Blinded sample size adjustment

作     者：Bristol, DR Shurzinske, L 

作者机构：Purdue Pharma LP Biostat & Stat Programming Stamford CT 06901 USA Pfizer Global Res & Dev Biostat Ann Arbor MI USA 

出 版 物：《DRUG INFORMATION JOURNAL》 (药物信息杂志)

年 卷 期：2001年第35卷第4期

页      面：1123-1130页

核心收录：

学科分类：1007[医学-药学(可授医学、理学学位)] 12[管理学] 1204[管理学-公共管理] 120402[管理学-社会医学与卫生事业管理(可授管理学、医学学位)] 1004[医学-公共卫生与预防医学(可授医学、理学学位)] 10[医学] 

主　　题：sample size blinding two-stage 

摘      要：The determination of the appropriate sample size is an important aspect of planning a clinical trial. In recent years, procedures for estimation of a nuisance parameter to adjust the sample size if necessary have been examined. Here, it is assumed that the clinical trial is conducted for the comparison, of two treatments, where the observations are assumed to have normal distributions with a common unknown variance. For sample size determination, the variance is assumed known and the resulting sample size is sensitive to misspecification of the variance. An estimate of the variance, obtained while the clinical trial is ongoing, can often be used to assess the appropriateness of the assumed variance. The use of a blinded estimate of the variance to potentially adjust the sample size is examined.