Paediatric drugs trials in China.
evidence based medicine
paediatric practice
Journal
BMJ paediatrics open
ISSN: 2399-9772
Titre abrégé: BMJ Paediatr Open
Pays: England
ID NLM: 101715309
Informations de publication
Date de publication:
2020
2020
Historique:
received:
29
11
2019
revised:
18
01
2020
accepted:
31
01
2020
entrez:
29
4
2020
pubmed:
29
4
2020
medline:
29
4
2020
Statut:
epublish
Résumé
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. 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. 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. 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.
Identifiants
pubmed: 32342015
doi: 10.1136/bmjpo-2019-000618
pii: bmjpo-2019-000618
pmc: PMC7173953
doi:
Types de publication
Journal Article
Langues
eng
Pagination
e000618Informations de copyright
© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
Déclaration de conflit d'intérêts
Competing interests: None declared.
Références
Paediatr Anaesth. 2009 Oct;19(10):989-93
pubmed: 19659675
Arch Dis Child Fetal Neonatal Ed. 2014 Sep;99(5):F438
pubmed: 24792777
Curr Clin Pharmacol. 2017;12(1):18-25
pubmed: 28322168
Pediatrics. 2012 Nov;130(5):e1269-77
pubmed: 23027172
Paediatr Drugs. 2010 Apr 1;12(2):99-103
pubmed: 20218746
Clin Pharmacokinet. 2015 Dec;54(12):1273-85
pubmed: 26063050
Arch Dis Child. 2010 Jun;95(6):469-73
pubmed: 20501540
BMJ. 2000 Jan 8;320(7227):79-82
pubmed: 10625257
JAMA. 2012 Oct 10;308(14):1435-6
pubmed: 23047355
Ital J Pediatr. 2010 Jan 15;36:4
pubmed: 20180963
Clin Pharmacokinet. 2014 Nov;53(11):1005-18
pubmed: 25154507
Br J Clin Pharmacol. 2018 Aug;84(8):1748-1756
pubmed: 29637588
Adv Drug Deliv Rev. 2014 Jun;73:2-13
pubmed: 24556465