Improved BOIN12 Design based on Conditional Weighted Likelihood Method
10.11783/j.issn.1002-3674.2024.01.002
- VernacularTitle:基于条件加权似然方法的BOIN12设计的改进研究
- Author:
Tian XIA
1
;
Yucheng ZHANG
;
Wenyun YANG
Author Information
1. 中国药科大学生物统计与计算药学研究中心(210009)
- Keywords:
Conditional weighted likelihood;
Phase Ⅰ-Ⅱ design;
BOIN12 design;
Delayed effect
- From:
Chinese Journal of Health Statistics
2024;41(1):7-11,17
- CountryChina
- Language:Chinese
-
Abstract:
Objective The BOIN12 design was improved based on conditional weighted likelihood method to solve the optimal dose exploration in the case of delayed toxicity and efficacy of drugs.Methods The conditional weighted likelihood method was used to estimate the toxicity rate and conditional efficacy rate.The improved BOIN12 design was compared with other phase Ⅰ-Ⅱ design through simulation to evaluate its performance.Results Simulation results show that the improved design still has excellent statistical performance in different scenarios and the trial duration is greatly shortened.Conclusion The improved design can addresses both toxicity and efficacy delays in phase Ⅰ-Ⅱ trials.
