Impact of social determinants of health on patient safety in wound care clinical trials with combination products.

Introduction: Combination products are increasingly utilized in wound care as innovative biomedical entities that may help to improve patient outcomes. [1] Due to their combined nature, which can potentially increase risks, the FDA has provided specific safety/efficacy guidelines for clinical trials with combination products. [1] The inclusion of patients with different social determinants of health (SDH) is currently expected by the FDA as part of developing patient-centric solutions, achieving diversity and health equity in clinical trials. [2-4] Also, it is important to accurately establish safety and efficacy parameters for future use in post-marketing. [2-4]. The purpose was to evaluate how social determinants correlate with safety events in wounds care clinical trials with combination products in order to identify safety signals, improve safety profile, and develop risk-based safety and quality management strategies.Methods:Retrospective analysis of 14 trials with combination products (Nf203 randomized subjects) was performed to assess the relationship between various SDH (e.g. race, sex, socioeconomic status, primary language, BMI, insurance type, distance traveled, comorbidities, etc.), and adverse events (AEs) and protocol deviations by using the Spearman correlation and Kruskal-Wallis tests.Results:The Kruskal-Wallis and Spearman correlation tests showed that a higher number of comorbidities was associated with a higher number of dropouts, PDs and AEs (p