Minority participation in Gynecologic Oncology Group (GOG) Studies
Minority participation in Gynecologic Oncology Group (GOG) Studies
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DOI：
10.1016/j.ygyno.2015.05.014
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发表时间：
2015-08-01
影响因子：
4.7
通讯作者：
Rocconi, Rodney P.
中科院分区：
文献类型：
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作者：
Scalici, Jennifer;Finan, Michael A.;Rocconi, Rodney P.
目标。少数群体参与临床试验对于了解和克服癌症种族差异至关重要。该项目的目标是评估少数人参与已发表的GOG临床试验。审查了1985年至2013年期间的政府间出版物。少数民族入选按肿瘤部位、研究类型和发表年份进行分层。根据美国疾病控制和预防中心(CDC)的种族年龄调整发病率，计算种族参与的预期比率和观察比率。总共回顾了涉及67,568名患者的445篇GOG出版物。170项研究(38%)提供了总计45259名患者的种族分类：83%的白人(n=37617)、8%的黑人(n=3686)和9%的其他(n=3956)。大多数研究是卵巢研究(n=202)和2期研究(n=290)。在评估发表年的四分位数时，黑人患者的登记比例稳步下降。在1994年之前，没有任何出版物报道种族问题。与1994-2002年相比，2009-2013年黑人入学比例下降了2.8倍(分别为16%和5.8%；p<；0.01)。利用疾病预防控制中心年龄调整后的发病率，观察到参加GOG临床试验的黑人患者明显少于预期登记人数，观察到黑人参加卵巢试验的人数比预期的低15倍，子宫内膜试验的黑人登记人数减少10倍，宫颈试验的黑人患者登记人数减少4.5%，肉瘤患者的登记人数减少5.2%(每个P<；0.001)。根据年龄调整的发病率，观察到的黑人患者参加COG研究的人数低于预期。尽管国家强调临床试验中少数族裔的登记，但随着时间的推移，纳入的黑人患者越来越少。(C)2015 Elsevier Inc.保留所有权利。
Objective. Participation of minority populations in clinical trials is paramount to understanding and overcoming cancer racial disparities. The goal of this project is to evaluate minority participation in published GOG clinical trials.Methods. GOG publications from 1985 to 2013 were reviewed. Minority enrollment was stratified by tumor site, type of study, and year published. Based on Centers of Disease Control and Prevention (CDC) age-adjusted incidence for race, expected and observed ratios of racial participation were calculated.Results. A total of 445 GOG publications involving 67,568 patients were reviewed. Racial breakdown was provided in 170 studies (38%) for a total of 45,259 patients: 83% White (n = 37,617); 8% Black (n = 3,686), and 9% Other (n = 3,956). The majority of studies were Ovarian (n = 202) and Phase 2 (n = 290). When evaluating the quartiles of publication year, a steady decline in the proportion of Black patients enrolled was seen. Race was not reported in any publication prior to 1994. Compared to years 1994-2002, a 2.8-fold lower proportion of black enrollment was noted in years 2009-2013 (16% and 5.8%, respectively; p < 0.01). Utilizing CDC age-adjusted incidence, observed enrollment of Black patients onto GOG clinical trials was significantly less than expected enrollment Observed Black enrollment was 15-fold lower than expected for ovarian trials, 10-fold lower for endometrial, 4.5-fold for cervix, and 5.2-fold for sarcoma (each p < 0.001).Conclusions. Based on age-adjusted incidence, observed enrollment of Black patients was lower than expected enrollment onto COG studies. Despite national emphasis on minority enrollment on clinical trials, fewer Black patients were enrolled over time. (C) 2015 Elsevier Inc. All rights reserved.