Statistical Implications of Extrapolating the Overall Result to the Target Region in Multi-Regional

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

【摘要】

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【作者】

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SEUNG-HO KANG SAEMINA KIM

【机构】

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Department of Applied Statistics,Yonsei University,Korea

【出处】

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上海交通大学

【发表日期】

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2016年4期

【关键词】

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consistency type Ⅰ error rate power intrinsic factor extrinsic factor

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　　The one of principles described in ICH E9 is that only results obtained from pre-specified statistical methods in protocol is regarded as confirmatory evidences.However,in multi-regional clinical trials,although results obtained from pre-specified statistical methods in protocol is significant,it does not guarantee that the test treatment is approved by regional regulatory agencies.

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Statistical Implications of Extrapolating the Overall Result to the Target Region in Multi-Regional

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