Department of Pediatrics, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA.
Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA.
Pediatr Blood Cancer. 2024 May;71(5):e30925. doi: 10.1002/pbc.30925. Epub 2024 Feb 26.
Normal absolute neutrophil count (ANC) variations, as seen with Duffy-null associated neutrophil count (DANC), are not accounted for in trial eligibility, which may contribute to racial enrollment disparities. We describe ANC eligibility for pediatric oncology phase I/II clinical trials according to primary sponsorship from 2010 to 2023 using ClinicalTrials.gov. Out of 438 trials, 20% were industry-sponsored. Total 17% of trials required ANC ≥1500 cells/μL for enrollment; however, industry-sponsored trials were significantly more likely to require ANC ≥1500 cells/μL than non-industry-sponsored trials (odds ratio 2.53, 95% confidence interval: 1.39-4.62; p < .001). These data suggest laboratory exclusion criteria are one possible mechanism for pediatric clinical trial enrollment disparities.
正常的绝对中性粒细胞计数（ANC）变化，如与达菲阴性相关的中性粒细胞计数（DANC）所见，在试验资格中没有得到考虑，这可能导致了种族入组差异。我们根据主要赞助机构，使用 ClinicalTrials.gov 描述了 2010 年至 2023 年儿科肿瘤学 I/II 期临床试验的 ANC 资格。在 438 项试验中，20%是由工业界赞助的。总共 17%的试验要求 ANC≥1500 个细胞/μL 才能入组；然而，与非工业界赞助的试验相比，工业界赞助的试验更有可能要求 ANC≥1500 个细胞/μL（比值比 2.53，95%置信区间：1.39-4.62；p<.001）。这些数据表明，实验室排除标准是儿科临床试验入组差异的一个可能机制。
