Enrollment in children’s oncology group’s clinical trials: population-based linkage with the national childhood cancer registry

Abstract

Background Improvements in outcomes among children and adolescents diagnosed with cancer are attributable to many factors—including clinical trials such as those administered through the Children’s Oncology Group (COG), as well as population-based resources like the National Childhood Cancer Registry (NCCR). The objective of this study was to link COG trial data with the NCCR to evaluate overall enrollment patterns. Methods Data were received from the NCCR and COG, which were linked using an array of variables and then compared to evaluate enrollment patterns in COG studies from 2007-2018. Multivariable logistic regression was used to identify characteristics associated with not being enrolled in a COG study. Results Among 134,696 NCCR cancer patients, 51,062 matched with COG study enrollees. There were several differences in demographic and clinical characteristics between those enrolled and not enrolled in COG studies. Enrollment was higher among children aged 0-4 years compared to adolescents aged 15-19 years (53.7% vs 20.1%). Differences by race/ethnicity were also observed; for example, those who identified as non-Hispanic White were more likely to be enrolled than those who identified as non-Hispanic Asian/Pacific Islander (38.8% vs 32.9%). In a multivariable logistic regression model, several characteristics were significantly associated with not being enrolled in a COG study, including age at diagnosis, year of diagnosis, race/ethnicity, and cancer type. Conclusion Our results suggest that several groups are underrepresented in COG clinical trials. This information can help guide the prioritization of population groups for engagement in future studies.