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Current Situation of Clinical Trials of Drugs for Children's Indications in China
  • +6
  • Yao LIU,
  • Lin SONG ,
  • sujuan ran,
  • Bin Li,
  • yuntao Jia,
  • Jing xu,
  • bennian Huo,
  • Nan-ge YIN,
  • molin ai
Yao LIU
Army Medical University
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Lin SONG
National Clinical Research Center for Child Health and Disorders, Ministry of Education Key Laboratory of Child Development and Disorders, China International Science and Technology Cooperation base of Child development and Critical Disorders, Children’s Hospital of Chongqing Medical University, Chongqing
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sujuan ran
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yuntao Jia
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bennian Huo
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Nan-ge YIN
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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.