Characteristics Analysis of Pediatric Drug Clinical Trials Registered in Chinese Clinical Trial Registry / 中国药房

ABSTRACT

OBJECTIVE：To provi de reference for standardizing pediatric clinical trials and promoting the development and application of pediatric medication in China. METHODS ：Chinese Clinical Trial Registry （Chi CTR ）database were searched to collect all clinical trials related to pediatric population under 18 years old from the inception to Oct. 1st，2019. Those clinical trials were analyzed statistically in respect of name of registered project ，involved disease/system ，research stage ，registration time ， registration status ，regional distribution of research institutions ，source of funds ，research type ，whether data management committee was set up ，situation of recruited research objects ，ethics committee approval status ，whether blind method was adopted ， whether to collect human specimens and whereabouts of human specimens. RESULTS ：A total of 231 pediatric drug clinical trials were included. The clinical trials involved 21 kinds of diseases/systems ，mainly were tumors and tumor-like lesions ，ophthalmic diseases and allergic disease. The research stage has the most items （85 trials，36.80％）in post-marketing drug clinical trials ；there were 77 items of phase Ⅰ-Ⅳ clinical trials （33.33％）. The number of pediatric drug clinical trials was increased year by year ，and among which 179 trials were pre-registered （77.49％），52 trials were supplementary registration （22.51％）. Beijing ，Shanghai， Guangdong，Chongqing and Zhejiang were the major regions where pediatric drug clinical trials were carried out ，and the clinical trial projects of which accounted for 66.23％（153/231）of the total number of included projects. The funding sources were mainly self-financing（57.85％），hospital finance （20.18％），and local government finance （10.31％）. The main type of research was intervention study and observational study ，accounting for 88.31％ in total. Totally 145 trials（62.77％）had not yet determined whether to set up a data management committee ；201 trials（87.01％）had passed the review of the ethics committee of the relevant institution；168 trials（72.73％）did not clarify whether the blind method was used ；133 trials（57.58％）had collected 001-001） human specimens ，and the collected human specimens were 3360875。E-mail：794446155@qq.com mainly destroyed after use. CONCLUSIONS ：The number of pediatric drug clinical trials registered in Chi CTR is increasing but there i s regional imbalance. Researchers have gradually established the concept of pediatric clinical trial registration ，and have realized the importance of data management to research quality ，and the management of collected trial specimens is relatively standardized. It is suggested that relevant departments increase the publicity of clinical trial registration and improve the clinical trial registration management system ； relevant researchers should increase the awareness of clinical trial registration ，standardize registration application and trial project management.