Diverse populations and enrollment in pediatric cancer clinical trials: Challenges and opportunities

Abstract

Survival rates for pediatric cancer have improved significantly over the past five decades, 1 mainly due to clinical trial (CT) participation. 2 Hispanic children have a significantly higher incidence of leukemia and lymphoma; however, Hispanics and African Americans have poorer 5-year overall survival rates than their non-Hispanic White (NHW) counterparts. 3-5 Lower survival rates are at least partially attributable to lower enrollment in CTs. 6 The National Institutes of Health Revitalization Act of 1993 mandated the inclusion of women and minorities in CTs. 7 However, to date, only 2% of approximately 10 000 National Cancer Institute (NCI) CTs have sufficient minority participants. 8 Despite the NCI's efforts to include minorities in research, Hispanics and African Americans are severely underrepresented compared to NHWs (1-7% and 15% vs 67%, respectively). 8 Enrollment rates in cancer CTs are even lower at 0.4-2.2% for Hispanics and 5.4% for African Americans, even at NCI-designated cancer centers. 8 Our work demonstrated that Hispanics are underrepresented in pediatric cancer research. 9 Consequently, cancer outcomes data are primarily based on data from NHWs, providing inadequate information to adequately assess treatment benefits for minorities.

Disparities in Pediatric Oncology: The 21st Century Opportunity to Improve Outcomes for Children and Adolescents With Cancer

“…Research is scarce on the factors that affect informed consent during enrollment of patients from minority groups in pediatric cancer clinical trials. 53,54 Studies indicate that barriers to adequate informed consent limit minority child and adolescent participation in clinical trials. 40,55,56 True informed consent is deemed valid and meaningful if competence, information disclosure, comprehension, and voluntariness are effectively satisfied.…”

“…60 Federal law requires that children and adolescents have parental informed consent to participate in research, but no mandates ensure voluntariness or comprehension of the information received. 53 Recruitment into pediatric cancer clinical trials often occurs under tremendous emotional stress because of the life-threatening nature of cancer and the need to start treatment promptly. This may hinder comprehension of the informed consent, parental decision-making abilities to weigh the benefits and risks in research, and voluntariness of participation in the clinical trial, 61 particularly in those with limited health literacy.…”

Improving Health Equity and Reducing Disparities in Pediatric and Adolescent/Young Adult Oncology: In Support of Clinical Practice Guidelines

“…20 Even before workup, studies demonstrate that patients who are non-White, economically disadvantaged, or publicly insured frequently present with advanced-stage disease. [21][22][23][24] In a registry analysis of 58,000 AYAs, having public or no insurance was associated with progressively higher odds of late stage at presentation for nearly all cancer sites. 25 In analyses of patients with HL, there was a 2fold increased risk of death due to advanced stage.…”

Role of implicit bias in pediatric cancer clinical trials and enrollment recommendations among pediatric oncology providers

“…Despite these benefits, enrollment rates are variable and range from <20% to 86% 2‐4 . Known barriers to enrollment include structural challenges such as trial availability, clinical barriers such as eligibility restrictions, patient‐level obstacles including travel and financial concerns, and provider‐level concerns including time constraints and implicit bias 3,5,6 …”