Department of Pharmacy Practice and Clinical Health Sciences, College of Pharmacy and Health Sciences, Texas Southern University, Houston, TX.
Department of Pharmacy, Houston Methodist Hospital, Houston, TX.
JCO Oncol Pract. 2021 May;17(5):e623-e628. doi: 10.1200/OP.20.01108.
Over the past 10 years, oral chemotherapy made up about half (45.6%) of all US Food and Drug Administration (FDA)-approved oncolytic and hematologic medications. Given the disparity in incidence and mortality rate because of certain cancers among Black Americans (BAs) in the United States, a review of BA's representation in the clinical trials that lead to the development and FDA approval of oral chemotherapy drugs becomes imperative. The objective of this study was to evaluate the reporting of race and inclusion of BA in clinical trials that led to the approval of oral chemotherapy medications by the FDA from 2009 to 2019 in the United States. Additionally, we evaluated the inclusion of BAs in clinical trials of three cancer types with the highest disparity rates among BAs (lung, breast, and prostate).
A retrospective review of all FDA-approved oral chemotherapy drug from 2009-2019 was obtained using the FDA's Hematology/Oncology Approvals & Safety Notifications website. Reports of racial and demographics inclusion were obtained from the clinical trials registry.
Primary outcome: 142 clinical trials led to FDA approval of 81 oral chemotherapy agents between 2009 and 2019, among which 74 (52%) reported on at least one race and were included in our analysis. 35,933 participants were enrolled in these 74 clinical trials, among which 25,684 (71.47%), 6,061 (16.87%), 889 (2.47%), and 826 (2.30%) were White, Asian, Black, and Hispanic, respectively. BAs were also under-represented in the clinical trials of three cancer types with the highest disparity rates among this population.
BAs were under-represented in clinical trials leading to FDA approval of oral chemotherapy drugs. There should be more BAs in cancer clinical trials to increase the generalizability of the results, improve outcomes, and eventually close the health disparity gap among this patient population.
在过去的 10 年中，口服化疗药物约占美国食品和药物管理局（FDA）批准的肿瘤学和血液学药物的一半（45.6%）。鉴于美国黑人（BAs）中某些癌症的发病率和死亡率存在差异，因此有必要审查导致口服化疗药物开发和 FDA 批准的临床试验中 BA 的代表性。本研究的目的是评估从 2009 年到 2019 年，美国 FDA 批准的口服化疗药物临床试验中报告的种族情况以及 BA 的纳入情况。此外，我们还评估了 BA 纳入三种癌症类型临床试验的情况，这三种癌症类型的 BA 差异率最高（肺癌、乳腺癌和前列腺癌）。
使用 FDA 的血液学/肿瘤学批准和安全通知网站，回顾性检索 2009-2019 年所有获得 FDA 批准的口服化疗药物。从临床试验注册处获得种族和人口统计学纳入情况的报告。
主要结果：在 2009 年至 2019 年期间，有 142 项临床试验导致 81 种口服化疗药物获得 FDA 批准，其中 74 种（52%）报告了至少一种种族，并纳入了我们的分析。这 74 项临床试验共纳入 35933 名参与者，其中白人、亚洲人、黑人和西班牙裔分别为 25684 名（71.47%）、6061 名（16.87%）、889 名（2.47%）和 826 名（2.30%）。BA 在这一人群中发病率和死亡率最高的三种癌症类型的临床试验中也代表性不足。
BA 在导致 FDA 批准口服化疗药物的临床试验中代表性不足。应该有更多的 BA 参与癌症临床试验，以提高结果的普遍性，改善结果，并最终缩小这一患者群体的健康差距。
