Disparities in pediatric acute myeloid leukemia (AML) clinical trial enrollment.
Lena E WinestoneKelly D GetzPooja RaoYimei LiMatt HallYuan-Shung V HuangAlix E SeifBrian T FisherRichard AplencPublished in: Leukemia & lymphoma (2019)
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.
Keyphrases
- clinical trial
- end stage renal disease
- chronic kidney disease
- acute myeloid leukemia
- ejection fraction
- prognostic factors
- newly diagnosed
- type diabetes
- health information
- patient reported outcomes
- palliative care
- mesenchymal stem cells
- healthcare
- coronary artery disease
- phase ii
- metabolic syndrome
- adipose tissue
- allogeneic hematopoietic stem cell transplantation
- replacement therapy
- affordable care act
- social media
- smoking cessation