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

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.

Keywords: clinical trials; disparities; outcomes research; pediatric oncology; race/ethnicity.

Figure 1. Flow chart of clinical protocol enrollment in any protocol at Rady Children’s Hospital San Diego, 2008–2012

^a Protocol not available- No protocol available for the specific disease, no protocol open at RCHSD, no consents available in the language of the parent. ^b Parent who is considering transfer of care to another country – Parents who were not presented with clinical trial protocols due to ineligibility for enrollment given patient’s country of residency other than the U.S. ^c Parent declined – Parents who were presented with a protocol who refused to participate. ^d Physician perceived barrier - The physician’s decision not to present research trial information due to perceived language and/or cultural barriers. ^e Critical clinical status - The physician’s decision not to present research trial information due to the patient’s critical physical health status. ^f Research Center logistics – Coordination and/or scheduling conflicts, lack of time, lack of personnel.

Figure 2

Trends in enrollment in any protocol by year of diagnosis and race/ethnicity at Rady Children’s Hospital San Diego, 2008–2012