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.
Keywords: Pediatric patients; Clinical trials; Pediatric
indications; Drug Trial Registration and Information Publication
Platform