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...

Descripción completa

Detalles Bibliográficos
Autores principales: Erdmann, Stella, Kirchner, Marietta, Götte, Heiko, Kieser, Meinhard
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2020
Materias:
Research Article
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

Internet

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

Ejemplares similares