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

Abstract Details

Activity Number: 467
Type: Contributed
Date/Time: Wednesday, August 4, 2010 : 8:30 AM to 10:20 AM
Sponsor: Biometrics Section
Abstract - #307155
Title: Testing Small Center Events in Multicenter Trials Using Survival Modeling
Author(s): Usha Sita Govindarajulu*+ and Elizabeth J. Malloy and James Dziura
Companies: Brigham and Women's Hospital, Harvard Medical School and American University and Yale University
Address: , , MA, ,
Keywords: clinical trials ; Cox model ; frailty ; smoothing ; prognostic ; simulation
Abstract:

The goals of this research are to better understand and formulate the problems in multi-center clinical trials in estimating treatment effect with varying number of centers and few patients per center for rarer disease outcomes, like cancer. We modeled the heterogeneity between centers using Cox frailty models to account for the variability and assess model fit via smoothed functions of a prognostic factor to better understand how these models can be used in assessment of treatment effect. Through this simulation study, we were able to understand the effect of having few centers or few patients per center. Overall, we discovered it is better to have more patients per site and more sites. However, scenarios having a few patients per site is feasible if there are many sites.

--Usha


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