To investigate the distribution of systemic antifungal trials and the demographics of local populations affected by invasive fungal infections (IFIs) in the US.
Approach:
Key Findings:
Twenty-seven antifungal clinical trials identified across 249 unique sites, with a median enrollment of 88 participants per trial.
Trial sites predominantly located in urban areas; 99.3% of populations around treatment sites and 98.6% around prophylaxis sites resided in metropolitan areas.
Racial minority groups were more represented in immediate and extended catchments of prophylaxis sites compared to the US population (SMD ZCTA, 0.61; 30 miles, 0.28).
A higher proportion of residents with incomes below 150% of the federal poverty level lived in immediate catchment areas compared to the overall US population (SMD treatment, 0.17; prophylaxis, 0.35).
Significant vehicle availability issues were noted, with 46.8% of treatment and 66.9% of prophylaxis catchment residents having fewer vehicles than household members.
Interpretation:
The concentration of IFI trial sites in metropolitan areas may lead to underrepresentation of diverse populations affected by invasive fungal infections, particularly in rural regions with significant disease burden.
Limitations:
Lack of participant-level data prevented analysis of trial demographics and indirect costs, limiting the understanding of how these factors influence trial participation.
Descriptive approach limits the ability to draw causal conclusions.
Conclusion:
The findings highlight the need for strategies to ensure equitable participation and access in clinical trials, capturing disease diversity to advance antifungal drug development, particularly in underserved rural populations.
