Absolute neutrophil count clinical trial eligibility criteria for pediatric oncology phase I and phase I/II trials by sponsorship.
Jenny RuizRebecca K KellyRichard AplencTheodore W LaetschAlix E SeifPublished in: Pediatric blood & cancer (2024)
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.
Keyphrases
- clinical trial
- phase ii
- induced apoptosis
- phase iii
- study protocol
- affordable care act
- cell cycle arrest
- health insurance
- open label
- palliative care
- peripheral blood
- healthcare
- randomized controlled trial
- double blind
- electronic health record
- machine learning
- oxidative stress
- signaling pathway
- endoplasmic reticulum stress
- cell death
- young adults
- african american