Superiority, equivalence or non-inferiority?

被引:9
作者
Cipriani, Andrea [1 ]
Girlanda, Francesca [1 ]
Barbui, Corrado [1 ]
机构
[1] Univ Verona, Dept Med & Publ Hlth, Sect Psychiat & Clin Psychol, I-37134 Verona, Italy
来源
EPIDEMIOLOGIA E PSICHIATRIA SOCIALE-AN INTERNATIONAL JOURNAL FOR EPIDEMIOLOGY AND PSYCHIATRIC SCIENCES | 2009年 / 18卷 / 04期
关键词
superiority; non-inferiority; randomised controlled trial; statistics; equivalence studies; CLINICAL-TRIALS;
D O I
10.1017/S1121189X00000269
中图分类号
R749 [精神病学];
学科分类号
100205 ;
摘要
One of the most important critical decision to be taken when designing a randomized controlled trial (RCT) in clinical psychopharmacology is the choice of the comparator. This choice is crucial because it affects many issues related to both internal and external validity. The aim of a RCT may be to establish efficacy in absolute terms, against an inert treatment (usually a placebo), or to establish efficacy with respect to another treatment (also known as comparator), a trial may be designed to demonstrate that the new drug is superior to the control intervention or, by contrast, that the new drug is similar to the control intervention in terms of, say, symptoms' reduction. Three kinds of RCTs may be designed: Superiority trials, Equivalence studies, Non-inferiority studies.
引用
收藏
页码:311 / 313
页数:3
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