Current Situation of Clinical Trials of Drugs for Children's Indications
in China
Abstract
Objective: To analyze the current situation of clinical trials of drugs
with indications for children in China in order to provide references
for research and development of drugs for children and in formulating
relevant policies. Methods: Drug clinical trials with indications for
children registered before January 9, 2020 were retrieved based on the
drug clinical trial registration and information publicity platform. The
data were extracted and statistically analyzed by excel 2010 and SPSS
22.0, respectively. Results: There were 256 clinical trials of drugs
with indications for children, which accounted for 2.61% of the total
registered trials. The overall average annual growth rate of the number
of trials from 2007 to 2019 was 43.30% (P=0.0000). The host company and
the lead organization were mainly located in the eastern and northern
parts of China. There were 67 trials (26.17%) with children as
subjects; 102 trials (39.84%) with research drugs only for children;
the drug type was mainly the chemical drug, and indications mainly
included infections, nervous and mental diseases and respiratory
diseases. Conclusion: The prospects associated with pediatric drug
development are positive, but it still needs new incentives or technical
guidance to further promote.