Loree Jonathan M, Anand Seerat, Dasari Arvind, Unger Joseph M, Gothwal Anirudh, Ellis Lee M, Varadhachary Gauri, Kopetz Scott, Overman Michael J, Raghav Kanwal
BC Cancer, Vancouver, British Columbia, Canada.
Department of Gastrointestinal Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston.
JAMA Oncol. 2019 Oct 1;5(10):e191870. doi: 10.1001/jamaoncol.2019.1870. Epub 2019 Oct 10.
Representative racial/ethnic participation in research, especially in clinical trials that establish standards of care, is necessary to minimize disparities in outcomes and to uphold societal equity in health care.
To evaluate the frequency of race reporting and proportional race representation in trials supporting US Food and Drug Administration (FDA) oncology drug approvals.
DESIGN, SETTING, AND PARTICIPANTS: Database study of all reported trials supporting FDA oncology drug approvals granted between July 2008 and June 2018. Primary reports of trials were obtained from PubMed and ClinicalTrials.gov. Food and Drug Administration approvals were identified using the FDA archives. The US population-based cancer estimates by race were calculated using National Cancer Institute-Surveillance, Epidemiology, and End Results and US Census databases.
Primary outcomes were the proportion of trials reporting race and the proportion of patients by race participating in trials. Secondary outcomes included race subgroup analyses reporting and gaps between race proportion in trials and the US population. Descriptive statistics, Fisher exact, and χ2 tests were used to analyze the data. Proportions and odds ratios (OR) with 95% CIs were reported.
Among 230 trials with a total of 112 293 participants, 145 (63.0%) reported on at least 1 race, 18 (7.8%) documented the 4 major races in the United States (white, Asian, black, and Hispanic), and 58 (25.2%) reported race subgroup analyses. Reporting on white, Asian, black, and Hispanic races was included in 144 (62.6%), 110 (47.8%), 88 (38.2%), and 23 (10.0%) trials, respectively. Between July 2008 and June 2013 vs July 2013 and June 2018, the number of trials reporting race (45 [56.6%] vs 100 [67.1%]; OR, 1.63; 95% CI, 0.93-2.87; P = .09) and race subgroup analysis (13 [16.1%] vs 45 [30.2%]; OR, 2.26, 95% CI, 1.16-4.67; P = .03) changed minimally and varied across races. Whites, Asians, blacks, and Hispanics represented 76.3%, 18.3%, 3.1% and 6.1% of trial participants, respectively, and the proportion for each race enrolled over time changed nominally (blacks, 3.6% vs 2.9% and Hispanics, 5.3% vs 6.7%) from July 2008 to June 2013 vs July 2013 to June 2018. Compared with their proportion of US cancer incidence, blacks (22% of expected) and Hispanics (44% of expected) were underrepresented compared with whites (98% of expected) and Asians (438% of expected).
Race and race subgroup analysis reporting occurs infrequently, and black and Hispanic races are consistently underrepresented compared with their burden of cancer incidence in landmark trials that led to FDA oncology drug approvals. Enhanced minority engagement is needed in trials to ensure the validity of results and reliable benefits to all.
不同种族/族裔群体参与研究，尤其是参与确立医疗护理标准的临床试验，对于尽量减少结果差异以及维护医疗保健领域的社会公平至关重要。
评估在支持美国食品药品监督管理局（FDA）肿瘤药物批准的试验中种族报告的频率以及各种族的代表性比例。
设计、背景和参与者：对2008年7月至2018年6月期间支持FDA肿瘤药物批准的所有已报告试验进行数据库研究。试验的主要报告从PubMed和ClinicalTrials.gov获取。利用FDA档案确定FDA批准情况。使用美国国立癌症研究所监测、流行病学和最终结果数据库以及美国人口普查数据库计算按种族划分的美国人群癌症估计数。
主要结局为报告种族的试验比例以及按种族划分参与试验的患者比例。次要结局包括种族亚组分析报告以及试验中的种族比例与美国人口之间的差距。使用描述性统计、Fisher精确检验和χ2检验分析数据。报告比例和比值比（OR）及其95%置信区间。
在共有112293名参与者的230项试验中，145项（63.0%）报告了至少1个种族，18项（7.8%）记录了美国的4个主要种族（白人、亚洲人、黑人、西班牙裔），58项（25.2%）报告了种族亚组分析。分别有144项（62.6%）、110项（47.8%）、88项（38.2%）和23项（10.0%）试验报告了白人、亚洲人、黑人和西班牙裔种族。2008年7月至20
