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Activity Number: 172
Type: Contributed
Date/Time: Monday, August 4, 2014 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract #311335 View Presentation
Title: Considerations in Event Projection for Double-Blinded Oncology Trials
Author(s): Peng Sun*+ and Grace Zhang
Companies: and GlaxoSmithKline
Keywords: Oncology ; Event projection ; Bayesian
Abstract:

In double-blinded oncology trials with either PFS or OS as the primary endpoint, event projection is generally facilitated by fitting a parametric model to the blinded data. However, such an approach is problematic since the underlying data come from two distinct distributions. In this paper, we explore alternative approaches that conform to the underlying data generating process, such as a Bayesian model with treatment assignment as unknown parameters. In addition, practical considerations in event projection, such as the importance of accounting for data entry lag, will be discussed.


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