Pediatric cancer trial enrollment declines


Clinical trials have led to many improvements in pediatric cancer survival rates. However, a new study finds that enrollment rates in clinical trials are on the decline.

Clinical trials for cancer have led to many improvements in pediatric cancer survival rates. The number of pediatric cancer patients who enroll in clinical trials has far outpaced the number of adult cancer patients who enroll in similar trials. A new study of pediatric cancer trial enrollment rates examines the decline in patients in the Children’s Oncology Group (COG) trials and what the decline could mean.1

Investigators looked at COG trial participation between 2004 and 2015 using 4 data sources: COG enrollment data; Surveillance, Epidemiology, and End Results (SEER) Program 18 incidence data; US population estimates provided through SEER; and sociodemographic information from the American Community Survey. The final study populations included 114,316 SEER patients.

Extrapolating from SEER data, between 2004 and 2014 there were 414,003 cancer diagnoses in patients aged 0 to 29 years in the United States. Among the diagnoses, solid tumors made up 59% of cases; hematologic malignancies, 29% of cases; central nervous system tumors, 11% of cases, and unidentified disease accounted for 1% of cases. Among pediatric cases, the highest proportion of cases, 14%, was among adolescents aged 15 to 19 years followed by children aged 0 to 4 years at 13%.

During the same period, the number of patients who enrolled in upfront COG trials was 36,683. Boys made up a great portion of the enrolled population (56%) and white participants totaled 59% of enrolled patients. The COG cohort skewed toward the young with 0- to 4-year-olds comprising 39% of participants, 5- to 9-year-olds comprising 24% of participants, 15- to 19-year-olds comprising 17% of participants, and 10- to 14-year-olds comprising 15% of participants. In comparison, 20- to 24-year-olds made up 5% of participants and 25- to 29-year-olds comprised less than 1% of participants. Enrollment in trials increased from 2004-2006 to 2007-2009, but then declined in the 2010-2012 and 2013-2015 time periods.

The investigators concluded that 19.9% of US cancer patients aged 0 to 19 years had enrolled in COG trials between 2004 and 2015. This was a decline from the 26.8% enrollment seen in 2000 to 2003, which itself was a decline from the 40% to 70% seen in the 1990s.


1.    Faulk KE, Anderson-Mellies A, Cockburn M, Green AL. Assessment of enrollment characteristics for Children's Oncology Group (COG) upfront therapeutic clinical trials 2004-2015. PLoS ONE. 2020;15(4):e0230824. doi: 10.1371/journal.pone.0230824

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