Use Simulation Tools to Compare Empirical Models in Confirmatory Trials
View Presentation *Fanhui Kong, FDA Keywords: clinical trials, informative dropouts, simulation, schizophrenia In clinical trials, patient outcomes are often measured at scheduled time intervals. Treatment effects at a pre-specified time point are often tested. Patient dropout may introduce great uncertainty in the inference of treatment effect. In particular, the possible informative dropout makes it difficult to choose statistical models for reliable inferences. Dropout mechanisms are often hard to characterize by statistical models. Therefore, comparisons of the available statistical methods are difficult to make. In this presentation, we consider a set of commonly known empirical dropout models. Simulation studies are performed to evaluate and compare the reliability of these empirical models with various patient dropout mechanisms including informative dropouts. Based on these results, we will give suggestions regarding the applicability of these empirical models in a few therapeutic areas.
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Key Dates
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April 30 - May 22, 2013
Invited Abstract Submission Open -
June 4, 2013
Online Registration Opens -
August 9 - August 23, 2013
Invited Abstract Editing -
August 23, 2013
Short Course materials due from Instructors -
August 26, 2013
Housing Deadline -
September 9, 2013
Cancellation Deadline and Registration Closes @ 11:59 pm EDT -
September 16 - September 18, 2013
Marriott Wardman Park, Washington, DC