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Setting the bar in Phase II trials: the use of historical data for determining “go / no go” decision for definitive phase III testing
BACKGROUND: Phase II trials aim to determine whether a cancer treatment is sufficiently promising to justify Phase III study. Whether an agent is declared promising in Phase II trial depends on pre-specified “null” and “alternative” rates of an outcome of interest such as tumor response. In some cas...
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| Main Authors: | , , |
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| Formato: | Artigo |
| Idioma: | Inglês |
| Publicado em: |
2007
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| Assuntos: | |
| Acesso em linha: | https://ncbi.nlm.nih.gov/pmc/articles/PMC2529160/ https://ncbi.nlm.nih.gov/pubmed/17277252 https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1158/1078-0432.CCR-06-0909 |
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