Statistical Notes. Randomized controlled clinical trials of superiority and non-inferiority: critical considerations

被引：0
|
作者：
Marubini, Ettore [1 ]
Rebora, Paola [1 ]
Reina, Giuseppe [1 ]
机构：
[1] Univ Milan, Ist Stat Med & Biometria, Via Venezian 1, I-20133 Milan, Italy
来源：
GIORNALE ITALIANO DI CARDIOLOGIA | 2005年 / 6卷 / 06期
关键词：
Analysis per protocol; Intention-to-treat; Non-inferiority randomized controlled clinical trials; Superiority randomized controlled clinical trials;
D O I：
暂无
中图分类号：
R5 [内科学];
学科分类号：
1002 ; 100201 ;
摘要：
The aim of this statistical note, the fourth in the series, is to describe and critically appraise the randomized controlled clinical trial (RCCT) GUSTO V, which combined in a single RCCT both the superiority and non-inferiority hypotheses. In this note we present the logical path that the authors have presumably followed in planning a RCCT of such a kind. The results are reported and possible critical aspects are highlighted and debated upon. Finally the cardiologist reader is stimulated to give his own opinion on this kind of approach.
引用
收藏
页码：361 / 364
页数：4
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