[Statlist] Séminaires de Statistique - Institut de Statistique, Université de Neuchâtel

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S�minaires de Statistique 
Institut de Statistique, Universit� de Neuch�tel 

Pierre � Mazel 7 (1er �tage,salle 110), Neuch�tel,

http://www2.unine.ch/statistics



Mardi 13 Mars 2007, 11h00

Valentin Rousson, Biostatistics Unit, University of Zurich, SWITZERLAND

 

Title : A mixed approach for proving non-inferiority with respect to binary 

endpoints

 

Abstract :  When a new treatment is compared to an established one in a randomized 

study, it is standard practice to statistically test for equivalence 

(or for non-inferiority) rather than for significance. When the 

endpoint is binary, one usually compares two treatments using either 

an odds-ratio or a difference of proportions. In this talk, we propose 

a mixed approach which uses an odds-ratio to define "practical 

equivalence" and which uses then a difference of proportions to show 

non-inferiority. The mixed approach is shown to be more powerful than 

the conventional odds-ratio approach when the efficiency of the 

established treatment is known (with good precision) and when it is 

high (with more than 50% of success), as is often the case. The gain 

of power achieved may lead in turn to a substantial reduction in the sample size needed to prove non-inferiority.

The method can be generalized to ordinal endpoints.

 

This is a joint work with Burkhardt Seifert, University of Zurich

 


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