Wenwen Wu

and 11 more

Like most areas worldwide, there is a shortage of pediatric drugs in mainland China to provide prescriptions. The Chinese government recently launched policies and incentives to encourage pediatric drug development and clinical trials. However, few data are available on the characteristics or development trends of these trials. We extracted source data from the Chinese Clinical Trials Registry and Information Transparency Platform and systematically reviewed the pediatric clinical trials conducted in mainland China from 2009–2020, providing data support to policy makers and industry stakeholders. This study includes 487 pediatric clinical trials.Over the past decade, the number of pediatric trials has increased annually, especially since 2016.The most common therapeutic areas were infectious diseases (n=108, 22.2%),agents for preventive purpose (n=99,20.3%), and neurological and psychiatric diseases (n=71,14.6%). The number of clinical trials involving epilepsy (39,10.1%), asthma (33,8.5%), and influenza (24,6.2%) were the highest. The distribution of leading institutions is unbalanced in mainland China, with most units in East China (34.0%) and few in Southwest China (6.9%). China has made constant progress in improving the R&D environment of pediatric drugs and increasing pediatric trials. However, a wide gap in pediatric drug development remains between China and developed countries. The pharmaceutical industry in China still faces grim setbacks, including study duplication, a lack of innovation, and poor research design. Thus, the Chinese government should adjust their policies to improve innovation and clinical design capacity, and to optimize resource allocation between regions.