一项针对神经肿瘤学中女性和少数族裔临床试验入组的人口研究，该研究是在 NIH 复兴法案之后进行的。
A population study of clinical trial accrual for women and minorities in neuro-oncology following the NIH Revitalization Act.
机构信息
University of California, San Francisco, Department of Neurosurgery, San Francisco, California,USA.
Central Brain Tumor Registry of the United States (CBTRUS), Hinsdale, Illinois, USA.
出版信息
Neuro Oncol. 2022 Aug 1;24(8):1341-1349. doi: 10.1093/neuonc/noac011.
BACKGROUND
The NIH Revitalization Act, implemented 29 years ago, set to improve the representation of women and minorities in clinical trials. In this study, we investigate progress made in all phase therapeutic clinical trials for neuroepithelial CNS tumors stratified by demographic-specific age-adjusted disease incidence and mortality. Additionally, we identify workforce characteristics associated with clinical trials meeting established accrual benchmarks.
METHODS
Registry study of published clinical trials for World Health Organization defined neuroepithelial CNS tumors between January 2000 and December 2019. Study participants were obtained from PubMed and ClinicalTrials.gov. Population-based data originated from the CBTRUS for incidence analyses. SEER-18 Incidence-Based Mortality data was used for mortality analysis. Descriptive statistics, Fisher exact, and χ 2 tests were used for data analysis.
RESULTS
Among 662 published clinical trials representing 49 907 participants, 62.5% of participants were men and 37.5% women (P < .0001) representing a mortality specific over-accrual for men (P = .001). Whites, Asians, Blacks, and Hispanics represented 91.7%, 1.5%, 2.6%, and 1.7% of trial participants. Compared with mortality, Blacks (47% of expected mortality, P = .008), Hispanics (17% of expected mortality, P < .001) and Asians (33% of expected mortality, P < .001) were underrepresented compared with Whites (114% of expected mortality, P < .001). Clinical trials meeting accrual benchmarks for race included minority authorship.
CONCLUSIONS
Following the Revitalization Act, minorities and women remain underrepresented in therapeutic clinical trials for neuroepithelial tumors, relative to disease incidence and mortality. Study accrual has improved with time. This study provides a framework for clinical trial accrual efforts and offers guidance regarding workforce considerations associated with enrollment of underserved patients.
背景
29 年前实施的 NIH 复兴法案旨在提高临床试验中女性和少数族裔的代表性。在这项研究中，我们调查了按特定年龄调整的疾病发病率和死亡率分层的所有治疗阶段治疗性临床试验中神经上皮性 CNS 肿瘤的进展。此外，我们确定了与符合既定入组标准的临床试验相关的劳动力特征。
方法
对 2000 年 1 月至 2019 年 12 月间发表的世界卫生组织定义的神经上皮性 CNS 肿瘤的临床试验进行注册研究。研究参与者来自 PubMed 和 ClinicalTrials.gov。发病率分析的人群数据来自 CBTRUS。使用 SEER-18 基于发病率的死亡率数据进行死亡率分析。使用描述性统计、Fisher 精确检验和 χ²检验进行数据分析。
结果
在 662 项发表的临床试验中，共有 49907 名参与者，其中 62.5%为男性，37.5%为女性（P<.0001），这表明男性的死亡率特定入组人数过多（P=.001）。白人、亚洲人、黑人和西班牙裔分别占试验参与者的 91.7%、1.5%、2.6%和 1.7%。与死亡率相比，黑人（预期死亡率的 47%，P=.008）、西班牙裔（预期死亡率的 17%，P<.001）和亚洲人（预期死亡率的 33%，P<.001）的入组人数低于白人（预期死亡率的 114%，P<.001）。符合种族入组标准的临床试验包括少数族裔作者。
结论
自复兴法案实施以来，与疾病发病率和死亡率相比，神经上皮性肿瘤的治疗性临床试验中少数族裔和女性的代表性仍然不足。随着时间的推移，研究入组情况有所改善。本研究为临床试验入组工作提供了框架，并为纳入服务不足的患者相关的劳动力考虑因素提供了指导。
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