Sylvester R
Eortc Data Center, Brussels, Belgium.
Acta Urol Belg. 1994 Apr;62(1):23-9.
This paper presents an overview of various statistical concepts related to the design and analysis of prostate cancer trials: the need for randomization, stratification for prognostic factors, sample size determination, trial objectives, the choice of a control group, patient entry criteria, the number of treatments to be compared, the choice of endpoints, analysis by the intent to treat principle, interim statistical analysis and early stopping rule, and subgroup analyses.
随机化的必要性、预后因素的分层、样本量的确定、试验目的、对照组的选择、患者入选标准、待比较的治疗方法数量、终点的选择、按意向性分析原则进行分析、期中统计分析和提前终止规则,以及亚组分析。