The inclusion of real world evidence in clinical development planning

The inclusion of real world evidence in clinical development planning

Abstract Background When designing studies it is common to search the literature to investigate variability estimates to use in sample size calculations. Proprietary data of previously designed trials in a particular indication are also used to obtain estimates of variability. Estimates of treatment...

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Bibliographic Details
Main Authors: Reynaldo Martina, David Jenkins, Sylwia Bujkiewicz, Pascale Dequen, Keith Abrams, on behalf of GetReal Workpackage 1
Format: Article
Language:English
Published: BMC 2018-08-01
Series:Trials
Subjects:
Network meta-analysis
Relapse rate
Negative binomial model
Clinical development plan
Sample size
Clinical trial simulation
Online Access:http://link.springer.com/article/10.1186/s13063-018-2769-2

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http://link.springer.com/article/10.1186/s13063-018-2769-2

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