免疫检查点抑制剂临床试验中少数种族和族裔群体的代表性不足和报告不足。
Under-Representation and Under-Reporting of Minoritized Racial and Ethnic Groups in Clinical Trials on Immune Checkpoint Inhibitors.
发表日期:2024 Aug 22
作者:
Alfredo V Chua, Jennifer Delmerico, Haiyang Sheng, Xin-Wei Huang, Emily Liang, Li Yan, Shipra Gandhi, Igor Puzanov, Prantesh Jain, Lori C Sakoda, Gary R Morrow, Christine B Ambrosone, Charles Kamen, Song Yao
来源:
Immunity & Ageing
摘要:
历史上,少数种族/族裔群体在癌症临床试验中的代表性不足,最近的免疫检查点抑制剂(ICIs)试验可能会加剧这种情况。我们检查了 ICI 临床试验参与者种族/民族构成的代表性和报告。我们检查了 2007 年至 2022 年发表的 ICI 英文全文试验。有关试验特征和参与者种族/民族构成的信息摘自已发表的论文或 ClinicalTrials.gov。分析了不同发表年份、ICI 药物和癌症部位的参与差异。计算入组发病率 (EIR),以将美国试验中少数种族/族裔群体患者的比例与美国人口的年龄调整癌症发病率数据进行比较。 EIR > 1 表示代表性过高,而 EIR <1 则表示代表性不足。 在所检查的 471 项试验中,有 146 项试验 (31%) 未报告种族构成,而 278 项试验 (59%) 未报告西班牙裔/拉丁裔种族。只有 30 项 (6%) 试验报告了特定种族/民族的结果。在仅限美国的试验中 (n = 174),白人患者的代表性过高(EIR,1.20 [95% CI,1.17 至 1.22]),而西班牙裔/拉丁裔患者的代表性最低(EIR,0.35 [95% CI,1.17 至 1.22]) CI,0.24 至 0.48]),其次是黑人/非裔美国人患者(EIR,0.66 [95% CI,0.54 至 0.79])。亚组分析一致表明,在不同的出版年份(EIR,1.19-1.24)、ICI 类别(EIR,1.16-1.23)和癌症部位(EIR,1.11-1.31)中,白人患者的比例过高,而西班牙裔/拉丁裔患者的比例始终低于-代表。随着时间的推移,所有少数种族/族裔群体的试验代表性和报告均呈上升趋势(趋势 P 值≤0.05)。最近的 ICI 试验中,少数种族/族裔群体的代表性和报告仍然存在差异,需要共同努力改善多样性和公平的癌症治疗机会。
Minoritized racial/ethnic groups are historically under-represented in cancer clinical trials, which may be exacerbated in recent trials on immune checkpoint inhibitors (ICIs). We examined the representation and reporting of the racial/ethnic composition of participants in clinical trials on ICIs.We examined English full-text trials on ICIs published from 2007 to 2022. Information on trial characteristics and racial/ethnic composition of participants was extracted from published papers or ClinicalTrials.gov. Differences in participation by publication year, ICI agent, and cancer site were analyzed. Enrollment-incidence ratio (EIR) was calculated to compare the proportion of minoritized racial/ethnic group patients in US-based trials against age-adjusted cancer incidence data available for the US population. An EIR > 1 signified over-representation, whereas an EIR <1 signified under-representation.Of the 471 trials examined, racial composition was unreported in 146 (31%), whereas Hispanic/Latinx ethnicity was unreported in 278 (59%). Only 30 (6%) trials reported race/ethnicity-specific results. In US-only trials (n = 174), White patients were over-represented (EIR, 1.20 [95% CI, 1.17 to 1.22]), whereas Hispanic/Latinx patients were the most under-represented (EIR, 0.35 [95% CI, 0.24 to 0.48]), followed by Black/African American patients (EIR, 0.66 [95% CI, 0.54 to 0.79]). Subgroup analyses consistently indicated over-representation of White patients across publication years (EIR, 1.19-1.24), ICI classes (EIR, 1.16-1.23), and cancer sites (EIR, 1.11-1.31), whereas Hispanic/Latinx patients were consistently under-represented. An upward trend of trial representation and reporting was observed for all minoritized racial/ethnic groups over time (trend P values ≤.05).Disparities in the representation and reporting of minoritized racial/ethnic groups persist in recent trials on ICIs, necessitating collaborative efforts for improved diversity and equitable cancer treatment access.