Representativeness of Black Patients in Cancer Clinical Trials Sponsored by the National Cancer Institute Compared With Pharmaceutical Companies
Representativeness of Black Patients in Cancer Clinical Trials Sponsored by the National Cancer Institute Compared With Pharmaceutical Companies
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DOI：
10.1093/jncics/pkaa034
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发表时间：
2020-08-01
影响因子：
4.4
通讯作者：
Raghav, Kanwal
中科院分区：
文献类型：
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作者：
Unger, Joseph M.;Hershman, Dawn L.;Raghav, Kanwal
背景：许多支持新药申请的临床试验代表性不足。国家癌症研究所的国家临床试验网络（NCTN）进行的试验与社区网站有更大的联系，可能会有更好的代表性。我们比较了黑人患者在制药公司赞助的癌症临床试验与NCTN试验和美国癌症人群中的代表性。研究方法：我们建立了一个大型研究出版物队列，代表了2008年至2018年支持美国食品药品监督管理局新药批准的试验结果。NCTN试验数据来自SWOG癌症研究网络。使用监测、流行病学和最终结果调查数据估计美国癌症人群发病率。我们比较了每种癌症类型和总体的黑人患者比例。使用了比例测试。所有统计检验均为双侧检验。结果如下：共分析了15种癌症类型的358项试验（制药公司申办的试验，85项; SWOG试验，273项），包括93 825例患者（制药公司申办的试验，46 313项; SWOG试验，47 512项）。总体而言，在制药公司赞助的试验中，黑人患者的比例为2.9%，在SWOG试验中为9.0%，在美国癌症人群中为12.1%（P
Background: Many clinical trials supporting new drug applications underrepresent minority patients. Trials conducted by the National Cancer Institute's National Clinical Trial's Network (NCTN) have greater outreach to community sites, potentially allowing better representation. We compared the representation of Black patients in pharmaceutical company-sponsored cancer clinical trials with NCTN trials and with the US cancer population. Methods: We established a large cohort of study publications representing the results of trials that supported new US Food and Drug Administration drug approvals from 2008 to 2018. NCTN trial data were from the SWOG Cancer Research Network. US cancer population rates were estimated using Surveillance, Epidemiology, and End Results survey data. We compared the proportion of Black patients by enrollment year for each cancer type and overall. Tests of proportions were used. All statistical tests were 2-sided. Results: A total 358 trials (pharmaceutical company-sponsored trials, 85; SWOG trials, 273) comprised of 93 825 patients (pharmaceutical company-sponsored trials, 46 313; SWOG trials, 47 512) for 15 cancer types were analyzed. Overall, the proportion of Black patients was 2.9% for pharmaceutical company-sponsored trials, 9.0% for SWOG trials, and 12.1% for the US cancer population (P