AI Article Synopsis
- Normal variations in absolute neutrophil count (ANC), particularly related to Duffy-null neutrophil counts, are overlooked in eligibility requirements for clinical trials, potentially leading to racial disparities in enrollment.
- A study analyzing pediatric oncology trials from 2010 to 2023 found that 20% of the 438 trials were industry-sponsored, with 17% of all trials requiring an ANC of at least 1500 cells/μL for participation.
- Industry-sponsored trials were significantly more likely to impose this ANC requirement compared to non-industry trials, indicating that such exclusion criteria might contribute to unequal representation in pediatric clinical research.
Article Abstract
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.
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| http://dx.doi.org/10.1002/pbc.30925 | DOI Listing |
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