The Clinical Trials Gap for Adolescents and Young Adults with Cancer: Recent Progress and Conceptual Framework for Continued Research.

Over the past 30 years, adolescents and young adults (AYA, 15-39 years of age) with cancer have shown significantly less improvement in survival than younger and older patients. Because evidence suggests this may be related to their low participation in cancer clinical trials, increasing accrual to these trials has become a priority for closing this "AYA gap." This paper reviews data documenting low AYA enrollment, presents a conceptual framework for research and intervention (Clinical Trials Pathway to Enrollment) and summarizes recent developments in the United States National Cancer Institute-sponsored clinical trials enterprise that are expected to improve AYA enrollment, including the National Clinical Trials Network (NCTN) and expanded scientific collaboration between the Children's Oncology Group and adult NCTN groups. While time will be required for the effects of these changes to be fully realized, they offer a mechanism for facilitating the breadth of clinical/translational research needed for advancing AYA oncology and measuring its impact.