Current status of maternal and pediatric drug clinical trial institutions in China

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

doi:10.3969/j.issn.1003-3734.2024.22.010

Abstract：Objective:To understand the current situation of the registration of maternal and pediatric drug clinical trial institutions in China.Methods:The Drug Clinical Trial Institution Filing Management System Platform of National Medical Products Administration of China was searched by computer.Institutions that can carry out obstetrics and gynecology or pediatric drug clinical trials(i.e.,"maternal and pediatric drug clinical trial institutions")were included with information of their regions,registration number,institution name,institution level,and registered specialties.Descriptive analysis was used to summarize characteristics of maternal and pediatric drug clinical trial institutions in China.Results:As of June 30,2023,1 357 drug clinical trial institutions had been registered,of which 548 were maternal and pediatric drug clinical trial institutions.Institutions with registered obstetrics and gynecology specialties accounted for 34.05％of the total registrations,while those with pediatric specialties accounted for only 20.71％.The maternal and pediatric drug clinical trial institutions located more in the east and less in the central and western regions,and were mainly tertiary,comprehensive hospitals.Conclusion:There are problems such as uneven regional distribution and insufficient quantity of maternal and pediatric drug clinical trial institutions in China.It is necessary to promote the development of maternal and pediatric drug clinical trials by providing policy incentives to maternal and pediatric drug clinical trial institutions,optimizing the allocation of resources among regions,standardizing supervision and management,etc.,to promote the research and development of maternal and pediatric drugs.