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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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Bibliografiske detaljer
Udgivet i:Pharm Stat
Main Authors: Weng, Yanqiu, Zhao, Wenle, Palesch, Yuko
Format: Artigo
Sprog:Inglês
Udgivet: 2012
Fag:
Online adgang: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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