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Frequentist rules for regulatory approval of subgroups in phase III trials: A fresh look at an old problem
BACKGROUND: The number of Phase III trials that include a biomarker in design and analysis has increased due to interest in personalised medicine. For genetic mutations and other predictive biomarkers, the trial sample comprises two subgroups, one of which, say [Formula: see text] is known or suspec...
| Autores principales: | , , , , , |
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
| Publicado: |
SAGE Publications
2021
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| Materias: | |
| Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8411475/ https://www.ncbi.nlm.nih.gov/pubmed/34077288 http://dx.doi.org/10.1177/09622802211017574 |