[关键词]
[摘要]
参考国内外儿童中药新药临床试验的相关法规与文献,并结合笔者的实践经验,对儿童中药新药Ⅳ期临床试验在试验目的、总体设计、诊断标准选择、病例纳排标准、给药方案、有效性评价、不良反应观察、试验流程、统计分析及伦理学要求等方面应注意的事项提出了自己的看法,以期为儿童用药Ⅳ期临床试验及上市后再评价研究设计提供借鉴。
[Key word]
[Abstract]
The author points out some special concerns on the designing, test purpose, diagnostic criteria for choosing, cases of inclusion, and exclusion criteria, dosage regimen, effectiveness evaluation, observation of adverse reactions, trial continuation process, statistical analysis, and ethics requirements in phase Ⅳ clinical trails of new drugs in Chinese materia medica for children, based on the relevant laws and regulations, literature reviews, and author's practical experience, so as to provide evidence for the phase IV clinical trials and postmarketing re-evaluation of children's drugs.
[中图分类号]
[基金项目]
“十二五”重大新药创制项目“儿科中药新药临床评价研究技术平台规范化建设”课题(2011ZX09302)