Seamless phase IIa/IIb adaptive design with the same primary endpoint for proof of concept and dose finding

This paper considers combining a proof of concept (POC) study and a dose finding (DF) study where the POC and the DF share the same primary endpoint. An example based on real study conditions shows that compared to a conventional design the proposed adaptive design tests more active doses, with a sm...

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Detalles Bibliográficos
Autores principales: Yuan, Jiacheng, Radecki, Daniel, Bugarin, Denise, Geib, Till, Zhou, Jihao, Liu, Jeen
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier 2018
Materias:
Article
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6039539/
https://www.ncbi.nlm.nih.gov/pubmed/30003170
http://dx.doi.org/10.1016/j.conctc.2018.06.006
Descripción
Sumario:This paper considers combining a proof of concept (POC) study and a dose finding (DF) study where the POC and the DF share the same primary endpoint. An example based on real study conditions shows that compared to a conventional design the proposed adaptive design tests more active doses, with a smaller sample size and a shorter overall duration leading to a budget saving of 30% in study operations.

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