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Evidence Based Medicine
Original research
Paediatric drugs trials in China
  1. Guo-Xiang Hao1,
  2. Xiao-Xiao Yuan1,
  3. Wei Guo1,
  4. Xi-Yu Quan1,
  5. Xue-Jie Qi1,
  6. Tian-You Wang2,3,
  7. Wei Zhao1,4
  1. 1 Department of Clinical Pharmacy, School of Pharmaceutical Sciences, Shandong University, Jinan, China
  2. 2 Beijing Key Laboratory of Paediatric Hematology Oncology, National Key Discipline of Paediatrics (Capital Medical University), Key Laboratory of Major Diseases in Children, Ministry of Education, Beijing, China
  3. 3 Hematology Oncology Center, Beijing Children's Hospital, Capital Medical University, National Center for Children's Health, Beijing, China
  4. 4 Department of Clinical Pharmacy，Clincial Research Center，Department of Paediatrics, The First Affiliated Hospital of Shandong First Medical University, Jinan, China
  1. Correspondence to Professor Wei Zhao; zhao4wei2{at}hotmail.com

Abstract

Objective Clinical trials of children’s drugs are of great significance to rational drug use in children. However, paediatric drugs trials in China are facing complex challenges. At present, the investigation data on registration status of paediatric drug trials in China are still relatively lacking, and relevant research is urgently needed.

Methods The advanced retrieval function is used to retrieve clinical trials data in the Clinical Trial.gov and Chinese Clinical Trial Registry databases in 22 April 2019. Fifteen key items were analysed to describe trial characteristics, including: registration number, study start date (year), mode of funding, type of disease, medicine type, research stage, research design, sample size, number of experimental groups, placebo group, blind method, implementation centre, child specific, newborn specific and participant age.

Results A total of 1388 clinical trials of paediatric drugs conducted in China were registered. The number of paediatric drug trials grew steadily over time, from less than 20 per year before 2005 to more than 100 per year after 2012. Most clinical trials were postmarketing (n=800, 57.6%), single-centre (n=1045, 75.3%), intervention studies (n=1161, 83.6%) without blinded methods (1169, 84.2%) and funded by non-profit organisations (n=838, 60.4%). The number of clinical trials for antineoplastic agents (n=254, 18.3%), anti-infectives (n=156, 11.2%) and vaccines (n=154, 11.1%) is the largest.

Conclusion Paediatric drug trials in China made a significant progress in recent years. Innovative method and trial design optimisation should be encouraged to accelerate paediatric clinical research. Pharmaceutical companies need to be further stimulated to carry out more high-quality paediatric clinical trials with support of paediatric drug legislation.

  • paediatric practice
  • evidence based medicine
http://creativecommons.org/licenses/by-nc/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/bmjpo-2019-000618

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    Footnotes

    • Contributors WZ had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Study concept and design: T-YW and WZ. Acquisition, analysis and interpretation of data: all authors. Drafting of the manuscript: G-xH, X-xY and WZ. Critical revision of the manuscript: all authors. The authors plan to disseminate the results to study participants.

    • Funding This work is supported by National Science and Technology Major Projects for 'Major New Drugs Innovation and Development' (2017ZX09304029-002), Young Taishan Scholars Program of Shandong Province, Qilu Young Scholars Program of Shandong University, National Natural Science Foundation of China (81503163), Medical and Health Science and Technology Development Program of Shandong Province (2018WSB19010).

    • Competing interests None declared.

    • Patient consent for publication Not required.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Data availability statement Data are available upon reasonable request. zhao4wei2@hotmail.com.