title: 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.
  
  
  METHODS
  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.
authors.affiliation: Department of Pediatrics, University of California San Diego, San Diego, California.|Division of Pediatric Hematology/Oncology, Rady Children's Hospital San Diego, San Diego, California.|Moores Cancer Center, University of California San Diego, La Jolla, California.
authors.forename: Paula
authors.initials: P
authors.lastname: Aristizabal
authors.affiliation: Department of Pediatrics, University of California San Diego, San Diego, California.
authors.forename: Jenelle
authors.initials: J
authors.lastname: Singer
authors.affiliation: Graduate School of Public Health, San Diego State University, San Diego, California.
authors.forename: Renee
authors.initials: R
authors.lastname: Cooper
authors.affiliation: Department of Psychology, San Diego State University, San Diego, California.|Department of Family and Preventive Medicine, University of California San Diego, La Jolla, California.
authors.forename: Kristen J
authors.initials: KJ
authors.lastname: Wells
authors.affiliation: Moores Cancer Center, University of California San Diego, La Jolla, California.|Department of Family and Preventive Medicine, University of California San Diego, La Jolla, California.
authors.forename: Jesse
authors.initials: J
authors.lastname: Nodora
authors.affiliation: Department of Pediatrics, University of California San Diego, San Diego, California.
authors.forename: Mehrzad
authors.initials: M
authors.lastname: Milburn
authors.affiliation: Department of Pediatrics, University of California San Diego, San Diego, California.|Division of Pediatric Hematology/Oncology, Rady Children's Hospital San Diego, San Diego, California.
authors.forename: Sheila
authors.initials: S
authors.lastname: Gahagan
authors.affiliation: Department of Pediatrics, University of California San Diego, San Diego, California.|Division of Pediatric Hematology/Oncology, Rady Children's Hospital San Diego, San Diego, California.
authors.forename: Deborah E
authors.initials: DE
authors.lastname: Schiff
authors.affiliation: Moores Cancer Center, University of California San Diego, La Jolla, California.|Department of Family and Preventive Medicine, University of California San Diego, La Jolla, California.
authors.forename: Maria E
authors.initials: ME
authors.lastname: Martinez
mesh_terms: D000293:Adolescent; D000328:Adult; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D002986:Clinical Trials as Topic / Q000379:methods*; D003144:Communication Barriers; D005260:Female; D007722:Health Knowledge, Attitudes, Practice / Q000208:ethnology*; D006297:Health Services Accessibility; D006301:Health Services Needs and Demand; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D019458:Insurance Coverage; D008297:Male; D009369:Neoplasms / Q000188:drug therapy*; D018579:Patient Selection; D012189:Retrospective Studies; D012959:Socioeconomic Factors; D055815:Young Adult
chemical_list: D000970:Antineoplastic Agents
keywords: clinical trials; disparities; outcomes research; pediatric oncology; race/ethnicity