The rapid enrollment design for Phase I clinical trials

作者：Anastasia Ivanova, Yunfei Wang, Matthew C. Foster · 发表于：Statistics in Medicine · 年份：2016 · DOI：10.1002/sim.6886 · 被引用次数：20 · 研究领域：Statistical Methods in Clinical Trials、Health Systems, Economic Evaluations, Quality of Life、Meta-analysis and systematic reviews

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.