Objective: To retrieve and analyze the registration and development of clinical trials of children’s drugs in China

so as to provide reference for the research and development of children’s drugs. Methods: By retrieving publicly available information of clinical trials of children’ s drugs on the platform of registry and publicity of drug clinical trials from Sept. 6th

2013 to Apr. 19th

2022

statistical analysis was conducted on trial status

indications

initial disclosure dates

types of investigational drugs and sponsor information. Results: A total of 207 clinical trial registration projects of children’ s drugs were retrieved. The number of registered clinical trials of children’s drugs showed an overall increasing trend over time. Clinical trials of children’s drugs were mostly conducted domestically

with international multi-center projects accounting for a relatively low proportion over the past decade ( 16. 9%). In China

Jiangsu had the highest number of registered clinical trial projects by sponsors

and Beijing Children’s Hospital

Capital Medical University led the most clinical trials of children’ s drugs. The majority of clinical trials of children’ s drugs had sample sizes ranging from 200 to 1

000 participants (43. 5%). The field of clinical trials of children’s drugs had the highest number of projects in the area of pre-treatment for children’s respiratory system diseases. Conclusion: The number of clinical trials of children’s drugs in China has been increasing year by year

yet the proportion of international multi-center trials remains relatively low. The field of research in children’s drug clinical trials is relatively limited

which primarily focus on traditional treatments for respiratory system diseases in children.