Department of Data Science in Mathematics, Herbert W. Boyer School of Natural Sciences, Mathematics, and Computing, Saint Vincent College, Latrobe, Pennsylvania.
Department of Marketing, Analytics and Global Commerce, Saint Vincent College, Latrobe, Pennsylvania.
JAMA Netw Open. 2024 Nov 4;7(11):e2447635. doi: 10.1001/jamanetworkopen.2024.47635.
Disparities in minoritized racial and ethnic populations' participation in gynecologic cancer clinical trials are well documented despite the high rates of endometrial cancer in these populations. Geographic proximity to trials is a critical component to ensure equitable trial access.
To characterize the geographic distribution of gynecological cancer trials across the US and identify disparities.
DESIGN, SETTING, AND PARTICIPANTS: This study is a cross-sectional analysis of trials first posted on ClinicalTrials.gov from January 1, 2013, through January 10, 2024. This study involved a state-level analysis of clinical trials located in the US. Enrollment criteria of clinical trials for ovarian, uterine, cervical, endometrial, vaginal and/or vulvar, and other gynecological cancers were reviewed to exclude nongynecological cancers (1643 trials) or noninvasive gynecological conditions (224 trials).
The number of gynecological trials per 100 000 persons in each state.
A state-level analysis was performed to determine whether gynecologic cancer clinical trial availability in the US is associated with other state-level characteristics to identify areas of increased need. Census data, state-level total population size, percentage of non-Hispanic White persons, and the Federal Emergency Management Agency expected annual loss per state as a measure of social vulnerability were aggregated. The association between these variables and the number of gynecological trials per 100 000 persons was measured using Spearman rank correlation.
Of the 1561 invasive gynecological cancer trials that met the inclusion criteria, most cancer trials were ovarian (911 trials [58.4%]), followed by cervical (438 trials [28.1%]), and endometrial (385 trials [24.7%]). Predominantly minoritized population-serving states (ie, those with <50% non-Hispanic White persons) had fewer than 4 trials per 100 000 persons, but this was not significant nationally (ρ = 0.20; 95% CI, -0.08 to 0.45; P = .16). States with higher Federal Emergency Management Agency expected annual loss had lower numbers of gynecological trials per 100 000 persons, which was significant nationally (ρ = -0.53; 95% CI, -0.70 to -0.29; P < .001).
In this cross-sectional study of female gynecological cancer trials by state, states with particularly high economic vulnerability and minoritized populations had low clinical trial availability. Further efforts are needed to address disparities identified in this study to ensure equitable trial access.
尽管少数族裔人群的子宫内膜癌发病率很高，但这些人群参与妇科癌症临床试验的比例存在差异，这一点已得到充分证明。靠近试验的地理位置是确保公平获得试验机会的关键因素。
描述美国妇科癌症试验的地理分布，并确定差异。
设计、设置和参与者：这是一项对 2013 年 1 月 1 日至 2024 年 1 月 10 日期间首次在 ClinicalTrials.gov 上发布的试验的横断面分析。本研究对美国的临床试验进行了州级分析。对卵巢、子宫、宫颈、子宫内膜、阴道和/或外阴以及其他妇科癌症的临床试验的纳入标准进行了审查，以排除非妇科癌症（1643 项试验）或非侵入性妇科疾病（224 项试验）。
每个州每 100000 人参加的妇科试验数量。
对州一级的分析表明，美国妇科癌症临床试验的可用性与其他州一级特征相关，以确定需要增加的领域。对人口普查数据、州一级总人口规模、非西班牙裔白人比例以及作为社会脆弱性衡量标准的每个州的联邦紧急事务管理局预期年损失进行了汇总。使用 Spearman 秩相关来衡量这些变量与每 100000 人参加的妇科试验数量之间的关系。
在符合纳入标准的 1561 项侵袭性妇科癌症试验中，大多数癌症试验是卵巢癌（911 项[58.4%]），其次是宫颈癌（438 项[28.1%]）和子宫内膜癌（385 项[24.7%]）。以少数族裔为主要服务对象的州（即，非西班牙裔白人比例<50%的州）每 100000 人不到 4 项试验，但这在全国范围内并不显著（ρ=0.20；95%CI，-0.08 至 0.45；P=0.16）。联邦紧急事务管理局预期年损失较高的州每 100000 人参加的妇科试验数量较低，这在全国范围内具有统计学意义（ρ=-0.53；95%CI，-0.70 至-0.29；P<0.001）。
在这项按州对女性妇科癌症试验的横断面研究中，经济脆弱性和少数族裔人群特别高的州的临床试验可用性较低。需要进一步努力解决本研究中确定的差异，以确保公平获得试验机会。
