摘要
Ⅱ期临床试验的主要目的是对药物治疗的安全性和有效性进行评估.针对具有高安全性的Ⅱ期两阶段临床试验,给出小样本量下关于安全性和有效性的精确检验方法,并证明最大Ⅰ类错误概率与Ⅱ类错误概率分别在原假设和备择假设的边界处达到.在期望样本量最小原则下,给出最优两阶段设计的构造方法和常用设计表,供实际应用选用.
The main purpose of phase II clinical trials is to assess both the effectiveness and safety of a treatment.In this paper,we focus on the two-stage clinical trials of high safety and derive exact tests to establish both effectiveness and safety based on small samples.We show that the maximums of the type I and Ⅱ error rates are achieved at the boundaries of hypothesis spaces.Also,we construct optimal two-stage clinical trials with the least expected total sample size and provide a table of these clinical trials for practice.
作者
杨贵军
杨景博
杨雪
王维真
YANG Guijun;YANG Jingbo;YANG Xue;WANG Weizhen(School of Statistics,Tianjin University of Finance and Economics,Tianjin 300222;Department of Mathematics and Statistics,Wright State University,OH 45435)
出处
《系统科学与数学》
CSCD
北大核心
2020年第2期318-326,共9页
Journal of Systems Science and Mathematical Sciences
基金
国家自然科学基金项目面上项目(11471239)
国家自然科学基金青年项目(11601366)资助课题。
