MSM Versus IPCW in Survival Analysis for Adjusting Confounding Due to Taking Alternative Therapy in Phase III Oncology Clinical Trials

• Activity Number: 233
• Type: Topic Contributed
• Date/Time: Monday, August 10, 2015 : 2:00 PM to 3:50 PM
• Sponsor: International Chinese Statistical Association
• Author(s): Jing Xu*
• Companies: Takeda Pharmaceuticals
• Keywords: Causal Inference ; MSM ; IPCW ; IPTW ; time dependent confounding ; survival analysis

Abstract

In late phase oncology clinical trials, it is common for patients in both active and control arms taking alternative therapy after disease progression, which causes time-dependent confounding for the ITT analysis. Thus, ITT analysis no longer measures the true biologic efficacy and may underestimate the true treatment effect size on overall survival. Both MSM and IPCW methods can be used to adjust for time dependent confounding under the alternative therapy setting. In this talk, we will compare the relative performance of these two methods based on a case study using real trial data. Various measures, which have been developed lately, to improve the precision and reduce bias for the survival analysis when applying these two methods in phase III randomized trials will be presented in the talk.