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ASSESSING THE IMPACT OF SAFETY MONITORING ON THE EFFICACY ANALYSIS IN LARGE PHASE III GROUP SEQUENTIAL TRIALS WITH NON-TRIVIAL SAFETY EVENT RATE
In Phase III clinical trials for life-threatening conditions, some serious but expected adverse events, such as early deaths or congestive heart failure, are often treated as the secondary or co-primary endpoint, and are closely monitored by the data and safety monitoring committee. A naïve group se...
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| Publicado no: | J Biopharm Stat |
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| Main Authors: | , , , |
| Formato: | Artigo |
| Idioma: | Inglês |
| Publicado em: |
2015
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| Assuntos: | |
| Acesso em linha: | https://ncbi.nlm.nih.gov/pmc/articles/PMC4661138/ https://ncbi.nlm.nih.gov/pubmed/26010228 https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1080/10543406.2015.1052473 |
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