Clinical trial enrollment of adolescent and young adult patients with cancer: a systematic review of the literature and proposed solutions

Abstract

Although there has been significant progress in the survival of children and older adults with cancer in the last few decades, this has not been the case for adolescent and young adults (AYAs). Although there are multiple reasons why outcomes for AYAs have not improved over time, it is evident from studies that AYAs fare better when enrolled in clinical trials, yet they are much less likely to participate in trials when compared with children and older adults. The goal of this review is to understand the trends in clinical trial enrollment of AYA patients over time, recognize facilitators and barriers to enrollment, and evaluate methods that have been utilized in order to improve clinical trial enrollment for this group of patients. A systematic review of the literature was performed to search for articles related to AYA oncology and clinical trials. The articles that met all inclusion criteria were then subject to full-text review, which yielded 17 articles that used quantitative, qualitative, or mixed methods. The articles reviewed demonstrated that for AYA patients, survival and clinical trial enrollment have shown some improvement over time, yet participation in clinical trials is still relatively poor, particularly for older patients within this group. Major barriers to enrollment in clinical trials include limited access and availability of trials, as well as patient knowledge. We have introduced the 4 Ps Conceptual “Onion Skin” Model, which includes patient, partners, providers, and policies, with the goal of reducing barriers to trial enrollment. Interventions utilizing this model include the establishment of more AYA centers, increased collaboration among cooperative groups with the goal of creating more AYA-specific trials, and educating patients and providers about the benefits of participating in clinical trials. Further studies are needed to understand which interventions would be most successful in encouraging AYA patients to enroll in clinical trials.