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A gated group sequential design for seamless Phase II/III trial with subpopulation selection
BACKGROUND: Due to the high cost and high failure rate of Phase III trials where a classical group sequential design (GSD) is usually used, seamless Phase II/III designs are more and more popular to improve trial efficiency. A potential attraction of Phase II/III design is to allow a randomized proo...
Autores principales: | , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9809114/ https://www.ncbi.nlm.nih.gov/pubmed/36597042 http://dx.doi.org/10.1186/s12874-022-01825-0 |