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Activity Number: 187 - Surrogate Markers and the Role of Mediation Analysis in Drug Development
Type: Invited
Date/Time: Tuesday, August 10, 2021 : 1:30 PM to 3:20 PM
Sponsor: Biometrics Section
Abstract #314427
Title: A Survival Mediation Model with Bayesian Model Averaging
Author(s): Jie Zhou* and Peng Wei and Brian Hobbs
Companies: Cleveland Clinic Foundation and The University of Texas MD Anderson Cancer Center and The University of Texas at Austin
Keywords: Bayesian model averaging; Sarrogate markers; Mediation analysis; Oncology

Determining the extent to which a patient is benefiting from cancer therapy is challenging. Criteria for quantifying the extent of "tumor response" observed within a few cycles of treatment have been established for various types of solid as well as hematologic malignancies. These measures comprise the primary endpoints of phase II trials. With nearly two thirds of phase III oncology trials failing to achieve statistically significant results, researchers continue to refine and propose new surrogate endpoints. This article presents a Bayesian framework for studying relationships among treatment, tumor response and survival. Combining classical components of mediation analysis with Bayesian model averaging, the methodology is robust to model mis-specification among various possible relationships among the observable entities. Posterior inference is demonstrated via application to a randomized controlled phase III trial in metastatic colorectal cancer. Moreover, the article details posterior predictive distributions of survival and statistical metrics for quantifying the extent of direct and indirect, or tumor response mediated, treatment effects.

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

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