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有序组中I期试验的设计。

Designs for phase I trials in ordered groups.

作者信息

Conaway Mark R, Wages Nolan A

机构信息

Division of Translational Research and Applied Statistics, Department of Public Health Sciences, The University of Virginia, 22908, CharlottesvilleVA, U.S.A.

出版信息

Stat Med. 2017 Jan 30;36(2):254-265. doi: 10.1002/sim.7133. Epub 2016 Sep 14.

DOI:10.1002/sim.7133
PMID:27624880
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5140690/
Abstract

We propose a new design for dose finding for cytotoxic agents in two ordered groups of patients. By ordered groups, we mean that prior to the study there is clinical information that would indicate that for a given dose one group would be more susceptible to toxicities than patients in the other group. The designs are evaluated relative to two previously proposed designs for ordered groups over a range of scenarios generated randomly from a family of dose-toxicity curves. Copyright © 2016 John Wiley & Sons, Ltd.

摘要

我们提出了一种针对两组有序患者群体中细胞毒性药物剂量探索的新设计。所谓有序群体,是指在研究之前存在临床信息表明,对于给定剂量,一组患者比另一组患者更容易出现毒性反应。在从一系列剂量-毒性曲线随机生成的一系列场景中,将这些设计与之前提出的两种针对有序群体的设计进行了评估比较。版权所有© 2016约翰·威利父子有限公司。

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Stat Med. 2017 Jul 10;36(15):2323-2332. doi: 10.1002/sim.7295. Epub 2017 Apr 6.
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Bridging Solutions in Dose Finding Problems.剂量探索问题中的桥接解决方案
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Phase I design for completely or partially ordered treatment schedules.完全或部分有序治疗方案的I期设计
Stat Med. 2014 Feb 20;33(4):569-79. doi: 10.1002/sim.5998. Epub 2013 Sep 30.
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Specifications of a continual reassessment method design for phase I trials of combined drugs.联合用药 I 期试验的连续重新评估法设计规范。
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A phase I study of sorafenib and vorinostat in patients with advanced solid tumors with expanded cohorts in renal cell carcinoma and non-small cell lung cancer.一项索拉非尼和伏立诺他治疗晚期实体瘤患者的 I 期研究,扩大了肾细胞癌和非小细胞肺癌队列。
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