Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Perlmutter Cancer Center, New York University Langone Health, New York, NY; Bellevue Hospital, New York, NY.
Obstetrics & Gynecology Institute, Cleveland Clinic, Cleveland, OH.
Am J Obstet Gynecol. 2024 Jan;230(1):73.e1-73.e14. doi: 10.1016/j.ajog.2023.09.019. Epub 2023 Sep 24.
Participation in clinical trials may help mitigate disparate cancer outcomes. Thus, ensuring equitable access to clinical trials is a major priority for national cancer organizations.
This study aimed to examine clinical trial eligibility criteria that may adversely affect the enrollment of underrepresented groups and assess the availability of demographic information in published gynecologic oncology studies.
ClinicalTrials.gov was searched for gynecologic oncology studies conducted between 1997 and 2021. Each study's inclusion and exclusion criteria were reviewed to determine whether demographic factors were used for enrollment screening. For published studies, demographic variables that were reported were identified. The expected clinical trial enrollment based on disease incidence and mortality was compared with the observed trial enrollment based on race.
There were 1597 gynecologic oncology studies: 883 (55%) from ovarian cancer studies, 336 (21%) from cervical cancer studies, 262 (17%) from uterine cancer studies, and 116 (7%) from multisite gynecologic oncology studies. Of the 581 published studies, 554 (95%) reported age, 363 (63%) reported race, and 171 (29%) reported ethnicities. Cervical cancer studies were most likely to report demographic information, including race (P=.026) and ethnicity (P<.001). During the study period, 189 studies (12%) excluded patients based on the language spoken. Industry-sponsored trials (odds ratio, 0.07; 95% confidence interval, 0.02-0.30) and organization-sponsored trials (odds ratio, 0.40; 95% confidence interval, 0.22-0.73) were less likely to exclude patients because of language than investigator-initiated trials. A minority of patients (37%) in cervical cancer trials were of White race, compared with 85% of patients in uterine cancer trials and 82% of patients in ovarian cancer trials.
Over the last 3 decades, 1 in 10 gynecologic oncology trials excluded patients because of language. Race and ethnicity were reported in more than half of the available studies. Initiatives to increase transparency in recruiting underrepresented patients and reporting demographic data are urgently needed.
参与临床试验可能有助于减轻癌症结果的差异。因此，确保公平获得临床试验是国家癌症组织的主要优先事项。
本研究旨在检查可能对代表性不足的群体入组产生不利影响的临床试验纳入标准，并评估已发表妇科肿瘤学研究中人口统计学信息的可用性。
在 1997 年至 2021 年期间，对 ClinicalTrials.gov 进行了搜索，以寻找妇科肿瘤学研究。审查了每项研究的纳入和排除标准，以确定是否使用人口统计学因素进行入组筛选。对于已发表的研究，确定了报告的人口统计学变量。根据疾病发病率和死亡率预期的临床试验入组人数与基于种族的观察性试验入组人数进行了比较。
共有 1597 项妇科肿瘤学研究：883 项（55%）来自卵巢癌研究，336 项（21%）来自宫颈癌研究，262 项（17%）来自子宫癌研究，116 项（7%）来自多部位妇科肿瘤学研究。在 581 项已发表的研究中，554 项（95%）报告了年龄，363 项（63%）报告了种族，171 项（29%）报告了民族。宫颈癌研究最有可能报告人口统计学信息，包括种族（P=.026）和民族（P<.001）。在研究期间，有 189 项（12%）研究因语言原因排除了患者。与研究者发起的试验相比，工业赞助试验（比值比，0.07；95%置信区间，0.02-0.30）和组织赞助试验（比值比，0.40；95%置信区间，0.22-0.73）排除因语言原因的患者的可能性较小。在宫颈癌试验中，只有 37%的患者为白种人，而在子宫癌试验中，这一比例为 85%，在卵巢癌试验中，这一比例为 82%。
在过去的 30 年中，每 10 项妇科肿瘤学试验中就有 1 项因语言原因排除了患者。超过一半的可用研究报告了种族和民族。迫切需要采取措施提高对代表性不足的患者的招募透明度，并报告人口统计学数据。
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