SOME CONSIDERATIONS ON HOW TO PARTICIPATE MRCT IN CHINA

来源 :上海交通大学 | 被引量 : 0次 | 上传用户：catherine00800

【摘要】

：

【作者】

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Yingxue Cathy Liu Sharon Pan Zhen Luo

【机构】

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Pfizer Inc.,201203,China Pfizer Inc.,10017,Unites

【出处】

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上海交通大学

【发表日期】

：

2016年4期

【关键词】

：

MRCT ICH E17 China IMCT guideline sample size enrollment

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论文部分内容阅读

　　This talk focuses on the implementation of participating MRCT in China.The key points of ICH E17 and China IMCT guideline will be reviewed; the sample size of Chinese patients in MRCT will be calculated based on normal distribution for two different requirements in both superiority and non-inferiority clinical trials.Potential solution of enrollment issues will be discussed.

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SOME CONSIDERATIONS ON HOW TO PARTICIPATE MRCT IN CHINA

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