A new adaptive design based on Simon's two-stage optimal design for phase II clinical trials.
A new adaptive design based on Simon's two-stage optimal design for phase II clinical trials.
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基于西蒙 II 期临床试验两阶段优化设计的新自适应设计。
DOI：
10.1016/j.cct.2012.07.003
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发表时间：
2012
影响因子：
2.2
通讯作者：
Zhen Wei
中科院分区：
文献类型：
--
作者：
H. Jin;Zhen Wei
进行 II 期临床试验是为了确定新药剂或药物疗法是否有足够的前景治疗癌症，值得在更大的患者群体中进行进一步测试。如果早期结果明确表明新疗法不活跃或不值得进一步研究，则伦理和实际考虑通常需要提前终止 II 期试验。 Simon 的两阶段设计（1989）是进行研究新癌症疗法的 II 期研究的常用方法。 Banerjee 和 Tsiatis (2006) 提出了一种自适应两阶段设计，允许第二阶段的样本大小取决于第一阶段的结果。他们的设计比西蒙的更灵活，但有些违反直觉：随着第一阶段响应的增加，第二阶段样本量增加到某个点，然后突然变为零。在本文中，基于Simon的两阶段优化设计，我们提出了一种新的自适应设计，该设计依赖于第一阶段的结果，使用条件I类误差和条件功效的限制条件。对 Banerjee 和 Tsiatis 的结果与我们新的自适应设计进行了比较。
Phase II clinical trials are conducted to determine whether a new agent or drug regimen has sufficient promise in treating cancer to merit further testing in larger groups of patients. Both ethical and practical considerations often require early termination of phase II trials if early results clearly indicate that the new regimen is not active or worthy of further investigation. Simon's two-stage designs (1989) are common methods for conducting phase II studies investigating new cancer therapies. Banerjee and Tsiatis (2006) proposed an adaptive two-stage design which allows the sample size at the second stage to depend on the results at the first stage. Their design is more flexible than Simon's, but it is somewhat counter-intuitive: as the response in the first stage increases, the second-stage sample size increases till a certain point and then abruptly becomes zero. In this paper, based on Simon's two-stage optimal design, we propose a new adaptive one which depends on the first stage results using the restrict conditions the conditional type I error and the conditional power. Comparisons are made between Banerjee and Tsiatis' results and our new adaptive designs.
根据条件功效提前停止接受 H(o)：近似和比较。
影响因子：
1.9
作者：
Betensky,RA
通讯作者：
Betensky,RA