English

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

Methodology 2021-05-17 v2

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 \delta-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.

Keywords

Cite

@article{arxiv.2007.02339,
  title  = {SMIM: a unified framework of Survival sensitivity analysis using Multiple Imputation and Martingale},
  author = {Shu Yang and Yilong Zhang and Guanghan Frank Liu and Qian Guan},
  journal= {arXiv preprint arXiv:2007.02339},
  year   = {2021}
}