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

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

Abstract 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...

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Bibliographic Details
Main Authors: Helene Karcher, Shuai Fu, Jie Meng, Mikkel Zöllner Ankarfeldt, Orestis Efthimiou, Mark Belger, Josep Maria Haro, Lucien Abenhaim, Clementine Nordon, on behalf of the GetReal Consortium Work Package 2
Format: Article
Language:English
Published: BMC 2018-07-01
Series:BMC Medical Research Methodology
Subjects:
Patient heterogeneity
External validity
Real-world
Pragmatic trials
Clinical drug development
Optimal trial design
Online Access:http://link.springer.com/article/10.1186/s12874-018-0534-6

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http://link.springer.com/article/10.1186/s12874-018-0534-6

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