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 (N&#3f203 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 .0001, 0.0402, .0001, respectively). The Kruskal-Wallis test demonstrated an association between a higher number of concomitant medications and adverse events (p .0001). It also observed that higher complexity scores were associated with a higher number of dropouts, PDs and AEs (p = 0.0087, 0.0011, 0.0461, respectively). Finally, the Kruskal-Wallis test showed that a higher body mass index (BMI) was associated with more dropouts (p = 0.0164).Discussion: There was an association observed between a higher number of comorbidities, concomitant medications, complexity scores, and BMI≥30 with increased study dropouts, higher number of adverse events and protocol deviations. Examining the root causes of these outcomes, as well as the patient-centric medical management, can improve data integrity and aid risk-based safety and quality management in wound care clinical trials.References:1. Kaliaev A.O., Malikova M.A. Risk-Based Quality and Compliance Management in Clinical Trials with Combination Products in Changing Global Regulatory Environment. Ther Innov Regul Sci. 2020 Jul; 54(4):803-813. doi: 10.1007/s43441-019-00012-6. Epub 2019 Dec 9. PMID: 32557305. 2. Diversity and Inclusion in Clinical Trials. National Institutes of Health (NIH) Policies. Retrieved April 11, 2024. https://nimhd.nih.gov/resources/understanding-health-disparities/diversity-and-inclusion-in-clinical-trials.html 3. FDA Guidance Draft for Industry Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials. April, 2022. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/diversity-plans-improve-enrollment-participants-underrepresented-racial-and-ethnic-populations 4. FDA Guidelines Draft for Industry Enhancing the Diversity of Clinical Trial Populations—Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry. November, 2020. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enhancing-diversity-clinical-trial-populations-eligibility-criteria-enrollment-practices-and-trial