Adaptive and repeated cumulative meta-analyses of safety data during a new drug development process.
Pharm Stat
; 14(3): 161-71, 2015.
Article
em En
| MEDLINE
| ID: mdl-25612310
ABSTRACT
During a new drug development process, it is desirable to timely detect potential safety signals. For this purpose, repeated meta-analyses may be performed sequentially on accumulating safety data. Moreover, if the amount of safety data from the originally planned program is not enough to ensure adequate power to test a specific hypothesis (e.g., the noninferiority hypothesis of an event of interest), the total sample size may be increased by adding new studies to the program. Without appropriate adjustment, it is well known that the type I error rate will be inflated because of repeated analyses and sample size adjustment. In this paper, we discuss potential issues associated with adaptive and repeated cumulative meta-analyses of safety data conducted during a drug development process. We consider both frequentist and Bayesian approaches. A new drug development example is used to demonstrate the application of the methods.
Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Metanálise como Assunto
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Estatística como Assunto
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Ensaios Clínicos como Assunto
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Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos
Tipo de estudo:
Diagnostic_studies
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Prognostic_studies
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Risk_factors_studies
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Systematic_reviews
Limite:
Humans
Idioma:
En
Ano de publicação:
2015
Tipo de documento:
Article