Absolute neutrophil count clinical trial eligibility criteria for pediatric oncology phase I and phase I/II trials by sponsorship

Abstract

AbstractNormal 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.