Impact of Different Regulatory Requirements for Trial Endpoints in Multiregional Clinical Trials

被引：0

作者：

Cynthia J. Girman

Ekopimo Ibia

Shailendra Menjoge

Carmen Mak

Joshua Chen

Anupam Agarwal

Bruce Binkowitz

机构：

[1] Merck Sharp and Dohme Corp,Dept. of Epidemiology

[2] Merck Sharp and Dohme Corp,undefined

[3] Boehringer-Ingelheim,undefined

[4] Merck Sharp and Dohme Corp,undefined

[5] Pfizer,undefined

[6] Merck Research Laboratories,undefined

来源：

Drug information journal : DIJ / Drug Information Association | 2011年 / 45卷

关键词：

Multiregional clinical trial; Endpoint; Hypothesis testing;

D O I：

暂无

中图分类号：

学科分类号：

摘要：

Regulatory agencies in different parts of the world may have different requirements for end-points, which significantly affects the design and conduct of registrational multiregional clinical trials (MRCT). In particular, different health authorities may request or require different endpoints as primary or key secondary hypotheses in phase 3 MRCTs. In addition, differences between regions may involve the time point considered primary, patient populations analyzed, study design, or noninferiority margins.

引用

页码：587 / 594

页数：7

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