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Activity Number: 55 - Non-Proportional Hazards in Clinical Trials: Challenges and Opportunities
Type: Topic Contributed
Date/Time: Sunday, July 29, 2018 : 4:00 PM to 5:50 PM
Sponsor: Section on Statistical Graphics
Abstract #329959
Title: Design and Analysis of Cancer Immunotherapy Trials with Potential Violation of Proportional Hazards Assumption
Author(s): Xiaofei Wang* and Guangyu Yang
Companies: Duke University School of Medicine and University of Michigan
Keywords: cancer clinical trials; immunotherapy ; non-proportional hazards ; design and analysis

A recent surge of cancer immunotherapy trials has revealed both a great potential of such treatments over standard chemotherapy or placebo and the significant challenges of appropriately designing and analyzing such trials. Delayed treatment effect and crossover after progression are among the reasons leading to a violation of proportional hazards (PH) assumption, which is the bedrock for survival analysis methods, such as log rank test and Cox PH regression, for correct and efficient inference on treatment effect. We systematically review the results of immunotherapy trials of advanced non-small cell lung cancers published in the past decade and provide assessment on the extent of PH violation and its impact of clinical trial findings. We also discuss potential solutions to appropriately design, monitor and analyze clinical trials where non-proportional hazards data are expected. One focus is to answer whether alternative methods, including weighted log rank test and restricted means survival (RMST) ratio, perform better relative to the standard methods.

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

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