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Activity Number: 118
Type: Topic Contributed
Date/Time: Monday, August 10, 2015 : 8:30 AM to 10:20 AM
Sponsor: Biopharmaceutical Section
Abstract #316230 View Presentation
Title: Methods for Increasing Power in Vaccine Efficacy Trials
Author(s): David Benkeser* and Peter B. Gilbert and Marco Carone
Companies: and Fred Hutchinson Cancer Research Center and University of Washington
Keywords: vaccine ; semiparametric efficiency ; targeted minimum loss-based estimation ; HIV ; clinical trial
Abstract:

There has recently been increased interest in developing efficient statistical methods that provide improved power for detecting treatment effects. We discuss several of these methodologies that are particularly appealing for preventative vaccine efficacy trials. The first method that we consider increases power through adjustment for prognostic baseline covariates. For many disease endpoints, these covariates are routinely collected, for example sexual risk behaviors in HIV vaccine efficacy trials. We focus on the challenges presented when covariates are high-dimensional and leverage the framework of targeted minimum loss-based estimation to provide a way forward in these cases. We also consider increasing power by incorporating known bounds on the probability of the disease endpoint of interest. These methods are particularly appealing when the outcome of interest is rare, such as the analysis of adverse events or the assessment of vaccine efficacy against an uncommon genotype of the disease-causing pathogen. The methods also allow relaxing the random dropout assumption. Our methods are evaluated using simulations and illustrated using examples from HIV vaccine efficacy trials.


Authors who are presenting talks have a * after their name.

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