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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...
Autores principales: | Karcher, Helene, Fu, Shuai, Meng, Jie, Ankarfeldt, Mikkel Zöllner, Efthimiou, Orestis, Belger, Mark, Haro, Josep Maria, Abenhaim, Lucien, Nordon, Clementine |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2018
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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 |
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