Adaptive designs in clinical drug development - An Executive Summary of the PhRMA Working Group
Adaptive designs in clinical drug development - An Executive Summary of the PhRMA Working Group
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DOI：
10.1080/10543400600614742
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发表时间：
2006-05-01
影响因子：
1.1
通讯作者：
Pinheiro, Jose
中科院分区：
文献类型：
--
作者：
Gallo, Paul;Chuang-Stein, Christy;Pinheiro, Jose
已经成立了一个关于适应性临床试验设计的PhRMA工作组，以调查和促进适应性设计和相关方法的更广泛接受和使用的机会。一份总结该小组调查结果的白色文件正在编写中;本文是该完整白色文件的执行摘要，并总结了该小组的调查结果和建议。与适应性设计相关的物流，操作，程序和统计挑战得到解决。三个特定的领域，它认为，自适应设计可以利用有益的讨论：剂量发现，无缝II/III期试验设计，和样本量重新估计。
A PhRMA Working Group on adaptive clinical trial designs has been formed to investigate and facilitate opportunities for wider acceptance and usage of adaptive designs and related methodologies. A White Paper summarizing the findings of the group is in preparation; this article is an Executive Summary for that full White Paper, and summarizes the findings and recommendations of the group. Logistic, operational, procedural, and statistical challenges associated with adaptive designs are addressed. Three particular areas where it is felt that adaptive designs can be utilized beneficially are discussed: dose finding, seamless Phase II/III trials designs, and sample size reestimation.