Adaptive seamless phase II/III designs - Background, operational aspects, and examples
Adaptive seamless phase II/III designs - Background, operational aspects, and examples
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DOI：
10.1177/216847900604000412
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发表时间：
2006-01-01
影响因子：
--
通讯作者：
Krams, Michael
中科院分区：
文献类型：
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作者：
Maca, Jeff;Bhattacharya, Suman;Krams, Michael
适应性无缝设计被认为是缩短发现、开发和证明新药益处所需的时间和患者暴露的一种可能方法。我们介绍了自适应设计的概念，并描述了目前的统计方法，自适应无缝设计。我们还描述了无缝设计所涉及的决策过程，并提出了一些说明性的例子。
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.