Representation of Women and Historically Underserved Populations in Hypertension and Diabetes Clinical Trials at Federally Qualified Health Centers: A Systematic Review and Meta-Analysis

Introduction: Federally Qualified Health Centers (FQHCs) serve diverse populations and may enhance participant diversity in clinical trials; however, their engagement in trials remains understudied.The objective of the current study was to examine participant diversity in hypertension and type-2 diabetes (T2D) clinical trials.Methods: We searched PubMed, Cochrane, CINAHL (Cumulative Index of Nursing and Allied Health Literature), Web of Science, Embase, and Scopus for clinical trial of medical interventions addressing hypertension or T2D among adults (≥18), engaging one or multiple FQHCs, and published between 2013 and 2023.We reported pooled proportions of representation of underserved populations in clinical trials.Results: Of 4552 articles identified, 26 clinical trials were included.The pooled proportion was 0.35 (95% CI: 0.26, 0.45) for Hispanic, 0.36 (95% CI: 0.23, 0.48) for Black/African American, 0.03 (95% CI: 0.02, 0.05) for Asian, 0.58 (95% CI: 0.54, 0.63) for female, and 0.25 (95% CI: 0.07, 0.43) for uninsured participants, and 0.54 (95% CI: 0.36, 0.72) for people with limited education (≤High school). Conclusion: Trials involving FQHCs demonstrated high inclusion of historicallyunderrepresented than typical trial populations.This underscores the potential of FQHCs to improve clinical trial representativeness and to enhance the generalizability of research findings.