Underrepresentation of Racial and Ethnic Minorities in Metastatic Colorectal Carcinoma Clinical Trials Within the United States.

IF 6.4 1区医学 Q1 SURGERY Annals of surgery Pub Date : 2026-02-01 Epub Date: 2024-08-15 DOI:10.1097/SLA.0000000000006500

Tracey Pu, Alexandra Gustafson, Kenneth Luberice, Sarfraz R Akmal, Wei Li, Jonathan M Hernandez, Andrew M Blakely, Rebecca A Snyder, Oliver S Eng

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Abstract

Objective: To investigate whether underrepresentation of racial and ethnic minorities exists in metastatic colorectal carcinoma (CRC) clinical trials.

Background: Representation of vulnerable subpopulations is essential for the generalizability of clinical trials. Limited studies to date have investigated the racial and ethnic representation of patients enrolled in clinical trials for metastatic CRC.

Methods: ClinicalTrials.gov was queried for metastatic CRC clinical trials in the United States from 2000 to 2020. Incidence data were extracted from the SEER Database. Enrollment fraction was defined as the number of trial participants divided by U.S. incidence of metastatic CRC in each race, ethnicity, and sex. Representation quotient (RQ) was defined as the proportion of trial participants divided by the proportion of U.S. metastatic CRC incidence for each subgroup.

Results: A total of 8084 patients from 135 clinical trials were analyzed. Of clinical trials, 49.6% reported race data and 34.8% reported ethnicity data. Compared with 2000 to 2009, 2010 to 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 patients 16.1%, American Indian/Alaska Native patients 0.2%, and Hispanic patients 6.8%. Black patients (median RQ: 0.54), Asian/Pacific Islander patients (median RQ: 0.19), American Indian/Alaska Native 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).

Conclusions: 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.

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美国转移性结直肠癌临床试验中少数种族和族裔的代表性不足。

目的调查在转移性结直肠癌（CRC）临床试验中是否存在少数种族和少数族裔代表性不足的情况：弱势亚群的代表性对于临床试验的推广至关重要。迄今为止，对参加转移性结直肠癌临床试验患者的种族和民族代表性进行调查的研究十分有限：方法：通过 ClinicalTrials.gov 查询了 2000-2020 年间美国的转移性 CRC 临床试验。发病率数据来自 SEER 数据库。入组比例（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。代表商数（RQ）的定义是试验参与者的比例除以每个亚组的美国转移性 CRC 发病率的比例：对 135 项临床试验中的 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%报告了族裔数据。与 2000-2009 年相比，2010-2019 年报告种族（61.2% 对 38.8%）和种族（64.6% 对 35.4%）数据的代表性有所增加。在有种族数据的试验中，白人患者占 77.0%，黑人患者占 6.6%，亚太裔患者占 16.1%，美洲印第安人/阿拉斯加原住民患者占 0.2%，西班牙裔患者占 6.8%。黑人患者（中位数 RQ 0.54）、亚太裔患者（中位数 RQ 0.19）、美洲印第安人患者（中位数 RQ 0.00）和西班牙裔患者（中位数 RQ 0.26）的代表性不足。在有血清肌酐纳入标准的临床试验中，黑人患者的代表性较低（RQ 0.40 vs. 0.86，P=0.034）：结论：需要制定策略，提高少数族裔参与转移性 CRC 临床试验的人数。结论：需要制定策略，提高少数族裔在转移性 CRC 临床试验中的参与率。确定系统性障碍是公共政策宣传中不可或缺的一部分，以提高代表性。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Annals of surgery 医学-外科

CiteScore

14.40

自引率

4.40%

发文量

687

审稿时长

4 months

期刊介绍： The Annals of Surgery is a renowned surgery journal, recognized globally for its extensive scholarly references. It serves as a valuable resource for the international medical community by disseminating knowledge regarding important developments in surgical science and practice. Surgeons regularly turn to the Annals of Surgery to stay updated on innovative practices and techniques. The journal also offers special editorial features such as "Advances in Surgical Technique," offering timely coverage of ongoing clinical issues. Additionally, the journal publishes monthly review articles that address the latest concerns in surgical practice.