609 Demographic and clinical factors that contribute to clinical study enrollment

Abstract

Background/purpose Participation in clinical trials is part of the treatment algorithm for many patients with chronic diseases. However, patients with systemic lupus erythematosus (SLE), especially those of African-American and Hispanic descent have been reluctant to participate in clinical trials. Qualitative research identified patient, provider, community, and study design factors as the main reasons for this hesitancy. Concerted efforts to increase awareness and education about SLE clinical trials are underway. We evaluated factors associated with challenges to clinical trial enrollment in the Columbia University Lupus Cohort (CU). Methods A six-session educational intervention modeled after the Lupus Research Alliance Patient Advocates for Lupus Studies (PALS) program and sponsored by the Department of Health and Human Services -Office of Minority Health is currently underway. The target enrollment is 200 patients from 3 New York City cohorts that include large numbers of disparate patients. SLE patients from CU, mostly from the Washington Heights area of New York City, were invited to participate during routine clinic visits. The patients were appraised of the study in detail and their decision to participate or refuse was recorded. Socio-demographics and disease characteristics were collected. Data from recent therapeutic clinical trial participants was included for comparison. Oneway ANOVA was used to detect differences among the 3