Wheeler Meghann, Karanth Shama, Divaker Joel, Yoon Hyung-Suk, Yang Jae Jeong, Ratcliffe Maisey, Blair Marissa, Mehta Hiren J, Rackauskas Mindaugas, Braithwaite Dejana
Department of Epidemiology, University of Florida, Gainesville, FL 32603.
Department of Surgery, University of Florida, Gainesville, FL 32610; University of Florida Health Cancer Center, University of Florida, Gainesville, FL 32610.
Clin Lung Cancer. 2025 Jan;26(1):52-57.e2. doi: 10.1016/j.cllc.2024.09.009. Epub 2024 Oct 4.
Despite efforts by Cancer Centers and community organizations to increase diversity in clinical trials, significant racial/ethnic disparities remain. Given the high mortality rates in non-small cell lung cancer (NSCLC), it is important to increase diversity in NSCLC trials, ensuring all patients benefit from advances in new treatment modalities.
We evaluated the distribution of racial/ethnic minority enrollment in NSCLC clinical trials using data from ClinicalTrials.gov. We extracted trial characteristics, including start year, study phase, tumor stage, sample size, sponsor, geographic region, and masking. The number of participants by race/ethnicity was obtained from ClinicalTrials.gov or linked publications. Using annual NSCLC incidence data from SEER*Stat for each racial/ethnic group from 2010 to 2019, we applied a 2-sample test for equality of proportions with continuity correction to assess differences between incidence and trial participation.
A total of 147 unique studies were included in the final analysis. Of the 28,540 participants, 79.6% were White, with 3% Black, 10.4% Asian or Pacific Islander and 3.4% Hispanic/Latino. Most participants were enrolled in phase III trials (63.8%), industry-sponsored (93.9%), and open-label (67.7%). Black patients were more commonly enrolled in academic sponsored trials and less commonly enrolled in masked (i.e., blinded) studies. When comparing trial participation to annual incidence data, we observed underrepresentation among Black participants (Difference: -7.9%) and Hispanic/Latino participants (Difference: -3.2%).
Persistent underrepresentation exists in NSCLC clinical trials among Black and Hispanic/Latino patients. We urge further investigation of these findings through well-designed clinical trials among diverse patient populations.
尽管癌症中心和社区组织努力提高临床试验的多样性，但显著的种族/族裔差异仍然存在。鉴于非小细胞肺癌（NSCLC）的高死亡率，增加NSCLC试验的多样性很重要，以确保所有患者都能从新治疗模式的进展中受益。
我们使用ClinicalTrials.gov的数据评估了NSCLC临床试验中种族/族裔少数群体入组情况的分布。我们提取了试验特征，包括开始年份、研究阶段、肿瘤分期、样本量、申办者、地理区域和设盲情况。按种族/族裔划分的参与者数量来自ClinicalTrials.gov或相关出版物。利用2010年至2019年SEER*Stat针对每个种族/族裔群体的年度NSCLC发病率数据，我们应用了带有连续性校正的两样本比例相等性检验，以评估发病率与试验参与率之间的差异。
最终分析共纳入147项独特研究。在28540名参与者中，79.6%为白人，3%为黑人，10.4%为亚裔或太平洋岛民，3.4%为西班牙裔/拉丁裔。大多数参与者参加III期试验（63.8%），由行业赞助（93.9%），且为开放标签试验（67.7%）。黑人患者更常参加学术赞助的试验，较少参加设盲（即双盲）研究。在将试验参与情况与年度发病率数据进行比较时，我们发现黑人参与者（差异：-7.9%）和西班牙裔/拉丁裔参与者（差异：-3.2%）的入组率不足。
NSCLC临床试验中黑人及西班牙裔/拉丁裔患者的入组率持续不足。我们敦促通过针对不同患者群体精心设计的临床试验对这些发现进行进一步调查。
