| 摘要: |
| 目的:检索分析我国儿童药物临床试验的注册及开展情况,为我国儿童药品研发提供参考。 方法:检索 2013 年 9 月 6 日 至 2022 年 4 月 19 日药物临床试验登记与信息公示平台中以儿童为受试者的药物临床试验公示信息,对其试验状态、适应证、 首次公示日期、试验药物类型、申办者信息等进行统计分析。 结果:共检索到儿童药物临床试验登记项目 207 项,儿童药物临床 试验注册数量随时间推移总体呈上升趋势。 儿童药物临床试验多为国内试验,近十年来国际多中心项目占比较低(16. 9%)。 我国以江苏省申办的药物临床试验注册项目最多,牵头儿童药物临床试验项目最多的机构是首都医科大学附属北京儿童医院, 儿童药物临床试验的样本量多为 200~1 000 例(43. 5%)。 儿童呼吸系统疾病防治领域的药物临床试验项目最多。 结论:我国 儿童药物临床试验数量逐年增长,但国际多中心试验占比仍然较低。 儿童药物临床试验研究领域相对局限,主要集中在传统的 呼吸系统疾病防治领域。 |
| 关键词: 儿童药品 临床试验 注册 |
| DOI：10. 13407/ j. cnki. jpp. 1672-108X. 2023. 12. 001 |
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| 基金项目: |
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| Current Status of Registered Clinical Trials of Children’s Drugs in China |
| Ma Yanjiao1 , Wang Yueqi2 , Zheng Shixiang1 |
| (1. Zhujiang Hospital of Southern Medical University, Guangzhou 510280, China; 2. College of Pharmacy, Jinan University, Guangzhou 510632, China) |
| Abstract: |
| Objective: To retrieve and analyze the registration and development of clinical trials of children’s drugs in China, so as to provide reference for the research and development of children’s drugs. Methods: By retrieving publicly available information of clinical trials of children’ s drugs on the platform of registry and publicity of drug clinical trials from Sept. 6th , 2013 to Apr. 19th , 2022, statistical analysis was conducted on trial status, indications, initial disclosure dates, types of investigational drugs and sponsor information. Results: A total of 207 clinical trial registration projects of children’ s drugs were retrieved. The number of registered clinical trials of children’s drugs showed an overall increasing trend over time. Clinical trials of children’s drugs were mostly conducted domestically, with international multi-center projects accounting for a relatively low proportion over the past decade ( 16. 9%). In China, Jiangsu had the highest number of registered clinical trial projects by sponsors, and Beijing Children’s Hospital, Capital Medical University led the most clinical trials of children’ s drugs. The majority of clinical trials of children’ s drugs had sample sizes ranging from 200 to 1,000 participants (43. 5%). The field of clinical trials of children’s drugs had the highest number of projects in the area of pre-treatment for children’s respiratory system diseases. Conclusion: The number of clinical trials of children’s drugs in China has been increasing year by year, yet the proportion of international multi-center trials remains relatively low. The field of research in children’s drug clinical trials is relatively limited, which primarily focus on traditional treatments for respiratory system diseases in children. |
| Key words: children’s drugs clinical trials registration |
