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The “RCT augmentation”: a novel simulation method to add patient heterogeneity into phase III trials

BACKGROUND: Phase III randomized controlled trials (RCT) typically exclude certain patient subgroups, thereby potentially jeopardizing estimation of a drug’s effects when prescribed to wider populations and under routine care (“effectiveness”). Conversely, enrolling heterogeneous populations in RCTs...

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Detalles Bibliográficos
Autores principales: Karcher, Helene, Fu, Shuai, Meng, Jie, Ankarfeldt, Mikkel Zöllner, Efthimiou, Orestis, Belger, Mark, Haro, Josep Maria, Abenhaim, Lucien, Nordon, Clementine
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6035409/
https://www.ncbi.nlm.nih.gov/pubmed/29980181
http://dx.doi.org/10.1186/s12874-018-0534-6