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Optimal designs for phase II/III drug development programs including methods for discounting of phase II results
BACKGROUND: Go/no-go decisions after phase II and sample size chosen for phase III are usually based on phase II results (e.g., the treatment effect estimate of phase II). Due to the decision rule (only promising phase II results lead to phase III), treatment effect estimates from phase II that init...
| Autores principales: | , , , |
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
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BioMed Central
2020
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| Materias: | |
| Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7547445/ https://www.ncbi.nlm.nih.gov/pubmed/33036572 http://dx.doi.org/10.1186/s12874-020-01093-w |