Sequential tests for noninferiority and superiority.
Biometrics
; 59(1): 106-14, 2003 Mar.
Article
en En
| MEDLINE
| ID: mdl-12762447
The problem of simultaneous sequential tests for noninferiority and superiority of a treatment, as compared to an active control, is considered in terms of continuous hierarchical families of one-sided null hypotheses, in the framework of group sequential and adaptive two-stage designs. The crucial point is that the decision boundaries for the individual null hypotheses may vary over the parameter space. This allows one to construct designs where, e.g., a rigid stopping criterion is chosen, rejecting or accepting all individual null hypotheses simultaneously. Another possibility is to use monitoring type stopping boundaries, which leave some flexibility to the experimenter: he can decide, at the interim analysis, whether he is satisfied with the noninferiority margin achieved at this stage, or wants to go for more at the second stage. In the case where he proceeds to the second stage, he may perform midtrial design modifications (e.g., reassess the sample size). The proposed approach allows one to "spend," e.g., less of alpha for an early proof of noninferiority than for an early proof of superiority, and is illustrated by typical examples.
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Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Proyectos de Investigación
/
Ensayos Clínicos Controlados Aleatorios como Asunto
/
Estadística como Asunto
Tipo de estudio:
Clinical_trials
/
Prognostic_studies
Límite:
Humans
Idioma:
En
Revista:
Biometrics
Año:
2003
Tipo del documento:
Article
País de afiliación:
Austria
Pais de publicación:
Estados Unidos