为了确定生殖泌尿系统肿瘤临床试验参与者的种族和民族分布情况，以及被FDA批准使用新型分子实体/生物制品。其次，我们评估了临床试验中黑人参与者的比例是否随时间增加。我们查询了2015年至2020年FDA药物审评中心药物试验快照数据，用于泌尿肿瘤临床试验，这些试验导致了新药的FDA批准。入组数据按种族和民族分层。 Cochran-Armitage趋势检验用于检查黑人患者参与度随着时间的变化。我们确定了9个临床试验，这些试验分别导致了5种前列腺肿瘤分子实体和4种尿路上皮癌治疗分子实体的FDA批准。前列腺癌的试验中包括5202名参与者，其中69.8%是白人，4.0%是黑人，11.0%是亚洲人，3.6%是西班牙裔，<1％是印第安人/阿拉斯加原住民或夏威夷土著/太平洋岛民，3％是其他人。尿路上皮癌的试验中有704名参与者，其中75.1％是男性，80.8％是白人，2.3％是黑人，2.4％是西班牙裔，<1％是印第安人/阿拉斯加原住民或夏威夷土著/太平洋岛民，5％是其他人。随着时间的推移，尿路上皮癌的黑人参与率没有变化（P = 0.59），整个癌症队列的黑人参与率也没有变化（P = 0.29）。前列腺癌的参与者中黑人参与度随时间下降（P = 0.03）。参加生殖泌尿系统临床试验并获得FDA批准的新药的参与者绝大多数是白人。在新药的临床试验设计和实施中涉及代表少数民族利益和需求的利益相关者可能是一种增加生殖泌尿系统临床试验多样性、公平性和包容性的策略。版权所有©2023 Elsevier Inc.。

To determine the distribution of race and ethnicity among genitourinary oncology trial participants leading to FDA approval of novel molecular entities/biologics. Secondarily, we evaluated whether the proportion of Black participants in clinical trials increased over time. We quired the FDA Center for Drug Evaluation and Research Drug Trials Snapshot (DTS) between 2015 and 2020 for urologic oncology clinical trials leading to FDA approval of novel drugs. Enrollment data was stratified by race and ethnicity. Cochran-Armitage Trend tests were used to examine changes in Black patient participation over years. Nine clinical trials were identified that led to FDA approval of 5 novel molecular entities for prostate and 4 molecular entities for urothelial carcinoma treatment. Trials for prostate cancer included 5202 participants of which 69.8% were White, 4.0% Black, 11.0% Asian, 3.6% Hispanic, <1% American Indian/Alaska Native or Native Hawaiian/Pacific Islander, 3% other. Trials in urothelial carcinoma had 704 participants of which 75.1% were male, 80.8% White, 2.3% Black, 2.4% Hispanic, <1% American Indian/Alaska Native or Native Hawaiian/Pacific Islander, 5% other. Black participation rates over time did not change for urothelial (P = 0.59) or the combined cancer cohort (P = 0.29). Prostate cancer enrollment trends among Black participant declined over time (P = 0.03). Participants in genitourinary clinical trials leading to FDA approval of novel drugs are overwhelmingly white. Involving stakeholders who represent the needs and interests of underrepresented populations in the design and implementation of clinical trials of novel agents may be a strategy to increase diversity, equity, and inclusion among genitourinary clinical trials.Copyright © 2023 Elsevier Inc. All rights reserved.