Adaptive seamless phase II/III designs - Background, operational aspects, and examples

被引：83

作者：

Maca, Jeff

Bhattacharya, Suman

Dragalin, Vladimir

Gallo, Paul

Krams, Michael

机构：

[1] Novartis Pharmaceut, E Hanover, NJ 07936 USA

[2] Genentech Inc, San Francisco, CA 94080 USA

来源：

DRUG INFORMATION JOURNAL | 2006年 / 40卷 / 04期

关键词：

adaptive designs; seamless designs;

D O I：

10.1177/216847900604000412

中图分类号：

R19 [保健组织与事业（卫生事业管理）];

学科分类号：

摘要：

Adaptive seamless designs have been considered as one possible way to shorten the time and patient exposure necessary to discover, develop, and demonstrate the benefits of a new drug. We introduce the concept of adaptive designs and describe the current statistical methodologies that relate to adaptive seamless designs. We also describe the decision process involved with seamless designs and present some illustrative examples.

引用

页码：463 / 473

页数：11

共 29 条

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2-V

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