Statistical strategies for the analysis of clinical trials with an experimental treatment, an active control and placebo, and a prespecified fixed non-inferiority margin for the difference in means

被引：7
作者：
Roehmel, Joachim [1 ]
Pigeot, Iris [1 ]
机构：
[1] Univ Bremen, Bremen Inst Prevent Res & Social Med, D-28359 Bremen, Germany
来源：
STATISTICS IN MEDICINE | 2011年 / 30卷 / 26期
关键词：
GOLD STANDARD DESIGN; ESTABLISHING EFFICACY;
D O I：
10.1002/sim.4299
中图分类号：
Q [生物科学];
学科分类号：
07 ; 0710 ; 09 ;
摘要：
引用
收藏
页码：3162 / 3164
页数：3
相关论文
共 13 条
[1]  
[Anonymous], 2011, ICH HARM TRIP GUID S
[2]   Rejoinder to "Establishing efficacy of a new experimental treatment in the 'gold standard' design" [J].
Hauschke, D ;
Pigeot, I .
BIOMETRICAL JOURNAL, 2005, 47 (06) :797-798
[3]  
Hauschke D, 2005, BIOMETRICAL J, V47, P782, DOI 10.1002/bimj.200510169
[4]   On the three-arm non-inferiority trial including a placebo with a prespecified margin [J].
Hida, Eisuke ;
Tango, Toshiro .
STATISTICS IN MEDICINE, 2011, 30 (03) :224-231
[5]  
Hung HMJ, 2005, BIOMETRICAL J, V47, P795, DOI 10.1002/bimj.200510180
[6]  
ICH, 2011, ICH HARM TRIP GUID C
[7]   Discussion on "Establishing efficacy of a new experimental treatment in the 'gold standard' design" [J].
Koch, A .
BIOMETRICAL JOURNAL, 2005, 47 (06) :792-793
[8]  
Koch Armin, 2004, J Biopharm Stat, V14, P315
[9]  
Lewis JA, 2005, BIOMETRICAL J, V47, P787, DOI 10.1002/bimj.200510182
[10]   A group sequential type design for three-arm non-inferiority trials with binary endpoints [J].
Li, Gang ;
Gao, Shan .
BIOMETRICAL JOURNAL, 2010, 52 (04) :504-518
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