Analysis on the current situation of pediatric drug clinical trials in China
10.3760/cma.j.cn111325-20230425-00329
- VernacularTitle:我国儿科药物临床试验开展现状分析
- Author:
Wenxiang FAN
1
;
Tongtong LAI
;
Rui WANG
;
Chunmei LI
;
Shaoqing NI
Author Information
1. 浙江大学医学院附属儿童医院临床试验机构管理办公室 国家儿童健康与疾病临床医学研究中心，杭州 310052
- Keywords:
Pediatric;
Clinical trials of drugs;
Registration of drug clinical trial institutions;
Registration of clinical trials for new drugs;
Situation analysis
- From:
Chinese Journal of Hospital Administration
2023;39(12):945-951
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To understand the current situation and problems of pediatric drug clinical trials in China, and provide reference for the healthy development of pediatric drug clinical trials.Methods:Such keywords as " pediatrics" " children" " annual reports" " children′s drug research and development" " policies" were used, to search for information on China′s pediatric drug research and development policies and regulations, pediatric drug clinical trial institutions and pediatric drug clinical trial professional registration status, as well as pediatric drug clinical trial project registration status as of October 2023 on the drug clinical trial institution registration management information platforms and relevant government department websites. Then descriptive analysis was made on the collected information.Results:China has released 9 policies and regulations on pediatric drug research and development, supporting the development of new varieties, dosage forms, and specifications of pediatric drugs that meet the physiological characteristics of children, and giving priority review and approval to pediatric drugs. 477 drug technology guiding principles have been released, but only 14 of them were specifically designed for pediatric populations. As of March 20, 2023, there were a total of 272 registered pediatric drug clinical trial institutions, accounting for 20.72% of the total number of registered institutions. The top 5 provinces for their number of registered institutions were Guangdong province (34), Henan province (21), Zhejiang province (20), Beijing (20), and Jiangsu province (18); A total of 26 clinical trial specialties for pediatric drugs have been registered, with the largest number of registrations being pediatric respiratory (143), pediatric hematology (72), pediatrics other (71), pediatric endocrinology (68), and pediatric neurology (64). From 2020 to 2022, the proportion of pediatric drug clinical trial registration projects in newly registered drug clinical trials was 8.8% (129/1 473), 8.3% (168/2 033), and 8.3% (164/1 974), respectively, while clinical trials conducted only in the pediatric population accounted for 2.2% (33/1 473), 3.0% (61/2 033), and 3.2% (64/1 974), respectively.Conclusions:The policies and regulations on pediatric drug research and development in China still need further improvement. The number of registered pediatric drug clinical trial institutions and pediatric specialties is lower than that of adults and distributed unevenly. Clinical trial registration projects for pediatric drugs, especially those conducted in the pediatric population, account for a relatively small proportion. It is recommended to further improve the policy system for drug research and development in the pediatric population, optimize the layout of pediatric drug clinical trial institutions and specialties in the country.
