OBJECTIVE  To analyze the current status and design characteristics of antifungal drug clinical trials both domestically and internationally, providing reference for the clinical development of antifungal drugs.

METHODS Data were collected from the China Drug Clinical Trial Registration and Information Disclosure Platform(www.chinadrugtrials.org.cn) and the ClinicalTrials.gov website for antifungal drug clinical trials registered between November 1, 2012, and March 28, 2024. WPS Office software was used for data organization, and trials meeting the inclusion and exclusion criteria were included for analysis.

RESULTS A total of 194 clinical trials from the China Drug Clinical Trial Registration and Information Disclosure Platform and 196 trials from ClinicalTrials.gov were included in the analysis. Compared with ClinicalTrials.gov, the current status of registered antifungal drug clinical trials in China exhibited the following characteristics: ①The number of trial projects had increased annually since 2018, with a notable rise in bioequivalence/bioavailability trials; ②There were fewer investigational drug varieties (29 vs 59), and the emergence of new antifungal drug varieties was limited (7 vs 16); ③A higher proportion of ongoing trials requiring recruitment involve healthy participants(74.19% vs 0.00%). The trial design characteristics of domestic and international studies showed the following features: ①In China, 56.25% of trials for invasive fungal infections used overly stringent diagnostic criteria, specifically the EORTC/MSGERC guidelines; ②In both domestic and international studies, 60% of trials for invasive candidiasis and candidemia had a shorter duration of empirical treatment prior to enrollment compared to the time required for fungal culture and identification; ③A substantial 82.35% of trials for invasive candidiasis excluded cases of invasive deep-seated candidiasis.

CONCLUSION  With the implementation of the registration system, the introduction of new clinical trial institutions has facilitated the conduct of antifungal drug registration trials in China. However, challenges persist, including insufficient research and development of new antifungal drugs and difficulties in recruiting healthy participants. Moreover, there is potential for improvement and further research concerning diagnostic criteria in protocols for invasive fungal infection trial, the duration of empirical treatment prior to enrollment for invasive candidiasis and candidemia trials, and the management of invasive deep-seated candidiasis.