I期临床试验的快速入组设计。
The rapid enrollment design for Phase I clinical trials.
作者信息
Ivanova Anastasia, Wang Yunfei, Foster Matthew C
机构信息
Department of Biostatistics, University of North Carolina at Chapel Hill, Chapel Hill, NC, 27599-7420, U.S.A.
Departments of Pediatrics and Biostatistics, George Washington University and Children's National Medical Center, Washington DC, 20010, U.S.A.
出版信息
Stat Med. 2016 Jul 10;35(15):2516-24. doi: 10.1002/sim.6886. Epub 2016 Feb 1.
Abstract
We propose a dose-finding design for Phase I oncology trials where each new patient is assigned to the dose most likely to be the target dose given observed data. The main model assumption is that the dose-toxicity curve is non-decreasing. This method is beneficial when it is desirable to assign a patient to a dose as soon as the patient is enrolled into a study. To prevent assignments to doses with limited toxicity information in fast accruing trials we propose a conservative rule that assigns temporary fractional toxicities to patients still in follow-up. We also recommend always using a safety rule in any fast accruing dose-finding trial. Copyright © 2016 John Wiley & Sons, Ltd.
摘要
我们提出了一种用于I期肿瘤试验的剂量探索设计，在该设计中，根据观察到的数据，将每位新患者分配到最有可能是目标剂量的剂量组。主要的模型假设是剂量-毒性曲线是非递减的。当希望在患者一纳入研究就将其分配到某个剂量组时，这种方法是有益的。为了防止在快速入组试验中把患者分配到毒性信息有限的剂量组，我们提出了一条保守规则，即给仍在随访中的患者分配临时的部分毒性值。我们还建议在任何快速入组的剂量探索试验中始终使用安全规则。版权所有© 2016约翰·威利父子有限公司。
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