The Children's Oncology Group Adolescent and Young Adult Responsible Investigator Network: A New Model for Addressing Site-Level Factors Impacting Clinical Trial Enrollment.

Abstract

Purpose: In the Children's Oncology Group (COG), there is precedent for scientific committees designating institutional Responsible Investigators (RIs) to promote clinical trial enrollment and coordinate related research activities. In response to low enrollment of adolescents and young adults (AYAs) on COG clinical trials, the COG AYA RI Network was established. Leveraging this network, we undertook an initiative to identify site-level factors influencing AYA enrollment. Methods: The overarching goal of the AYA RI Network is to increase AYA enrollment onto COG trials. At each site, RIs highlight AYA disparities, facilitate activation of relevant trials, improve recruitment processes, and expand interactions with medical oncologists. Through a series of monthly national webinars and workshops, participating RIs reported local barriers and facilitators enrolling AYAs. A mixed-methods approach was utilized to determine major themes of factors affecting site-level enrollment. Results: For this report, there were 145 participating RIs representing 122 demographically and geographically diverse sites. There were 13 interactive webinars and 3 symposia involving 25 speakers focused on addressing enrollment barriers. Major thematic categories for site-level barriers were (1) Lack of available trials; (2) Poor communication between pediatric and medical oncology; (3) Logistical constraints to accessing trials; and (4) Need for leadership support, sufficient resources and appropriate policies. Conclusion: The COG AYA RI Network has identified multiple site-level barriers impeding AYA clinical trial enrollment and represents a novel model for developing and implementing appropriate solutions through a nationally coordinated strategy.