Abstracts

Rationale: Past research indicates that minority status and socioeconomic disadvantage prevent patients from enrollment in clinical trials and limit access to novel therapies. Researchers have begun systematic research examining the efficacy of cannabis derivatives for epileptic seizure control. This study aimed to assess the enrollment of minorities and patients experiencing socioeconomic constraints in an epilepsy cannabidiol (CBD) study. Methods: Baseline social data were collected from patients with refractory epilepsy enrolled in the University of Alabama at Birmingham CBD Program between 4/1/2015 and 1/12/2017 (N=127) using standardized questionnaires. Comparison was conducted in patient enrollment between Year 1 (4/2015-3/2016) and Year 2 (4/2016-1/2017) of the study. Minority status was defined as black, black-white biracial, or Hispanic versus white/other. Socioeconomic constraints were assessed with family income < $40,000/year and financial strains in terms of money situation (ranging from “Comfortable with extra” to “Cannot make ends meet”) and problems with food availability and paying for epilepsy medications (“sometimes or often” vs. “never”).  Bivariate analyses included cross-tabulations and Pearson correlations (alpha=0.05). Results: The majority of patients (64%) were enrolled in Year 1 of the study (Table 1). About 10% of the study participants were black/biracial/Hispanic, 31% had incomes < $40,000/year, 24% reported money strain, and 17% and 8%, respectively, reported problems with purchasing food and epilepsy medications. The minority enrollment increased (6% to 17%) between the years, with the difference approaching statistical significance (p=0.089; Table 2). The enrollment of low-income patients increased significantly (24% to 44%; p=0.031) while the association between financial strain and study year approached statistical significance (r=0.159; p=0.080). There was no association between food and medication-related constraints and study year. Conclusions: Few minority and low-income patients enrolled in the initial phase of the study, suggesting better/more rapid access to clinical studies and novel therapies for white and higher-income patients. However, over time the access appeared to ease with the enrollment being more inclusive, but still showing disparities. Since epilepsy rates are disproportionally higher and treatment and research participation more restricted among minorities and low-income individuals compared with whites, stronger outreach to underrepresented groups is needed to reduce the gaps. Funding: GW Pharmaceuticals provided the CBD medication free of charge to the patients in the study.