This is the program for the 2010 Joint Statistical Meetings in Vancouver, British Columbia.

Abstract Details

Activity Number: 583
Type: Contributed
Date/Time: Wednesday, August 4, 2010 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #308135
Title: Sensitivity Analysis for PFS
Author(s): Alicia Zhang*+ and Alan Rong and Ying Tian and Michael Wolf
Companies: Amgen Inc. and Amgen Inc. and Amgen Inc. and Amgen Inc.
Address: One Amgen Center Dr., Thousand Oaks, CA, 91320, USA
Keywords: sensitivity analysis ; PFS ; oncology therapeutic trials

Sensitivity analysis for PFS has become increasingly important in oncology therapeutic trials due to the fact that more trials use PFS (from central review) as the primary endpoint. Potential biases could mislead the primary analysis results and hence the impact should be assessed. Those biases come from many aspects including the tumor assessment frequency, tumor assessment interval, truncation of central review by local disease progression, open-label study and use of the subsequent anti-cancer therapies. In this presentation, we will present some key issues for PFS analyses raised from several P3 mCRC studies and propose some sensitivity analysis methods with different degrees of conservativeness to address these issues. Interpretation of those analyses including the impact to the estimation of treatment effect and the control of type 1 error rate will be discussed.

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