但仍迫切需要更深入地探究阻碍招募多样化参与者群体的障碍,特别是在美国以外相关研究稀缺的地区。
综述方案已在PROSPERO(CRD42022368106)上注册(1)。