JSM 2011 Online Program

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Abstract Details

Activity Number: 531
Type: Roundtables
Date/Time: Wednesday, August 3, 2011 : 12:30 PM to 1:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #301344
Title: Identifying Treatment-Effect Heterogeneity in Clinical Trials Using Subpopulation Treatment Effect Pattern Plots
Author(s): Ann A. Lazar*+ and Wai-ki Yip and Bernard F. Cole and Marco Bonetti and Richard D. Gelber
Companies: University of California at San Francisco and Harvard School of Public Health and University of Vermont and Bocconi University and Harvard School of Public Health/Dana-Farber Cancer Institute
Address: 3333 California Street Ste 495, San Francisco, CA, 94119, USA
Keywords: Competing Risks ; Biomarkers ; Kaplan-Meier ; Breast Cancer ; Hazard Ratio ; Interaction
Abstract:

This session will focus on how to identify whether a subgroup of patients responds differently to a treatment than the overall population. In particular, we will discuss Subpopulation Treatment Effect Pattern Plots (STEPP), an intuitive graphical method designed to evaluate treatment-effect heterogeneity. The results from STEPP enhance the interpretation of clinical trial results needed for making individual patient decisions. Examples from a Phase III clinical trial will be included along with the associated code from the R STEPP software package.


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