| 摘要: |
| [摘要]儿童药物开发滞后的一个重要原因是儿童药物临床试验开展困难。本文从知情同意和操作实施两个方面对儿童药物临床试验的困境做系统分析，并跳出儿童药物临床试验本身，从研究数据外推和上市后综合评价两个方面来探讨对策。 |
| 关键词: 儿童药物 临床试验 数据外推 上市后综合评价 |
| DOI：doi:10.13407/j.cnki.jpp.1672-108X.2020.05.010 |
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| 基金项目: |
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| Dilemma and Countermeasures of Children’s Clinical Trials in China |
| Zheng Hang1, Yuan Yonghua |
| (Pharmacy College of Chongqing Medical University, Chongqing 400016, China) |
| Abstract: |
| [Abstract] An essential reason for the delay in drug development for children is the difficulty in conducting clinical trials in children. This thesis systematically analyzes the dilemma of children’s clinical trials from informed consent and operation implementation, and discusses the countermeasures from two aspects of extrapolation of research data and comprehensive post-market evaluation besides children’s drug clinical trials. |
| Key words: drugs children clinical trials data extrapolation post-market evaluation |
