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Activity Number: 324
Type: Contributed
Date/Time: Tuesday, August 4, 2009 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract - #305483
Title: Handling Missing Outcome Data When Estimating and Testing the Average Causal Effect of Treatment for a Subset Selected by a Post-Randomization Event
Author(s): Robin Mogg*+ and Devan V. Mehrotra and Peter Gilbert and Thomas Ten Have and Marshall Joffe
Companies: Merck Research Laboratories and Merck Research Laboratories and University of Washington/Fred Hutchinson Cancer Research Center and University of Pennsylvania and University of Pennsylvania
Address: , , ,
Keywords: Causal inference ; Missing at random ; Principal stratification ; Selection bias ; Sensitivity analysis
Abstract:

Principal stratification based methods to estimate and test the average causal effect (ACE) of treatment on an outcome measured after a post-randomization event have been described in considerable detail. Selection models that identify the ACE can be applied in a sensitivity analysis to quantify how the ACE varies over a range of presumed bias. The validity of these methods relies on an often untenable MCAR missing data assumption. Inverse weighting and robust likelihood approaches have been described under a more plausible MAR assumption. We use simulation to compare these methods with a MI-based approach to accommodate MAR missing outcome data under various conditions. We illustrate the approaches using data from an HIV vaccine clinical trial.


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