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Activity Number: 233 - Statistical Considerations for Adjusting Overall Survival in Randomized Trials with Treatment Switching
Type: Topic Contributed
Date/Time: Tuesday, August 9, 2022 : 8:30 AM to 10:20 AM
Sponsor: Biopharmaceutical Section
Abstract #323237
Title: A Simulation Study of Treatment Switching Considering Delay Treatment Effect
Author(s): Songzi Li* and Jiang Li
Companies: BeiGene, Ltd. and Ph.D
Keywords: treatment switch; IPCW; RPFST; 2-Stage; immune checkpoint inhibitor
Abstract:

Treatment switching in oncology studies refers to the situation where patients in the control group switch to experimental group after disease progression and mainly driven by ethical considerations. Statistical inference on overall survival will be biased due to the confounding effects from treatment switching. In past decade, Immunotherapies are taking the center stage for cancer drug development and research. Many of these therapies, for example, immune checkpoint inhibitors, are known to have possible lag periods to achieve their full effects. In this research, we present (i) a theoretical overview of well-known statistical methods adjusting for overall survival (RPSFTM, IPCW and 2-stage), and (ii) a simulation study is performed to quantify bias of overall survival assessment via different models (native without adjustment, RPFSTM, IPCW, and 2-stage) when considering the delay treatment effect in treatment switching problem.


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