Effect of social determinants of health on clinical trials conducted for diabetic foot ulcer and venous leg ulcer at a safety net hospital.

Abstract

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. Associations between SDoH and deviations were examined using the Spearman correlation test.

Results: A retrospective analysis showed that the majority of deviations were attributed to study visits that had not been performed in a timely manner or were missed, and study procedures that either were not performed or were completed late. The tests demonstrated no statistical significance between age, gender, and race and rates of dropout from the study (P = .1857, P = .3836, and P = .2150, respectively). Increased body mass index was associated with higher dropout rates (P = .0340), which can be an indicator of higher disease burden and an obstacle to trial participation.

Conclusion: Further studies are warranted to investigate how quality in wound care clinical trials can be improved with identification of patients who need more resources based on their SDoH to efficiently mitigate risks, increase access to trials for disadvantaged populations, and improve study protocol compliance.