Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland 21231, USA.
Clin Cancer Res. 2010 Dec 15;16(24):5997-6003. doi: 10.1158/1078-0432.CCR-10-1451.
Cancer patients at Johns Hopkins undergo insurance clearance to verify coverage for enrollment to interventional clinical trials. We sought to explore the impact of insurance clearance on disparities in access to cancer clinical trials at this urban comprehensive cancer center.
We evaluated the frequency of insurance-based denial of access to cancer clinical trials over a 5-year period after initiation of a formal insurance clearance process. We used a case-control design to compare demographic and clinical parameters of patients denied or approved for clinical trials participation by their insurance company in a 3-year interval.
From July 2003 to July 2008, insurance requests for clinical trial participation were submitted on 4,617 consented cancer patients at Johns Hopkins. A total of 628 patients (13.6%) with health insurance were denied therapeutic trial enrollment owing to lack of insurance coverage for participation. A total of 254 patients denied enrollment from 2005 to 2007 were selected for further analysis. Two-hundred sixty randomly selected patients approved for clinical trial participation served as controls. Patients approved were on average older (59.2 versus 54.9 years) than patients denied (P = 0.0001). Residents of Pennsylvania, which lacks a state law mandating cancer clinical trial coverage for residents, were overrepresented among the denied patients (P = 0.0009). No statistically significant variance in the likelihood of insurance denial was found on the basis of sex, race, stage of disease, or presence of comorbidities.
Denial of access to therapeutic clinical trials, even among insured patients, is a significant barrier to clinical cancer research. This barrier spans racial, ethnic, and gender categories.
约翰霍普金斯大学的癌症患者需要进行保险资格审查，以核实其是否有资格参加介入性临床试验。我们旨在探讨在这家城市综合性癌症中心，保险资格审查对癌症临床试验参与机会差异的影响。
我们评估了在正式保险资格审查程序启动后的 5 年内，因保险原因而被拒绝参加癌症临床试验的频率。我们采用病例对照设计，比较了保险公司拒绝或批准患者参与临床试验的 3 年间隔期内的患者人口统计学和临床参数。
从 2003 年 7 月至 2008 年 7 月，在约翰霍普金斯大学的 4617 名同意参加癌症临床试验的患者中，有 628 名（13.6%）有医疗保险的患者因保险范围不包括参与试验而被拒绝参加治疗性试验。共有 254 名 2005 年至 2007 年期间被拒绝参加试验的患者被选入进一步分析。随机选择 260 名被批准参加临床试验的患者作为对照组。与被批准的患者相比，被拒绝的患者平均年龄更大（59.2 岁对 54.9 岁，P = 0.0001）。宾夕法尼亚州没有州法律要求为居民提供癌症临床试验覆盖，该州居民在被拒绝的患者中占比较高（P = 0.0009）。在性别、种族、疾病分期或合并症方面，未发现保险拒绝的可能性有统计学上的显著差异。
即使在有保险的患者中，被拒绝参与治疗性临床试验也是临床癌症研究的一个重大障碍。这种障碍跨越了种族、民族和性别类别。
