Dose selection in seamless phase II/III clinical trials based on efficacy and safety
Dose selection in seamless phase II/III clinical trials based on efficacy and safety
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DOI：
10.1002/sim.3522
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发表时间：
2009-03-15
影响因子：
2
通讯作者：
Hutton, Jane L.
中科院分区：
文献类型：
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作者：
Kimani, Peter K.;Stallard, Nigel;Hutton, Jane L.
无缝II/III期临床试验在新药开发中很有吸引力，因为它们加速了药物开发过程。无缝II/III期试验分两个阶段进行。第一阶段（第二阶段）后，进行中期分析并决定是否进入第二阶段（第三阶段）。如果决定继续进一步测试，则使用一些剂量选择程序来确定第 2 阶段要测试的剂量组。在本文中，我们提出了一种针对适应性无缝 II/III 期临床试验中二元结果的剂量选择程序，该程序结合了实验治疗是同一药物的不同剂量水平时的剂量-反应关系，并明确结合了疗效和安全性。通过比较可能继续的潜在剂量组的预测能力来选择继续到第 2 阶段的剂量。版权所有 (C) 2009 John Wiley & Sons, Ltd.
Seamless phase II/III clinical trials are attractive in development of new drugs because they accelerate the drug development process. Seamless phase II/III trials are carried out in two stages. After stage I (phase II stage), an interim analysis is performed and a decision is made on whether to proceed to stage 2 (phase III stage). If the decision is to continue with further testing, some dose-selection procedure is used to determine the set of doses to be tested in stage 2. In this paper, we propose a dose-selection procedure for binary outcomes in adaptive seamless phase II/III clinical trials that incorporates the dose-response relationship when the experimental treatments are different dose levels of the same drug, and explicitly incorporates both efficacy and safety. The choice of the doses to continue to stage 2 is made by comparing the predictive power of the potential sets of doses, which might continue. Copyright (C) 2009 John Wiley & Sons, Ltd.