Clinical Trial Accrual: Obstacles and Opportunities

Less than 2% of patients diagnosed with cancer participate in a clinical trial in the United States (1). Gynecologic oncology patients do not appear to participate in trials with any more frequently than other cancer types. While gains in progression free survival have continued to improve overall life span for women with advanced gynecologic cancers, more cures have not been realized. Clinical trials, defined by the National Institute of Health as " a research study in which one or more human subjects are prospectively assigned to one or more interventions to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes " (2), are the primary focus for enrollment of most patients with an active malignancy. Clinical research studies such as tissue banks and longitudinal cohort studies provide invaluable data for researchers but require a consenting population and may be overlooked when the focus is on therapeutic intent. Lack of accrual to clinical trials leads to early closure of studies and a waste of critical resources as well as extended periods of enrollment, which can hinder the ability to interpret the results. Stensland et al. reported that 1 in 4 cancer clinical trials were stopped early with 1 in 10 being stopped for poor accrual (3). A panel of experts convened by the NCI and ASCO to discuss barriers to clinical trial enrollment in 2013 (4) cited barriers in three areas as most significant: (1) patient/community, (2) physician/provider level, and (3) site/organizational. Physician/provider level barriers include willingness to refer a patient for study, lack of knowledge about available clinical trials, and concern regarding a patient's ability to participate (4–6). Patient/community barriers have been noted to include being unaware of trial opportunities and complexity and stringency of the protocol (7). But really, in this time of internet and social media, of immediate and total access to seemingly endless information, why are adult patients not enrolling on clinical trials? A large single institution review of clinical trial enrollment noted a dramatic difference in the proportion of pediatric cancer patients enrolled in clinical trials compared to adult (22 vs. 6%) (8). Is this because parents of children with cancer and young adults with cancer are so much better at searching the internet for clinical trial opportunities? Unlikely, this high rate of participation in the pediatric population preceded the internet age. I believe there are two vital differences between the adult and …