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

Abstract Details

Activity Number: 256
Type: Contributed
Date/Time: Monday, August 2, 2010 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #307292
Title: Longitudinal Methods for Analysis of Tumor Burden Data
Author(s): Ritwik Sinha*+ and Aparna B. Anderson
Companies: Bristol-Myers Squibb and Bristol-Myers Squibb
Address: 5 Research Parkway, Wallingford, CT, 06492,
Keywords: Tumor Burden ; Longitudinal Data ; Mixed Model ; Informative Missingness ; PFS ; Progression

Overall survival is the gold standard measure for evaluating treatment effect in oncology. But it is postulated that the primary mechanism through which most anti-cancer treatments provide benefit is the tumor burden process. Surrogate measures of clinical benefit in oncology, e.g., objective response rate or progression-free survival, are incomplete measures of this process. We propose to analyze the treatment effect on tumor growth kinetics a longitudinal approaches. The method is an application of linear mixed models. The proposed analyses can be performed in early phase clinical trials to better characterize treatment effect and thereby inform decision-making.

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