调查转移性结直肠癌 (CRC) 临床试验中是否存在种族和民族代表性不足的情况。弱势亚群的代表性对于临床试验的普遍性至关重要。迄今为止，调查参加转移性 CRC 临床试验的患者种族和民族代表性的研究有限。ClinicalTrials.gov 查询了 2000 年至 2020 年美国转移性 CRC 临床试验的情况。发生率数据是从 SEER 数据库中提取的。入组分数 (EF) 定义为试验参与者人数除以美国各种族、民族和性别的转移性 CRC 发病率。代表性商数 (RQ) 定义为每个亚组的试验参与者比例除以美国转移性 CRC 发病率比例。对来自 135 项临床试验的 8084 名患者进行了分析。 49.6% 的临床试验报告了种族数据，34.8% 报告了种族数据。与 2000-2009 年相比，2010-2019 年种族（61.2% vs. 38.8%）和族裔（64.6% vs. 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%，亚裔/太平洋岛民 (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较高（RQ 0.40 vs. 0.86，P=0.034）。需要采取策略来增加转移性结直肠癌临床试验中少数族裔的入组人数。识别系统性障碍是增加代表性的公共政策倡导中不可或缺的一部分。版权所有 © 2024 Wolters Kluwer Health, Inc. 保留所有权利。

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.Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.