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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...

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Detalles Bibliográficos
Autores principales: Miao, Guanhong, Liao, Jason J. Z., Yang, Jing, Anderson, Keaven
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2023
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