Group-Sequential Strategies in Clinical Trials with Multiple Co-Primary Outcomes.
Stat Biopharm Res
; 7(1): 36-54, 2015.
Article
en En
| MEDLINE
| ID: mdl-25844122
ABSTRACT
We discuss the decision-making frameworks for clinical trials with multiple co-primary endpoints in a group-sequential setting. The decision-making frameworks can account for flexibilities such as a varying number of analyses, equally or unequally spaced increments of information and fixed or adaptive Type I error allocation among endpoints. The frameworks can provide efficiency, i.e., potentially fewer trial participants, than the fixed sample size designs. We investigate the operating characteristics of the decision-making frameworks and provide guidance on constructing efficient group-sequential strategies in clinical trials with multiple co-primary endpoints.
Texto completo:
1
Bases de datos:
MEDLINE
Tipo de estudio:
Guideline
/
Prognostic_studies
Idioma:
En
Revista:
Stat Biopharm Res
Año:
2015
Tipo del documento:
Article
País de afiliación:
Japón