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Participation in pediatric oncology research protocols: Racial/ethnic, language and age-based disparities
Paula Aristizabal1,2,3, Jenelle Singer1, Renee Cooper4
1Department of Pediatrics, University of California San Diego, San Diego, California.
Insights
Pediatric cancer patients who are Hispanic, have Spanish-speaking parents, or are adolescents (15-21 years) show underrepresentation in clinical trial participation. Further research is needed to address these disparities in pediatric oncology research.
Area of Science:
- Pediatric Oncology
- Clinical Trial Research
- Health Disparities
Background:
- Pediatric cancer survival rates have improved due to clinical trial participation.
- Existing research highlights racial/ethnic disparities in adult clinical trials.
- Data on socio-demographic factors influencing pediatric trial participation is limited.
Purpose of the Study:
- To assess disparities in pediatric cancer research protocol participation.
- To analyze participation differences based on age, sex, race/ethnicity, parental language, cancer type, and insurance status.
Main Methods:
- Retrospective analysis of newly diagnosed pediatric cancer patients (2008-2012).
- Data collected on enrollment in any protocol, biospecimen, or therapeutic protocols.
- Logistic regression used to identify significant enrollment differences.
Main Results:
- Overall protocol enrollment was 86.1% (304/353).
- Significant underrepresentation observed for Hispanic patients (81% vs. 91% Non-Hispanic white) and children of Spanish-speaking parents (78% vs. 89%).
- Adolescents aged 15-21 were significantly underrepresented (72% vs. 92% for ages 0-4).
Conclusions:
- Hispanic ethnicity, Spanish parental language, and older adolescent age (15-21) are associated with underrepresentation in pediatric cancer clinical trials.
- Barriers to research participation for these underrepresented groups require further investigation.
- Addressing these disparities is crucial for equitable advancement in pediatric oncology.
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.
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