在I期肿瘤临床试验中对毒性数据采取审慎的方法。
Taking a Measured Approach to Toxicity Data in Phase I Oncology Clinical Trials.
作者信息
Sharma Manish R, Ratain Mark J
机构信息
Department of Medicine and Committee on Clinical Pharmacology and Pharmacogenomics, University of Chicago, Chicago, Illinois.
出版信息
Clin Cancer Res. 2016 Feb 1;22(3):527-9. doi: 10.1158/1078-0432.CCR-15-2005. Epub 2015 Oct 14.
Abstract
The standard categorical system for assessing attribution of toxicity to study drug(s) in phase I trials is cumbersome and uninformative. Although a binary system ("related" vs. "unrelated") would be sufficient to define maximum tolerated dose (MTD), a probability estimation would better support dose selection for randomized dose-ranging phase II trials.
摘要
用于评估I期试验中研究药物毒性归因的标准分类系统既繁琐又缺乏信息量。虽然二元系统（“相关”与“不相关”）足以定义最大耐受剂量（MTD），但概率估计将更有助于支持随机剂量范围II期试验的剂量选择。
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