Bayesian approach to the design and analysis of non-inferiority trials for anti-infective products.
Pharm Stat
; 13(1): 25-40, 2014.
Article
en En
| MEDLINE
| ID: mdl-23913880
ABSTRACT
In the absence of placebo-controlled trials, determining the non-inferiority (NI) margin for comparing an experimental treatment with an active comparator is based on carefully selected well-controlled historical clinical trials. With this approach, information on the effect of the active comparator from other sources including observational studies and early phase trials is usually ignored because of the need to maintain active comparator effect across trials. This may lead to conservative estimates of the margin that translate into larger sample-size requirements for the design and subsequent frequentist analysis, longer trial durations, and higher drug development costs. In this article, we provide methodological approaches to determine NI margins that can utilize all relevant historical data through a novel power adjusted Bayesian meta-analysis, with Dirichlet process priors, that puts ordered weights on the amount of information a set of data contributes. We also provide a Bayesian decision rule for the non-inferiority analysis that is based on a broader use of available prior information and a sample-size determination that is based on this Bayesian decision rule. Finally, the methodology is illustrated through several examples.
Palabras clave
Texto completo:
1
Bases de datos:
MEDLINE
Asunto principal:
Proyectos de Investigación
/
Ensayos Clínicos como Asunto
/
Teorema de Bayes
/
Antiinfecciosos
Tipo de estudio:
Clinical_trials
/
Observational_studies
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Prognostic_studies
/
Systematic_reviews
Límite:
Humans
Idioma:
En
Revista:
Pharm Stat
Asunto de la revista:
FARMACOLOGIA
Año:
2014
Tipo del documento:
Article
País de afiliación:
Estados Unidos