Participation in pediatric oncology research protocols: Racial/ethnic, language and age‐based disparities

Aristizabal, Paula; Singer, Jenelle; Cooper, Renee; Wells, Kristen J.; Nodora, Jesse; Milburn, Mehrzad; Gahagan, Sheila; Schiff, Deborah E.; Martinez, Maria E.

doi:10.1002/pbc.25472

Cited by 106Ethics in Clinical ResearchGlobal Cancer Incidence and ScreeningAcute Lymphoblastic Leukemia research

Participation in pediatric oncology research protocols: Racial/ethnic, language and age‐based disparities

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Aristizabal, Paula, Singer, Jenelle, Cooper, Renee, Wells, Kristen J., Nodora, Jesse, Milburn, Mehrzad, Gahagan, Sheila, Schiff, Deborah E. +1 more·2015·Pediatric Blood & Cancer

DOI 10.1002/pbc.25472PMC PMC4482802

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Abstract

Background: Survival rates in pediatric oncology have improved dramatically, in part due to high patient participation in clinical trials. Although racial/ethnic inequalities in clinical trial participation have been reported in adults, pediatric data and studies comparing participation rates by socio‐demographic characteristics are scarce. The goal of this study was to assess differences in research protocol participation for childhood cancer by age, sex, race/ethnicity, parental language, cancer type, and insurance status. Procedure: Data on enrollment in any protocol, biospecimen, or therapeutic protocols were collected and analyzed for newly diagnosed pediatric patients with cancer from 2008–2012 at Rady Children's Hospital. Results: Among the 353 patients included in the analysis, 304 (86.1%) were enrolled in any protocol. Enrollment in biospecimen and therapeutic protocols was 84.2% (261/310) and 81.1% (206/254), respectively. Logistic regression analyzes revealed significant enrollment underrepresentation in any protocol for Hispanics compared to Non‐Hispanic whites (81% vs. 91%; Odds Ratio [OR], 0.43; 95% Confidence Interval [CI], 0.21–0.90; P = 0.021) and among children of Spanish‐speaking vs. English‐speaking parents (78% vs. 89%; OR, 0.45; 95%CI, 0.23–0.87; P = 0.016). Compared to patients aged 0–4 years, significant underrepresentation was also found among patients 15–21 years old (92% vs.72%; OR, 0.21; 95% CI, 0.09–0.48; P < 0.001). Similar trends were observed when analyzing enrollment in biospecimen and therapeutic protocols separately. Conclusions: There was significant underrepresentation in protocol participation for Hispanics, children of Spanish‐speaking parents, and patients ages 15–21. Research is needed to understand barriers to research participation among these groups underrepresented in pediatric oncology clinical trials. Pediatr Blood Cancer 2015;62:1337–1344. © 2015 Wiley Periodicals, Inc.

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Race and ethnicity may adversely influence enrollment in pediatric clinical trials.
“There is also evidence that these factors may adversely influence enrollment in pediatric clinical trials.45”
From SARS-CoV-2 vaccine testing and trials in the pediatric population: biologic, ethical, research, and implementation challenges (2021) · cites this paper as [45]

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Abstract 5048: Racial/ethnic diversity in pediatric oncology clinical trial enrollment at Rady Children's Hospital San Diego
Aristizabal, P., Singer, J., Cooper, R., Milburn, M., Schiff, D. E., & Martı́nez, M. E. (2014) · Cancer Research · doi:10.1158/1538-7445.am2014-5048
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Racial/ethnic diversity in children's oncology clinical trials
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Disparities in Clinical Trial Participation in Children and Adolescent Patients With a Hematologic Malignancy
Monroe, C., Muñiz, J. P., Leong, T. L., Lewis, R. W., & Castellino, S. M. (2025) · Pediatric Blood & Cancer · doi:10.1002/pbc.31641 · Cited by 2 · see citing works
Access to Children’s Oncology Group phase I clinical trials: Racial/ethnic dissimilarities in participation.
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Improving access to pediatric oncology clinical trials: Identifying modifiable enrollment barriers.
Whitmire, R., Wikstrom, D., & Martin, S. C. (2025) · Journal of Clinical Oncology · doi:10.1200/jco.2025.43.16_suppl.e13818

Authors: Aristizabal, P., Singer, J., Cooper, R., Wells, K. J., Nodora, J., Milburn, M., Gahagan, S., Schiff, D. E., & Martinez, M. E.
Affiliations: University of California San Diego (US)
San Diego State University (US)
Moores Cancer Center University of California San Diego La Jolla California
Corresponding author: Aristizabal, Paula
ORCID: Aristizabal, Paula
Wells, Kristen J.
Nodora, Jesse
Gahagan, Sheila
Schiff, Deborah E.
Venue: Pediatric Blood & Cancer
Publisher: Wiley
Published: 2015-03-08
Volume: 62
Issue: 8
Pages: 1337-1344
ISSN: 1545-5009 (ISSN-L)
1545-5017
DOI: 10.1002/pbc.25472
PMC: PMC4482802
OpenAlex: W1892487278
Cited by: 106
References: 43
Citations by year: 2026: 5 · 2025: 14 · 2024: 13 · 2023: 18 · 2022: 11 · 2021: 9 · 2020: 8 · 2019: 6 · 2018: 12 · 2017: 8 · 2016: 2
FWCI: 7.85
Type: journal article
Language: en
Open access: green
www.ncbi.nlm.nih.gov
Licence: onlinelibrary.wiley.com/termsAndConditions#vor (vor)
Locations: Pediatric Blood & Cancer (publishedVersion)
PubMed (publishedVersion)
Europe PMC (PubMed Central) (acceptedVersion)
PubMed Central (acceptedVersion)
eScholarship (California Digital Library) (submittedVersion)
Funders: National Cancer Institute (NCI) Research Supplements (P30CA23100)
The National Institute of Health (NIH) (ULTR000100)
American Cancer Society (ACS) (MRSG-11-102-01-CPPB-ACS/MRSG)
Topics: Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics in Clinical Research
Health Sciences › Medicine › Oncology › Global Cancer Incidence and Screening
Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Acute Lymphoblastic Leukemia research
Keywords: pediatric oncology, clinical trial participation, childhood cancer, racial and ethnic disparities, Hispanic children, language barriers, Spanish-speaking parents, age disparities, adolescent patient, treatment protocols, insurance status, barriers to research participation
MeSH terms: Adolescent, Adult, Antineoplastic Agents, Child, Child, Preschool, Clinical Trials as Topic, Communication Barriers, Female, Health Services Accessibility, Health Services Needs and Demand, Humans, Infant, Infant, Newborn, Health Knowledge, Attitudes, Practice, Male, Neoplasms, Retrospective Studies, Socioeconomic Factors, Patient Selection, Insurance Coverage, Young Adult

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Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.

Statistics and arithmetic are recomputed, not judged.

Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.

What counts as a claim ›How we measure confidence ›How we check this ›

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Participation in pediatric oncology research protocols: Racial/ethnic, language and age‐based disparities

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