Abstract
BackgroundImprovements in pediatric cancer survival are attributed to cooperative clinical trials. Under-representation of specific demographic groups has been described in adult and pediatric cancer trials and poses a threat to the generalizability of results. An evaluation of data provided by the Children’s Oncology Group (COG) of upfront trial enrollment for US patients 0 to 29 years old between 2004 and 2015 was performed.MethodsUS cancer cases were estimated using incidence data and US population estimates from the Surveillance, Epidemiology, and End Results Program and compared to observed COG cases. Percent enrollment and standardized ratios of enrollment were calculated across demographic, disease, and socioeconomic groups. The COG website was utilized to quantify available trials and assess age eligibility.Results19.9% of estimated US cancer patients age 0 to 19 years enrolled on COG trials. Younger patients were more represented across diseases and races/ethnicities. Patients with hematologic malignancies were more represented compared to solid and central nervous system (CNS) tumors.ConclusionCOG trial enrollment rates are declining when compared to previously published data, potentially from challenges in pediatric drug development, difficulty designing feasible trials for highly curable diagnoses, and issues ensuring trial availability for the heterogeneous group of solid and CNS tumors. Though racial/ethnic groups and county-level socioeconomic factors were proportionally represented, under representation of the adolescent/young adult (AYA) population and younger patients with solid and CNS tumors remains a concern. Targeted efforts should focus on these subgroups and further research should evaluate AYA enrollment rates across all available trials.
Highlights
The improvement in childhood cancer mortality over several decades [1, 2] is attributed to treatment advances from cooperative clinical trials across the United States (US)
Children’s Oncology Group (COG) trial enrollment rates are declining when compared to previously published data, potentially from challenges in pediatric drug development, difficulty designing feasible trials for highly curable diagnoses, and issues ensuring trial availability for the heterogeneous group of solid and central nervous system (CNS) tumors
Compared to adult cancer patients, 1.5–4% of whom enroll, [3, 4] trial participation for young cancer patients is reported to be much higher, with enrollment rates of 27–86%. [2, 3, 5,6,7,8,9,10] Underrepresentation of racial/ethnic minorities in trials has been consistently reported in adult cancer populations, and similar disparities in pediatric and adolescent enrollment have been published with regard to age, race/ethnicity, and cancer diagnosis. [6,7,8,9, 11,12,13,14] previous studies were commonly single institution, were performed decades ago, and have typically focused on adult National Cancer Institute (NCI) trial enrollment; a comprehensive, modern evaluation of pediatric and young adult trial enrollment is needed
Summary
The improvement in childhood cancer mortality over several decades [1, 2] is attributed to treatment advances from cooperative clinical trials across the United States (US). [2, 3, 5,6,7,8,9,10] Underrepresentation of racial/ethnic minorities in trials has been consistently reported in adult cancer populations, and similar disparities in pediatric and adolescent enrollment have been published with regard to age, race/ethnicity, and cancer diagnosis. [5] Given the large scope of COG clinical research, there is a necessary emphasis on equal access to trials and proportional representation of enrolled patients to ensure generalizability of results. An evaluation of data provided by the Children’s Oncology Group (COG) of upfront trial enrollment for US patients 0 to 29 years old between 2004 and 2015 was performed
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