抗肿瘤药Ⅰ期临床试验贝叶斯最优区间设计方法及其与3+3设计的比较

Bayesian optimal interval design method for phase Ⅰ clinical trials of antineoplastic drugs and its comparison with 3 + 3 design

目前我国抗肿瘤药I期临床试验仍在延用3+3设计,应用更为准确安全的新方法改进I期临床试验效果十分必要。本文旨在介绍国外贝叶斯最优区间设计(BOIN)应用方法的基础上,以某抗肿瘤药Ⅰ期临床试验为例,通过和传统3+3设计的比较,详细说明了BOIN设计方法的实施流程。结果显示,在设计原理、操作特性、目标毒性率定义、最大耐受剂量(MTD)确定方面BOIN设计优于3+3设计;在易用性上,2种方法相似。

At present,the 3+3 design is still applied in phaseⅠclinical trials of antineoplastic drugs in China,and it is necessary to improve the efficacy of phase I clinical trials by applying new and more accurate and safe methods.Based on the introduction of the Bayesian optimal interval design(BOIN)method,this paper illustrated the implementation process of the BOIN design method by comparing it with the traditional 3+3 design of an antineoplastic drug.The results showed that the BOIN design was superior to the 3+3 design in terms of design principle,operational characteristics,target toxicity probability definition and MTD determination.The two approaches are similar in terms of ease of use.