摘要
目的通过对比《ICH Harmonised Tripartite Guideline Statistical Principles Clinical Trails E9》与《化学药物和生物制品临床试验的生物统计学技术指导原则》的差别,为后者的修订提供参考。方法以ICH E9为基础,逐个条目对比两指导原则差别,并分析对国内指导原则的修改方向及必要性。结果两指导原则在总体上对于临床试验中的统计学问题处理意见相同,在细节上,ICH E9中描述的内容更为全面和具体,国内指导原则应有所借鉴。结论国内指导原则的修订中,可考虑参照ICH E9充实内容,从而提高其对实际操作的指导意义;充分强调在方案制订过程中对统计学问题的考虑;增加独立数据监查委员会、动态随机化等内容,促进国内临床试验水平与国际接轨。
Objective Through finding differences between ＂ICH Harmonised Tripartite Guideline, Statistical Principles Clinical Trails E9＂ and ＂Chinese Guideline of Statistical Principles in Clinical Trials＂, we aimed to provide references to the revised edition of Chinese guideline. Methods ICH E9 based comparison was done to analyze the necessity and directions of the amendment. Results Two guidelines gave same suggestions on principles in clinical trials in general, But in detail ,contents in ICH E9 were more comprehensive and specific. Conclusion It was necessary to add more details to Chinese guidelinewhich could be meaning- ful to the conduction of clinical trials. Statistical problems should be consid- ered when protocols were designed. And it would promote the level of Chi- nese trails if contents such as IDMC and dynamic randomization were added to the amendment.
出处
《中国卫生统计》
CSCD
北大核心
2012年第4期529-534,共6页
Chinese Journal of Health Statistics
关键词
临床试验
生物统计学指导原则
ICH
E9
Clinical Trails
Chinese Guideline of Statisti- cal Principles in Clinical Trials
ICH E9
