An analysis of drug clinical trials for women and children in China

ZHANG Pu-wen; DIAO Sha; LIU Zheng; YANG Nan; HE Si-yi; YU Qin; ZENG Li-nan; ZHANG Ling-li

doi:10.3969/j.issn.1003-3734.2024.22.011

Abstract：Objective:To analyze the current status of drug clinical trials for women and children in China and discuss the dilemma.Methods:Information about drug clinical trials for women and children was searched from the explicitly labeled platform of the Center for Drug Evaluation of the National Medical Products Administration by 30 June,2023.The category of drug,clinical trial stage,trial status,and indications were extracted.Besides,the indications were classified by ICD-11.Then,the frequency and component ratio were calculated by descriptive analysis method.Results:In total 1174 clinical trials(5.7％of all registered trials)were included.They had an increasing tendency with the average annual growth rate of 13.4％.They consisted of 994 gynaecology and obstetrics drug clinical trials and 213 paediatrics drug clinical trials.Chemical drugs accounted for the largest proportion of drug clinical trials in gynaecology and obstetrics(87.5％)while biological agents accounted for the largest proportion in paediatrics(41.0％).Chinese medicine/natural medicine clinical trials accounted for the least proportion,accounting for 1.6％of gynaecology and obstetrics drug clinical trials and 21.6％of paediatrics drug clinical trials.Bioequivalency studies for gynaecology and obstetrics drugs accounted for the largest proportion(68.5％),while phase IV clinical trials hold the smallest(1.3％).For paediatrics drug clinical trials,phase Ⅲ clinical trials dominated(44.1％)and bioequivalence trials accounted for the least(0.9％).Besides,the completion rate of drug clinical trials in paediatrics was much lower than that in gynaecology and obstetrics(gynaecology and obstetrics:65.7％;paediatrics:33.8％).In terms of indication,infectious diseases(30.1％)was the most common clinical trials for gynaecology and obstetrics,which was 3.5 times that of the clinical trials of cancer drugs which ranked the second.Clinical trials of paediatric drugs were mainly focused on disease prevention(17.4％)and respiratory diseases(17.4％),which were twice the numbers of endocrine,nutritional or metabolic diseases which ranked the third.Conclusion:The overall number of drug clinical trials for women and children in China has increased year by year.However,there are some problems such as imbalanced distribution of drug types,limited coverage of diseases,and low completion rate of clinical trials for paediatrics drug clinical trials.Thus,it is necessary to further promote the development of drug clinical trials for women and child in the future.