中国临床药理学与治疗学2011，Vol.16Issue(5)：517-522,6.
单组临床试验目标值法的精确样本含量估计及统计推断
Exact method of sample size calculation and statistical inference in single-arm clinical trials with objective performance criteria
摘要
Abstract
AIM: To explore the exact method of sample size estimation and statistical inference in single-arm clinical trials with Objective Performance Criteria (OPC) based on binomial distribution principle.METHODS: This article will systematically and comprehensively discuss the exact method of sample size calculation, confidence interval estimation and hypothesis testing which the single-arm clinical trial method involves in.RESULTS:With the starting point of OPC at 75％ by an interval of 1％ increasing and the starting point of expected event rate at 76％ by an interval of 1％ increasing, corresponding exact sample sizes are calculated.And two sets of results under the condition of β of 0.20 and αof 0.05 (one sided and two sided) are tabulated respectively.The exact calculating formulas of confidence interval estimation and hypothesis testing are provided.CONCLUSION: Systematic methodology support is provided for OPC method in single-arm clinical trials in calculating sample size, estimating confidence interval and hypothesis testing.关键词
单组临床试验/目标值/精确法/样本含量/可信区间/假设检验Key words
Single-arm clinical trial/ Objective Performance Criteria/ Exact method/ Sample size/ Confidence interval/ Hypothesis testing分类
医药卫生引用本文复制引用
成琪,刘玉秀,陈林,刘丽霞..单组临床试验目标值法的精确样本含量估计及统计推断[J].中国临床药理学与治疗学,2011,16(5):517-522,6.基金项目
江苏省"六大人才高峰"第三批资助项目(06-C-031) （06-C-031）
