Memorial Sloan Kettering Cancer Center, New York, New York, USA.
Cancer. 2022 Nov 1;128(21):3860-3869. doi: 10.1002/cncr.34454. Epub 2022 Sep 15.
Racial and ethnic minorities (REMs) continue to be underrepresented in clinical trials despite the 1993 National Institutes of Health's Revitalization Act mandating the representation of women and underrepresented minority groups in clinical trials. Although Blacks represent 15% and Hispanics 13% of the cancer population, their clinical trial enrollment rates are disproportionately low at 4% to 6% and 3% to 6%, respectively. A systematic review exploring interventions aimed at improving cancer clinical trial (CCT) enrollment for REMs was conducted.
A systematic search of PubMed, Cochrane CENTRAL, and Ovid PsycINFO was conducted for English-language studies since 1993. Inclusion criteria included peer-reviewed, US-based studies with interventions aimed to recruit underrepresented minority adult patients into cancer clinical trials. REM groups were defined as Black, Hispanic, Asian, American Indian, and Native Hawaiian/other Pacific Islander.
The systematic search identified 3123 studies, of which nine met inclusion criteria. Interventions included patient navigation/coaching (n = 4), a clinical trial educational video (n = 2), institutional research infrastructure changes (n = 1), a relationship building and social marketing recruitment model (n = 1), and cultural competency training for providers (n = 1). A statistically significant improvement in accrual was shown in three of the patient navigation interventions, one of the clinical trial educational videos and an institutional research infrastructure change.
This systematic review illustrates several potential mechanisms by which to increase CCT recruitment for patients of REM backgrounds in various clinical settings. More randomized controlled trials are needed to further explore the benefits of these interventions for REMs.
尽管 1993 年美国国立卫生研究院的复兴法案要求在临床试验中代表女性和代表性不足的少数族裔群体，但少数族裔（REM）继续在临床试验中代表性不足。尽管黑人占癌症患者的 15%，西班牙裔占 13%，但他们的临床试验入组率分别低得不成比例，分别为 4%至 6%和 3%至 6%。对旨在提高 REM 癌症临床试验（CCT）入组率的干预措施进行了系统评价。
对 1993 年以来发表的英文研究进行了 PubMed、Cochrane CENTRAL 和 Ovid PsycINFO 的系统检索。纳入标准包括基于美国的、针对代表性不足的少数族裔成年患者入组癌症临床试验的干预措施的同行评审研究。REM 群体定义为黑人、西班牙裔、亚洲人、美国印第安人和夏威夷原住民/其他太平洋岛民。
系统搜索确定了 3123 项研究，其中 9 项符合纳入标准。干预措施包括患者导航/辅导（n=4）、临床试验教育视频（n=2）、机构研究基础设施变化（n=1）、建立关系和社会营销招聘模式（n=1）以及为提供者提供文化能力培训（n=1）。在三项患者导航干预措施、一项临床试验教育视频和一项机构研究基础设施变化中，入组率有统计学显著提高。
这项系统评价说明了在各种临床环境中增加 REM 背景患者 CCT 招募的几种潜在机制。需要更多的随机对照试验来进一步探讨这些干预措施对 REM 的益处。
