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Abstract Details

Activity Number: 522
Type: Contributed
Date/Time: Wednesday, August 1, 2012 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract - #305401
Title: Considering Efficacy in Tumor Genotypes in a Two-Stage Adaptive Design for Oncology Trials
Author(s): Jinwei Yuan*+
Companies: ICON Clinical Research
Address: 303 Twin Dolphin Drive, Suite 600, Redwood City, CA, 94065, United States
Keywords: survival analysis ; oncology trials ; genotype ; Bayesian ; WinBUGS

In a standard two-stage adaptive oncology trial, an interim analysis is performed after Stage One for purposes of deciding whether to stop for futility or efficacy, or continue to Stage Two. The interim analysis is performed on the primary endpoint, typically progression-free survival (PFS) in the intent-to-treat (ITT) population. By using a Bayesian hierarchical probability model (BHM) in WinBUGS , the efficacy in tumor genotypes can also be taken into account. This approach allows for adaptation based not only on the observed primary PFS but also on observed PFS across tumor genotypes at the time of the interim analysis.

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