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Paediatric drugs trials in China

Guo-Xiang Hao1, Xiao-Xiao Yuan1, Wei Guo1

  • 1Department of Clinical Pharmacy, School of Pharmaceutical Sciences, Shandong University, Jinan, China.

BMJ Paediatrics Open
|April 29, 2020
PubMed

Insights

Chinese paediatric drug trials have significantly increased, with most being postmarketing, single-centre, and non-blinded. Further innovation and industry support are needed for high-quality clinical research in children.

Area of Science:

  • Pharmacology and Therapeutics
  • Clinical Research
  • Pediatrics

Background:

  • Paediatric drug trials are crucial for rational drug use in children.
  • China faces challenges in conducting paediatric drug trials, with limited data on their registration status.
  • Urgent research is needed to understand the landscape of paediatric clinical trials in China.

Purpose of the Study:

  • To investigate the registration status and characteristics of paediatric drug trials in China.
  • To analyze trends and identify key features of completed and ongoing paediatric clinical trials.
  • To provide insights for improving paediatric drug research in China.

Main Methods:

  • Data were retrieved from Clinical Trial.gov and the Chinese Clinical Trial Registry up to April 22, 2019.
  • Analysis included 15 key items: registration number, funding, disease type, research stage, design, sample size, blinding, and participant age.
  • A total of 1388 paediatric drug trials registered in China were analyzed.

Main Results:

  • A steady increase in paediatric drug trials was observed, exceeding 100 annually after 2012.
  • Most trials were postmarketing (57.6%), single-centre (75.3%), interventional (83.6%), and non-blinded (84.2%).
  • Trials focused on antineoplastic agents (18.3%), anti-infectives (11.2%), and vaccines (11.1%).

Conclusions:

  • Paediatric drug trials in China have progressed significantly in recent years.
  • Encouraging innovative methods and optimizing trial designs are essential for accelerating paediatric research.
  • Stimulating pharmaceutical companies through legislation is vital for conducting high-quality paediatric clinical trials.
Abstract

Keywords:
evidence based medicinepaediatric practice

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