Division of Hematology and Oncology, University of Illinois Chicago, Chicago, IL.
Division of General Internal Medicine, Massachusetts General Hospital, Boston, MA.
Clin Breast Cancer. 2023 Aug;23(6):591-597. doi: 10.1016/j.clbc.2023.05.001. Epub 2023 May 10.
We determined the race and ethnicity demographics and reporting trends of clinical trials leading to Food and Drug Administration (FDA) approvals for breast cancer.
We collected enrollment and reporting data from clinical trials leading to FDA novel and new use approvals for breast cancer from 2010 to 2020 from Drugs@FDA, ClinicalTrials.gov, and associated journal manuscripts. Enrollment demographics were compared to the US cancer population estimates obtained using National Cancer Institute-Surveillance, Epidemiology, and End Results and 2010 US Census databases.
Seventeen drugs received approval based on 18 clinical trials with a total enrollment of 12,334. For approvals from 2010 to 2015 and from 2016 to 2020, there was no significant difference in race (80% vs. 91.6%, P = .34) or ethnicity reporting (20% vs. 33.3%, P = .5) on ClinicalTrials.Gov, manuscripts, and FDA labels. For trials that reported race and ethnicity, White, Asian, Black, and Hispanic patients represented 73.8%, 16.4%, 3.7%, and 10.4% of trial participants. Relative to their US cancer incidence, Black (31% of expected) patients were underrepresented compared with White (90% of expected), Hispanic (115%), and Asian (327% of expected) patients.
We observed no significant difference in race and ethnicity reporting in pivotal clinical trials leading to FDA approval for breast cancer from 2010 to 2020. Black patients were underrepresented in these pivotal trials relative to White, Hispanic, and Asian patients. Ethnicity reporting remained low throughout the study period. Innovative approaches are needed to ensure equitable benefit of novel therapeutics.
我们确定了导致食品和药物管理局 (FDA) 批准乳腺癌的临床试验的种族和族裔人口统计数据和报告趋势。
我们从 2010 年至 2020 年从 Drugs@FDA、ClinicalTrials.gov 以及相关的期刊手稿中收集了导致 FDA 新型和新用途批准的乳腺癌临床试验的入组和报告数据。将入组人口统计学数据与使用国家癌症研究所监测、流行病学和最终结果数据库和 2010 年美国人口普查数据库获得的美国癌症人群估计值进行比较。
基于 18 项临床试验，有 17 种药物获得批准，总入组人数为 12334 人。对于 2010 年至 2015 年和 2016 年至 2020 年的批准，ClinicalTrials.gov、手稿和 FDA 标签上的种族（80%对 91.6%，P=0.34）或族裔报告（20%对 33.3%，P=0.5）没有显著差异。对于报告种族和族裔的试验，白人、亚洲人、黑人和西班牙裔患者分别占试验参与者的 73.8%、16.4%、3.7%和 10.4%。与他们在美国癌症发病率相比，黑人（预期的 31%）患者的代表性不足，而白人（预期的 90%）、西班牙裔（115%）和亚洲人（预期的 327%）患者的代表性过高。
我们观察到，在 2010 年至 2020 年期间，导致 FDA 批准乳腺癌的关键临床试验中，种族和族裔报告没有显著差异。与白人、西班牙裔和亚洲患者相比，黑人患者在这些关键试验中的代表性不足。整个研究期间，族裔报告仍然很低。需要创新方法来确保新型治疗方法的公平受益。
