Effect of Social Determinants of Health on Clinical Trials Conducted for Diabetic Foot Ulcer and Venous Leg Ulcer at a Safety Net Hospital

Background. Failure to adhere to study protocol is among the most common observations during inspections conducted by competent authorities for clinical trials. Objective. To evaluate patterns of protocol deviations, and to analyze how social determinants of health (SDoH) correlate with the rate of protocol deviations as indicators of study protocol noncompliance. Materials and Methods. Data obtained at a single clinical site from 19 clinical trials with a total of 186 subjects enrolled were analyzed retrospectively, and correlations between SDoH (eg, race/ethnicity, gender [eg, male/female], socioeconomic status, distance traveled, etc) and study protocol noncompliance (ie, rate of deviations) were examined. The Kruskal-Wallis test was performed to compare SDoH variables with rate of deviations per subjects enrolled....