Disparities in pediatric acute myeloid leukemia (AML) clinical trial enrollment

Abstract

Equal access to clinical trial enrollment is important to ensure that findings are generalizable to the broader population. This study aimed to evaluate disparities in enrollment on pediatric oncology clinical trials. We assessed the relationship between patient characteristics and enrollment on COG trial AAML1031 in a cohort of pediatric patients with AML in the Pediatric Health Information System. The associations of enrollment with outcomes were evaluated. Non-Hispanic Black patients, infants, and patients from zip codes with a lower proportion of poverty were less likely to enroll (30% vs. 61%, p = .004; 34% vs. 58%, p = .003; 46% vs. 58%, p = .02). On-therapy mortality was similar among enrolled and nonenrolled patients (7.3% vs. 8.9%, p = .47). Differences in early mortality were more pronounced among nonenrolled patients compared to enrolled patients (3.0% vs. 0.5%, p = .03). Understanding the etiology of these disparities will inform strategies to ensure balanced access to clinical trials across patient populations.

Keywords:

• Clinical trials
• enrollment
• disparities
• leukemia
• outcomes research
• pediatric oncology
• race/ethnicity

Additional information

Funding

The research group receives support from Dr. Aplenc’s NIH R01CA165277. Dr. Winestone’s effort was supported by the Abramson Cancer Center’s Paul Calabresi Career Development Award for Clinical Oncology [K12CA076931]. Her research is also supported by a Young Investigator Award from Alex’s Lemonade Stand Foundation.