Multipopulation Tailoring Clinical Trials: Design, Analysis, and Inference Considerations.
Ther Innov Regul Sci
; 48(4): 453-462, 2014 Jul.
Article
en En
| MEDLINE
| ID: mdl-30235572
ABSTRACT
Several recent publications have focused on statistical considerations that arise in multipopulation tailoring clinical trials that evaluate treatment effect in an overall patient population as well as one or more predefined subpopulations. This paper presents a decision-making framework applicable to these trials and evaluates the operating characteristics of this framework versus one based solely on the results of primary hypothesis tests. The operating characteristics are presented as rates of applicable errors, known as influence errors and interaction errors.
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Base de datos:
MEDLINE
Tipo de estudio:
Prognostic_studies
Idioma:
En
Revista:
Ther Innov Regul Sci
Año:
2014
Tipo del documento:
Article