Pu Tracey, Gustafson Alexandra, Luberice Kenneth, Akmal Sarfraz R, Li Wei, Hernandez Jonathan M, Blakely Andrew M, Snyder Rebecca A, Eng Oliver S
Surgical Oncology Program, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA 20892.
Division of Computational Biomedicine and the Department of Biological Chemistry, University of California, Irvine, Orange, California, USA 92868.
Ann Surg. 2024 Aug 15. doi: 10.1097/SLA.0000000000006500.
To investigate if underrepresentation of racial and ethnic minorities exists in metastatic colorectal carcinoma (CRC) clinical trials.
Representation of vulnerable subpopulations is essential for generalizability of clinical trials. Limited studies to date have investigated racial and ethnic representation of patients enrolled in clinical trials for metastatic CRC.
ClinicalTrials.gov was queried for metastatic CRC clinical trials in the United States from 2000-2020. Incidence data were extracted from the SEER Database. Enrollment fraction (EF) was defined as number of trial participants divided by U.S. incidence of metastatic CRC in each race, ethnicity, and gender. Representation Quotient (RQ) was defined as the proportion of trial participants divided by proportion of U.S. metastatic CRC incidence for each subgroup.
8084 patients from 135 clinical trials were analyzed. 49.6% of clinical trials reported race data and 34.8% reported ethnicity data. Compared to 2000-2009, 2010-2019 had increased representation data reporting for race (61.2% vs. 38.8%) and ethnicity (64.6% vs. 35.4%). Of trials with race data, White patients represented 77.0%, Black patients 6.6%, Asian/Pacific Islander (API) patients 16.1%, American Indian/Alaska Native (AIAN) patients 0.2%, and Hispanic patients 6.8%. Black patients (median RQ 0.54), API patients (median RQ 0.19), AIAN patients (median RQ 0.00), and Hispanic patients (median RQ 0.26) were underrepresented. Black patients had a higher degree of underrepresentation in clinical trials with serum creatinine inclusion criteria (RQ 0.40 vs. 0.86, P=0.034).
Strategies are needed to increase minority enrollment in clinical trials for metastatic CRC. Identification of systemic barriers is integral in public policy advocacy to increase representation.
调查转移性结直肠癌（CRC）临床试验中是否存在种族和少数民族代表性不足的情况。
弱势群体的代表性对于临床试验的普遍性至关重要。迄今为止，针对转移性CRC临床试验中患者的种族和民族代表性进行研究的较少。
查询ClinicalTrials.gov上2000年至2020年美国的转移性CRC临床试验。发病率数据从监测、流行病学和最终结果（SEER）数据库中提取。入组比例（EF）定义为试验参与者人数除以各种族、民族和性别的美国转移性CRC发病率。代表性商数（RQ）定义为试验参与者比例除以每个亚组的美国转移性CRC发病率比例。
分析了135项临床试验中的8084名患者。49.6%的临床试验报告了种族数据，34.8%报告了民族数据。与2000 - 2009年相比，2010 - 2019年种族（61.2%对38.8%）和民族（64.6%对35.4%）的代表性数据报告有所增加。在有种族数据的试验中，白人患者占77.0%，黑人患者占6.6%，亚太岛民（API）患者占16.1%，美洲印第安人/阿拉斯加原住民（AIAN）患者占0.2%，西班牙裔患者占6.8%。黑人患者（中位RQ 0.54）、API患者（中位RQ 0.19）、AIAN患者（中位RQ 0.00）和西班牙裔患者（中位RQ 0.26）代表性不足。在有血清肌酐纳入标准的临床试验中，黑人患者的代表性不足程度更高（RQ 0.40对0.86，P = 0.034）。
需要采取策略增加转移性CRC临床试验中的少数群体入组。识别系统性障碍是公共政策倡导增加代表性的重要组成部分。
