Paediatric drugs trials in China
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...
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| Format: | Article |
| Language: | English |
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BMJ Publishing Group
2020-02-01
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| Series: | BMJ Paediatrics Open |
| Online Access: | https://bmjpaedsopen.bmj.com/content/4/1/e000618.full |
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| author | Wei Zhao Wei Guo Guo-Xiang Hao Xiao-Xiao Yuan Xi-Yu Quan Xue-Jie Qi Tian-You Wang |
| author_facet | Wei Zhao Wei Guo Guo-Xiang Hao Xiao-Xiao Yuan Xi-Yu Quan Xue-Jie Qi Tian-You Wang |
| author_sort | Wei Zhao |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-ecbcbfc8d9154c5383ef1a162186b8c1 |
| institution | Kabale University |
| issn | 2399-9772 |
| language | English |
| publishDate | 2020-02-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Paediatrics Open |
| spelling | doaj-art-ecbcbfc8d9154c5383ef1a162186b8c12024-12-01T01:25:09ZengBMJ Publishing GroupBMJ Paediatrics Open2399-97722020-02-014110.1136/bmjpo-2019-000618Paediatric drugs trials in ChinaWei Zhao0Wei Guo1Guo-Xiang Hao2Xiao-Xiao Yuan3Xi-Yu Quan4Xue-Jie Qi5Tian-You Wang611NMPA Key Laboratory for Clinical Research and Evaluation of Innovative Drug, Qilu Hospital of Shandong University, Shandong University, Jinan, ChinaBeijing Institute of Clinical Medicine, Beijing, China3Department of Clinical Pharmacy, Key Laboratory of Chemical Biology (Ministry of Education), School of Pharmaceutical Sciences, Cheeloo College of Medicine, Shandong University, Jinan, China1 Department of Clinical Pharmacy, School of Pharmaceutical Sciences, Shandong University, Jinan, China1 Department of Clinical Pharmacy, School of Pharmaceutical Sciences, Shandong University, Jinan, China1 Department of Clinical Pharmacy, School of Pharmaceutical Sciences, Shandong University, Jinan, China2 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, ChinaObjective 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.https://bmjpaedsopen.bmj.com/content/4/1/e000618.full |
| spellingShingle | Wei Zhao Wei Guo Guo-Xiang Hao Xiao-Xiao Yuan Xi-Yu Quan Xue-Jie Qi Tian-You Wang Paediatric drugs trials in China BMJ Paediatrics Open |
| title | Paediatric drugs trials in China |
| title_full | Paediatric drugs trials in China |
| title_fullStr | Paediatric drugs trials in China |
| title_full_unstemmed | Paediatric drugs trials in China |
| title_short | Paediatric drugs trials in China |
| title_sort | paediatric drugs trials in china |
| url | https://bmjpaedsopen.bmj.com/content/4/1/e000618.full |
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