I期试验中用于评估多种类型和等级毒性的总i3+3 (Ti3+3)设计

Meizi Liu, Yuan Ji, Ji Lin
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引用次数: 0

摘要

I期试验研究一种新疗法的毒性特征,并确定最大耐受剂量,以供进一步评估。大多数I期试验使用二元剂量限制毒性终点来总结剂量的毒性概况。实际上,报告的毒性信息要丰富得多,包括各种类型和等级的不良事件。在i3+3设计的基础上(Liu et al., 2020),我们提出了Ti3+3设计,其中字母“T”代表“总”毒性。所建议的设计通过计算每次剂量下的毒性负担来考虑多种毒性类型和等级。Ti3+3设计旨在通过使用“毒性负荷区间”(TBI)的简单统计框架来实现理想的操作特性。仿真结果表明,Ti3+3具有与现有更复杂设计相当的性能。
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The Total i3+3 (Ti3+3) Design for Assessing Multiple Types and Grades of Toxicity in Phase I Trials
Phase I trials investigate the toxicity profile of a new treatment and identify the maximum tolerated dose for further evaluation. Most phase I trials use a binary dose-limiting toxicity endpoint to summarize the toxicity profile of a dose. In reality, reported toxicity information is much more abundant, including various types and grades of adverse events. Building upon the i3+3 design (Liu et al., 2020), we propose the Ti3+3 design, in which the letter “T” represents “total” toxicity. The proposed design takes into account multiple toxicity types and grades by computing the toxicity burden at each dose. The Ti3+3 design aims to achieve desirable operating characteristics using a simple statistics framework that utilizes“toxicity burden interval” (TBI). Simulation results show that Ti3+3 demonstrates comparable performance with existing more complex designs.
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