Current situation of pediatric clinical trials in China: focus on trials for drug marketing application and administrative approval

作者：Lin Song, Yuntao Jia, Sujuan Ran, Bin Li, Jin Xu, Bennian Huo, Nange Yin, Maolin Ai, Yao Liu · 发表于：BMC Pediatrics · 年份：2022 · DOI：10.1186/s12887-022-03208-2 · 被引用次数：12 · 研究领域：Pharmaceutical studies and practices、Adolescent and Pediatric Healthcare、Ethics in Clinical Research

BACKGROUND: Research and development of pediatric drug faces many difficulties and pediatric clinical trials remain a challenge. Since 2011, a series of measures have been taken to encourage research, development of drugs for pediatric patients in China. In this study, we analyzed pediatric clinical trials conducted in China to provide reference for research and development of pediatric drugs and formulation of relevant policies. METHODS: We conducted a cross-sectional observational study of pediatric trials registered in the Drug Trial Registration and Information Publication Platform before Oct. 31, 2021. All trials that recruited children (under 18 years old as defined in China) were retrieved and general characteristics of the trials and the research drugs were extracted and analyzed. The data were extracted and statistically analyzed by excel 2010 and SPSS 22.0, respectively. RESULTS: There were 588 registered pediatric clinical trials, which accounted for 3.94% of the total registered trials. The overall average annual growth rate of the number of trials from 2013 to 2020 was 14.47% (P < 0.01). Of the 588 trials included, there were 312 trials (53.06%) with only children as subjects, 127 trials (21.60%) with research drugs only for children use, and the median of target subject number was 320 with the range of 8 to 600,000. The sponsors and the principal investigators were mainly located in the eastern and northern China. 325 trials were vaccine trials, and the dosage f...