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Impact of safety monitoring on error probabilities of binary efficacy outcome analyses in large phase III group sequential trials

In phase III clinical trials, some adverse events may not be rare or unexpected and can be considered as a primary measure for safety, particularly in trials of life-threatening conditions, such as stroke or traumatic brain injury. In some clinical areas, efficacy endpoints may be highly correlated...

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Detalhes bibliográficos
Publicado no:Pharm Stat
Main Authors: Weng, Yanqiu, Zhao, Wenle, Palesch, Yuko
Formato: Artigo
Idioma:Inglês
Publicado em: 2012
Assuntos:
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC4294559/
https://ncbi.nlm.nih.gov/pubmed/22589042
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1002/pst.1520
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