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

Lena E Winestone1,2,3,4, Kelly D Getz1,2, Pooja Rao5

  • 1Division of Oncology, The Children's Hospital of Philadelphia , Philadelphia , PA , USA.

Leukemia & Lymphoma
|February 9, 2019
PubMed

Insights

Pediatric oncology clinical trial enrollment shows disparities. Non-Hispanic Black patients, infants, and those from lower poverty areas were less likely to enroll, though outcomes were similar.

Area of Science:

  • Pediatric Oncology
  • Clinical Trial Research
  • Health Disparities

Background:

  • Equal access to clinical trials is crucial for generalizable research findings in pediatric oncology.
  • Previous research indicates potential disparities in clinical trial enrollment among pediatric cancer patients.
  • Understanding these enrollment patterns is key to addressing inequities in cancer research participation.

Purpose of the Study:

  • To evaluate disparities in enrollment on pediatric oncology clinical trials.
  • To assess the relationship between patient characteristics and enrollment on a specific Children's Oncology Group (COG) trial (AAML1031) for pediatric acute myeloid leukemia (AML).
  • To examine the associations between clinical trial enrollment and patient outcomes.

Main Methods:

  • Retrospective analysis of pediatric patients with AML within the Pediatric Health Information System.
  • Assessment of patient characteristics, including race/ethnicity, age, and socioeconomic factors (poverty level of zip code).
  • Statistical evaluation of enrollment rates and comparison of on-therapy and early mortality between enrolled and nonenrolled patients.

Main Results:

  • Non-Hispanic Black patients (30% vs. 61%), infants (34% vs. 58%), and patients from lower poverty zip codes (46% vs. 58%) were significantly less likely to enroll.
  • On-therapy mortality rates were similar between enrolled (7.3%) and nonenrolled (8.9%) patients (p=0.47).
  • Early mortality differences were more pronounced in nonenrolled patients (3.0%) compared to enrolled patients (0.5%) (p=0.03).

Conclusions:

  • Significant disparities exist in enrollment for pediatric AML clinical trials, particularly affecting minority and younger populations, and those from lower socioeconomic backgrounds.
  • While on-therapy mortality was comparable, early mortality suggests potential negative impacts of non-enrollment.
  • Further investigation into the causes of these enrollment disparities is necessary to promote equitable access to pediatric cancer clinical trials.

Keywords:
Clinical trialsdisparitiesenrollmentleukemiaoutcomes researchpediatric oncologyrace/ethnicity

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