Department of Surgery, Division of Urology, The University of Texas Medical Branch, 301 University Blvd, Galveston, TX, 77555, USA.
Department of Molecular and Cellular Biology, Dan L. Duncan Cancer Center, Advanced Technology Core, Alkek Center for Molecular Discovery, Baylor College of Medicine, Houston, TX, USA.
Cancer Causes Control. 2022 Aug;33(8):1071-1081. doi: 10.1007/s10552-022-01593-8. Epub 2022 Jun 14.
To systematically review the literature to investigate racial disparities among bladder cancer clinical trial enrollees.
A systematic review was conducted using Ovid, MEDLINE® to identify clinical trials between 1970 and 2020. Articles were reviewed and were included if they assessed race in their outcomes reporting among bladder cancer patients enrolled in clinical trials. The review was conducted in accordance with the PRISMA statement.
We identified 544 clinical trials meeting our initial search criteria, with only 24 (4.4%) studies reporting racial demographic data. Enrollees were largely Caucasian (81-98%), with a strikingly small proportion of enrolled patients consisting of African-Americans (2-8%) and Hispanics (2-5%). Only one of the studies reported results on the efficacy and safety/tolerability of the tested treatment separately for racial groups and performed analyses stratified by race.
Race is poorly studied in bladder cancer clinical trials. Trial cohorts may not reflect multicultural populations. The potential association between race and efficacy, safety or tolerability of the tested interventions is unknown. Given the up to twofold increase in bladder cancer-specific death among African-Americans, further research is needed to address the impact of race in clinical trials, while encompassing socioeconomic factors and disease risk factor exposures.
系统地回顾文献，调查膀胱癌临床试验参与者中的种族差异。
使用 Ovid 和 MEDLINE®进行系统综述，以确定 1970 年至 2020 年期间的临床试验。如果临床试验报告了膀胱癌患者的种族结局数据，则对这些文章进行了审查和纳入。该综述符合 PRISMA 声明。
我们确定了 544 项符合初始搜索标准的临床试验，只有 24 项（4.4%）研究报告了种族人口统计学数据。参与者主要是白种人（81-98%），而登记的患者中非洲裔美国人（2-8%）和西班牙裔（2-5%）的比例惊人地小。只有一项研究分别报告了种族群体中测试治疗的疗效和安全性/耐受性的结果，并按种族进行了分层分析。
在膀胱癌临床试验中，种族研究不足。试验队列可能无法反映多元文化人群。种族与测试干预措施的疗效、安全性或耐受性之间的潜在关联尚不清楚。鉴于非洲裔美国人膀胱癌特异性死亡增加了一倍，需要进一步研究种族在临床试验中的影响，同时包括社会经济因素和疾病风险因素暴露。
