Seamless phase II/III designs
Seamless phase II/III designs
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DOI：
10.1177/0962280210379035
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发表时间：
2011-12-01
影响因子：
2.3
通讯作者：
Todd, Susan
中科院分区：
文献类型：
--
作者：
Stallard, Nigel;Todd, Susan
近年来，人们一直在努力节省开发成本，缩短新疗法的上市时间。为了实现这一目标，对新型试验设计的研究导致了无缝II/III期设计方法的开发。这种设计允许在中期分析时选择治疗或剂量，并在同一研究中与对照组进行疗效比较评价。方法已经获得了广泛的关注，因为它们的潜在优势相比，传统的药物开发计划与单独的试验，为个别阶段。在这篇文章中，我们回顾了基于组序贯方法，组合检验方法和自适应Dunnett方法的无缝II/III期设计的各种方法。本文的目的是在一个统一的框架内描述这些方法，并强调它们的相似性和差异，以便考虑进行此类试验的试验者选择适当的方法。
In recent years, there has been a drive to save development costs and shorten time-to-market of new therapies. Research into novel trial designs to facilitate this goal has led to, amongst other approaches, the development of methodology for seamless phase II/III designs. Such designs allow treatment or dose selection at an interim analysis and comparative evaluation of efficacy with control, in the same study. Methods have gained much attention because of their potential advantages compared to conventional drug development programmes with separate trials for individual phases. In this article, we review the various approaches to seamless phase II/III designs based upon the group-sequential approach, the combination test approach and the adaptive Dunnett method. The objective of this article is to describe the approaches in a unified framework and highlight their similarities and differences to allow choice of an appropriate methodology by a trialist considering conducting such a trial.