Enrollment of adolescent and young adult patients newly diagnosed with cancer in NCI CTEP-sponsored clinical trials before and after launch of the NCI National Clinical Trials Network

Abstract

Background: Participation of adolescents and young adults (AYAs) in oncology clinical trials is important to ensure adequate opportunities for AYA patients to contribute to, and benefit from, advances in cancer treatment.

Methods: Accrual data for National Cancer Institute (NCI) Cancer Therapy Evaluation Program (CTEP) cooperative group-led treatment trials were examined to assess enrollment of newly diagnosed AYA patients (15-39 years) during the period 2004-2019, with particular interest in comparing enrollment before launch of the NCI National Clinical Trials Network (NCTN) to after. All phase 2, 2/3, and 3 trials activated during the period between January 1, 2004, and December 31, 2019, were identified (n = 1568) and reduced to a set of 304 that met predetermined criteria to focus on cooperative group-led trials that involved therapy for newly diagnosed cancer and had age eligibility overlapping the AYA range. The proportion of AYA patients relative to total accrual, along with 95% bootstrapped CI was calculated for patients enrolled pre-NCTN and post-NCTN.

Results: AYA accrual comprised 9.5% (95% CI, 7.6-11.8) pre-NCTN compared with 14.0% (95% CI, 9.9-18.3) post-NCTN. The mean difference in proportions post-NCTN compared with pre-NCTN was 4.4% (0.7%-8.3%).

Conclusions: These results indicate an increase in AYA participation in trials conducted within the NCTN relative to the pre-NCTN period. This suggests an awareness and utilization of NCTN trials for AYAs with cancer.

Keywords: National Cancer Institute National Clinical Trials Network (NCTN); adolescent and young adult (AYA); cancer treatment clinical trial; clinical trial accrual; clinical trial participation; clinical trial trends; oncology clinical trial.

Figure 1

CONSORT 2010 flow diagram.^{a a}Although the objective of this study is to provide a summary of data across many clinical trials rather than reporting a single trial, this diagram indicating criteria for inclusion and inclusion of individual trials has been patterned after the CONSORT flow diagram.

Figure 2

Distribution of trial types by year. For each calendar year, the number of actively accruing trials for which adolescent and young adult patients were eligible is represented as a stacked bar plot. For example, if a trial was activated in 2014 and closed to accrual in 2018, that trial contributes to calendar years 2014–2018. The vertical black bar represents the year of the National Clinical Trials Network launch.

Figure 3

Proportion of AYA patients relative to total accrual enrolled by year. (A) Total number of newly diagnosed patients enrolled from 2004 to 2019 for included trials. (B) Percentage of AYA patients for each calendar year, which was calculated using the number of AYA patients accrued on all included trials for that calendar year divided by the total accrual for those trials in that calendar year. Because only trials activated after January 1, 2004, are included, the first few years in the bar graph may not be representative of the patients accrued those respective years because patients enrolled on a trial that activated before 2004 would not be included. The vertical black bar represents the year of the NCTN launch. AYA indicates adolescent and young adult; NCTN, National Clinical Trials Network.