An Adaptive Design for Phase II Non-Oncology Dose Selection Clinical Trials

被引：0
作者：
Zheng Su
机构：
[1] Genentech Inc.,
来源：
Clinical Drug Investigation | 2010年 / 30卷
关键词：
Interim Analysis; Adaptive Design; Fixed Sample Size; True Response Rate; Response Rate Estimate;
D O I：
暂无
中图分类号：
学科分类号：
摘要：
Background: A non-oncology dose selection phase II trial tests multiple active doses in a controlled fashion, and it not only needs to determine whether the treatment is effective but also to select the ‘lowest efficacious’ dose if the treatment is indeed efficacious. Few approaches exist in the literature for designing phase II non-oncology dose selection trials, and the standard design with a fixed sample size has been widely used.
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页码：397 / 403
页数：6
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