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arXiv · 2007.02339

SMIM: a unified framework of Survival sensitivity analysis using Multiple Imputation and Martingale

Shu Yang·Yilong Zhang·Guanghan Frank Liu·Qian Guan
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Abstract

Censored survival data are common in clinical trial studies. We propose a unified framework for sensitivity analysis to censoring at random in survival data using multiple imputation and martingale, called SMIM. The proposed framework adopts the δ-adjusted and control-based models, indexed by the sensitivity parameter, entailing censoring at random and a wide collection of censoring not at random assumptions. Also, it targets for a broad class of treatment effect estimands defined as functionals of treatment-specific survival functions, taking into account of missing data due to censoring. Multiple imputation facilitates the use of simple full-sample estimation; however, the standard Rubin's combining rule may overestimate the variance for inference in the sensitivity analysis framework. We decompose the multiple imputation estimator into a martingale series based on the sequential construction of the estimator and propose the wild bootstrap inference by resampling the martingale series. The new bootstrap inference has a theoretical guarantee for consistency and is computationally efficient compared to the non-parametric bootstrap counterpart. We evaluate the finite-sample performance of the proposed SMIM through simulation and an application on a HIV clinical trial.

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Shu Yang, Yilong Zhang, Guanghan Frank Liu, Qian Guan. 2021-05-14. SMIM: a unified framework of Survival sensitivity analysis using Multiple Imputation and Martingale. https://arxiv.org/abs/2007.02339

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