A Case-Control Study Examining Disparities in Clinical Trial Participation Among Breast Surgical Oncology Patients
A Case-Control Study Examining Disparities in Clinical Trial Participation Among Breast Surgical Oncology Patients
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DOI：
10.1093/jncics/pkz103
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发表时间：
2020-04-01
影响因子：
4.4
通讯作者：
Stewart, John H.
中科院分区：
文献类型：
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作者：
Fayanju, Oluwadamilola M.;Ren, Yi;Stewart, John H.
背景：尽管国家做出了努力，但种族和少数民族中的临床试验参与率仍然很低。我们试图确定乳腺外科肿瘤学患者参与临床试验的情况如何随时间的推移而变化，以及参与试验的特征与参与的关系。方法：将2000-2012年参加国家癌症研究所赞助的合作组试验的乳腺癌患者(n=17125)与2000-2012年在国家癌症数据库中诊断的符合试验条件的女性(n=792719)进行比较。特定种族的试验参与情况是根据收入在一段时间内绘制的，并作为合并队列的比例报告。与试验参与相关的因素使用Logistic回归进行评估；我们报告的优势比(OR)具有95%的可信区间(CI)。在所有分析中，P值小于0.05被认为具有统计学意义。结果：由于试验的规模和数量的减少，所有组的参与率都随着时间的推移而下降。在2000-2003年，来自最高收入群体的亚太岛民(7.17%)、西班牙裔(3.48%)和白人(7.13%)患者的参与率高于低收入群体(亚太岛民：3.95%；西班牙裔：2.67%；白人：5.96%)，但到2008-2012年，只有高收入白人患者的参与率高于低收入白人患者(0.32%对0.25%，均P
Background: Clinical trial participation among racial and ethnic minorities remains low despite national efforts. We sought to determine how participation in clinical trials by breast surgical oncology patients has changed over time and what characteristics are associated with participation.Methods: Women with breast cancer enrolled in National Cancer Institute-sponsored, cooperative-group trials from 2000 to 2012 and who underwent oncologic surgery (n = 17 125) were compared with trial-eligible women in the National Cancer Database diagnosed in 2000-2012 (n = 792 719). Race-specific trial participation was plotted over time by income and reported as a proportion of the combined cohorts. Factors associated with trial participation were estimated using logistic regression; we report odds ratios (ORs) with 95% confidence intervals (CIs). A P value less than .05 was considered statistically significant for all analyses. All tests were two-sided.Results: Participation declined across all groups over time because of a decrease in the scale and number of trials. In 2000-2003, Asian-Pacific Islander (7.17%), Hispanic (3.48%), and white (7.13%) patients from the highest income group had higher participation than their lower-income counterparts (Asian-Pacific Islander: 3.95%; Hispanic: 2.67%; white: 5.96%), but by 2008-2012, only high-income white patients participated more than lower-income whites (0.32% vs 0.25%, all P