A population study of clinical trial accrual for women and minorities in neuro-oncology following the NIH Revitalization Act.
A population study of clinical trial accrual for women and minorities in neuro-oncology following the NIH Revitalization Act.
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根据 NIH 振兴法案，对神经肿瘤学领域的女性和少数族裔进行临床试验应计的人群研究。
DOI：
10.1093/neuonc/noac011
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发表时间：
2022
期刊：
影响因子：
15.9
通讯作者：
Hervey-Jumper,ShawnL
中科院分区：
文献类型：
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作者：
Reihl,SheantelJ;Patil,Nirav;Morshed,RaminA;Mehari,Mulki;Aabedi,Alexander;Chukwueke,UgonmaN;Porter,AlyxB;Fontil,Valy;Cioffi,Gino;Waite,Kristin;Kruchko,Carol;Ostrom,Quinn;Barnholtz-Sloan,Jill;Hervey-Jumper,ShawnL
背景NIH振兴法案于29年前实施，旨在提高女性和少数族裔在临床试验中的代表性。在这项研究中，我们调查了神经上皮性中枢神经系统肿瘤的所有阶段治疗临床试验的进展情况，根据人口统计的特定年龄调整的疾病发生率和死亡率进行分层。此外，我们确定了与符合已建立的应计基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月期间发表的世界卫生组织定义的神经上皮性中枢神经系统肿瘤的临床试验进行注册研究。研究参与者来自PubMed和ClinicalTrials.gov。基于人口的数据来源于CBTRUS，用于发病率分析。死亡率分析采用基于SEER-18发病率的死亡率数据。结果在662项已发表的临床试验中，62.5%的研究对象为男性，37.5%的研究对象为女性(P<；.0001)，男性的死亡率高于男性(P=.0001)。白人、亚裔、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)低于白人(预期死亡率的114%，P<；.001)。符合种族应计基准的临床试验包括少数族裔作者。结论在《振兴法案》之后，相对于发病率和死亡率，少数族裔和妇女在神经上皮性肿瘤的治疗临床试验中的代表性仍然不足。学习收益随着时间的推移而提高。这项研究为临床试验的应计努力提供了一个框架，并提供了与服务不足的患者登记相关的劳动力考虑的指导。
BackgroundThe 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.MethodsRegistry 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 χ2tests were used for data analysis.ResultsAmong 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.ConclusionsFollowing 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.