Two-stage winner designs for non-inferiority trials with pre-specified non-inferiority margin

详细信息    查看全文

• 关键词：Non-inferiority trials ; Adaptive design ; Two-stage design
• 刊名：Journal of Statistical Planning and Inference
• 出版年：2017
• 出版时间：April 2017
• 年：2017
• 卷：183
• 期：Complete
• 页码：44-61
• 全文大小：1345 K
• 卷排序：183

文摘

Extended two-stage winner designs to non-inferiority trials. Provided rigorous justifications to determine the critical value. Studied sample size and power calculations for the design. Using the exact distribution of the test statistics as well as normal approximations. Theoretical justifications and extensive numerical assessments were conducted.