[The Choice of Priorities in Contemporary Comparative Trials: Superiority vs non Inferiority. Causes and Effects].
Kardiologiia
; 60(10): 107-112, 2020 Nov 12.
Article
en Ru
| MEDLINE
| ID: mdl-33228513
The article compares two statistical approaches, which are commonly used in current comparative studies, a hypothesis that a drug is superior over another one (superiority) and a hypothesis that a drug is not inferior to another one in the efficacy and safety (non-inferiority). Using the example of specific studies, the difference between the methods and the tasks, for the solution of which one or another method should be applied, are shown. In order to prove the superiority in efficacy and safety of a new drug over an existing one, only a statistical approach that uses the "superiority" hypothesis is applicable. Studies using the "non-inferiority" hypothesis are generally used for comparing drugs, which are not considerably different in their efficacy, but the study drug has other advantages in the administration, storage, tolerability etc. The choice of statistical method is determined exclusively by the task of the study.
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Proyectos de Investigación
/
Ensayos Clínicos como Asunto
Tipo de estudio:
Etiology_studies
Límite:
Humans
Idioma:
Ru
Revista:
Kardiologiia
Año:
2020
Tipo del documento:
Article
Pais de publicación:
Rusia