美国青光眼临床试验的种族和地域代表性（2004-2023）。

IF 3.2 Q1 OPHTHALMOLOGY

Ophthalmology. Glaucoma Pub Date : 2026-03-01 Epub Date: 2025-10-08 DOI:10.1016/j.ogla.2025.09.011

Jainam Shah BS , Sachin Pathuri BS , Jason Zheng BS , Behram Khan BS , Kemi Okome MD , Jeffrey S. Schultz MD , Anurag Shrivastava MD

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引用次数: 0

摘要

伦理声明：阿尔伯特·爱因斯坦医学院机构审查委员会认为这项研究不需要正式审查，因为它只使用了来自ClinicalTrials.gov的公开数据。由于没有收集或分析患者水平的数据，因此放弃了知情同意的要求，并且不适用。所有分析均按照《赫尔辛基宣言》和STROBE准则进行。目的：青光眼不成比例地影响种族和少数民族人口以及医疗服务不足地区的个人。然而，临床试验数据可能不能反映这种流行病学负担。我们的目的是描述20年来美国青光眼临床试验中种族/民族和地理报告的趋势，并评估与国家人口统计学和疾病患病率相关的参与者代表性差异。设计：回顾性横断面研究。受试者：2004年至2023年间参加美国青光眼II-IV期临床试验的患者。方法：使用所有与青光眼相关的关键词从ClinicalTrials.gov上筛选试验，并根据美国地点、完成状态和≥50名入组受试者进行筛选。试验按入组期进行分层：第1年（2004-2013）和第2年（2014-2023）。人口分布与2010年和2020年美国人口普查数据进行了比较。根据CDC视力和眼健康监测系统（VEHSS）的区域青光眼患病率评估地理代表性。描述性统计、比值比（ORs）和多项卡方检验用于评估报告和代表性的趋势。主要结果测量：种族/民族和地理报告随时间的变化；与全国人口普查和青光眼患病率数据相比，参与者的种族/民族和试验地点分布。结果：在95项试验中，报告种族/族裔的比例从第1年的27.1%增加到第2年的72.3% （OR: 0.14; 95% CI: 0.06-0.35; p < 0.001）。地理报告保持不变（58.3% vs. 51.1%; OR: 1.34; 95% CI: 0.60-3.02; p = 0.539）。在47项报告种族/民族的试验中，13,744名参与者中，黑人患者在这两个十年中都被过度代表（p < 0.001）。西班牙裔和亚裔参与者持续被低估（p < 0.001）。在涉及14997名受试者的52项试验中，东北地区被过度代表（36.2%的试验对18.1%的疾病负担，p = 0.002），而中西部地区的入组率较低（6.4%对20.4%,p = 0.03），尽管经Bonferroni校正后这没有统计学意义。南方和西部按比例代表。结论：尽管种族/民族报告有所改善，但基于美国的青光眼试验仍然不能充分代表西班牙裔、亚裔和中西部人群。这些差异可能会限制试验结果的普遍性，并限制高风险人群获得新兴疗法的机会。

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Ethnoracial and Geographic Representation in United States Glaucoma Clinical Trials (2004–2023)

Purpose

Glaucoma disproportionately affects racial and ethnic minority populations and individuals in medically underserved regions. However, clinical trial data may not reflect this epidemiologic burden. We aimed to characterize trends in race/ethnicity and geographic reporting in US-based glaucoma clinical trials over 2 decades and evaluate disparities in participant representation relative to national demographics and disease prevalence.

Design

A retrospective cross-sectional study.

Subjects

Patients enrolled in US-based phase II–IV clinical trials for glaucoma conducted between 2004 and 2023.

Methods

Trials were identified from ClinicalTrials.gov using all glaucoma-related keywords and filtered for US location, completion status, and ≥50 enrolled participants. Trials were stratified by enrollment period: decade 1 (2004–2013) and decade 2 (2014–2023). Demographic distributions were compared with 2010 and 2020 US census data. Geographic representation was evaluated against regional glaucoma prevalence estimates from the Centers for Disease Control and Prevention Vision and Eye Health Surveillance System. Descriptive statistics, odds ratios (ORs), and multinomial chi-square tests were used to assess trends in reporting and representation.

Main Outcome Measures

Change in reporting of race/ethnicity and geography over time; participant race/ethnicity and trial location distribution compared with national census and glaucoma prevalence data.

Results

Among 95 trials, the proportion reporting race/ethnicity increased from 27.08% in decade 1 to 72.34% in decade 2 (OR: 0.14; 95% confidence interval [CI]: 0.06–0.35; P < 0.001). Geographic reporting remained unchanged (58.33% vs. 51.06%; OR: 1.34; 95% CI: 0.60–3.02; P = 0.539). Across 13 744 participants in 47 trials reporting race/ethnicity, Black patients were overrepresented in both decades (P < 0.001). Hispanic and Asian participants were persistently underrepresented (P < 0.001). In 52 trials with 14 997 participants, the Northeast was overrepresented (36.2% of trials vs. 18.1% of disease burden; P = 0.002), whereas the Midwest had lower enrollment (6.4% vs. 20.4%; P = 0.027), although this was not statistically significant after Bonferroni correction. The South and West were proportionally represented.

Conclusions

Although racial/ethnic reporting has improved, US-based glaucoma trials continue to underrepresent Hispanic, Asian, and, potentially, Midwestern populations. These disparities may limit the generalizability of trial findings and access to emerging therapies for high-risk groups.