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Activity Number: 233
Type: Topic Contributed
Date/Time: Monday, August 10, 2015 : 2:00 PM to 3:50 PM
Sponsor: International Chinese Statistical Association
Abstract #316980
Title: Comparing Several Recensoring Methods of RPSFT Model for the Analysis of OS Data Adjusted for Treatment Switching in Phase III Clinical Trials
Author(s): Jason Yuan* and Connie Lee
Companies: Agios Pharmaceuticals and Takeda Pharmaceuticals
Keywords: RPSFT ; OS ; Phase 3 ; cross over ; re-censoring ; treatment switching
Abstract:

RPSFT (Rank Preserving Structural Failure Time) model is one of the widely used methods in analyzing adjusted OS data after patients progressed and switched from control group to active group in the Phase III oncology trials. The current recommended re-censoring rule for censored patients of RPSFT has limitation. It might be too conservative causing bias toward active treatment arm and inflated type 1 error rate based on the model based variance estimator. Therefore, here we consider several different ways of doing re-censoring and compare their performance in terms of power and type-1 error rate through simulations based on a Phase 3 randomized study for multiple myeloma patients. The comparison results demonstrate that the current re-censoring method in RPSFT could be improved.


Authors who are presenting talks have a * after their name.

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