Development of drug clinical trials in short stature children in China
10.13699/j.cnki.1001-6821.2024.16.022
- VernacularTitle:我国矮身材儿童药物临床试验的开展状况
- Author:
Guan-Dong ZHANG
1
;
Yu YANG
;
Rui-Ling ZHAO
Author Information
1. 山西省儿童医院药物临床试验机构办公室,山西太原 030013
- Keywords:
growth disorders;
slow-growing;
clinical trials;
marketed drug
- From:
The Chinese Journal of Clinical Pharmacology
2024;40(16):2405-2408
- CountryChina
- Language:Chinese
-
Abstract:
Objective To analyze the registration status of domestic drug clinical trials for short stature children and the marketing status of growth hormone drugs in China during 2013-2023.Methods The website of National Medical Products Administration was searched to abtain the date and statistical analysis was conducted.Results A total of 31 drug clinical trials involving short stature children were registered in the platform,and the trial stages were mainly on phase Ⅱ and Ⅲ,with a total of 21(67.74％,21/31).The group leader was relatively focused on specialized hospital,which was closely related to the academic level,clinical trial experience and professional authority of the main investigators.Based on the duration of treatment for short stature,83.87％(26/31)of registered projects had clinical trials lasting for more than 52 weeks.The research trend was long-acting growth hormone(64.52％,20/31).Sponsors and researchers had high insurance awareness and enthusiasm for clinical trials,especially the protection of subjects.At present,growth hormone products from seven domestic and foreign enterprises had been approved for marketing in China.The growth hormone products were the most abundant category of biotechnology drugs that had been marketed so far.Conclusion It is expected that there will be more convenient ways of administration and better release characteristics of long-acting growth hormone products in the future,which will reduce treatment costs and enable short stature children to obtain an ideal healthy height.
