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Inferences on relative failure rates in stratified mark-specific proportional hazards models with missing marks, with application to human immunodeficiency virus vaccine efficacy trials

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  • Peter B. Gilbert
  • Yanqing Sun

Abstract

type="main" xml:id="rssc12067-abs-0001"> The paper develops hypothesis testing procedures for the stratified mark-specific proportional hazards model in the presence of missing marks. The motivating application is preventive human immunodeficiency virus (HIV) vaccine efficacy trials, where the mark is the genetic distance of an infecting HIV sequence to an HIV sequence represented inside the vaccine. The test statistics are constructed on the basis of two-stage efficient estimators, which utilize auxiliary predictors of the missing marks. The asymptotic properties and finite sample performances of the testing procedures are investigated, demonstrating double robustness and effectiveness of the predictive auxiliaries to recover efficiency. The methods are applied to the RV144 vaccine trial.

Suggested Citation

  • Peter B. Gilbert & Yanqing Sun, 2015. "Inferences on relative failure rates in stratified mark-specific proportional hazards models with missing marks, with application to human immunodeficiency virus vaccine efficacy trials," Journal of the Royal Statistical Society Series C, Royal Statistical Society, vol. 64(1), pages 49-73, January.
    • Handle: RePEc:bla:jorssc:v:64:y:2015:i:1:p:49-73
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    File URL: http://hdl.handle.net/10.1111/rssc.2014.64.issue-1
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    Citations

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    Cited by:

    1. Fei Heng & Yanqing Sun & Seunggeun Hyun & Peter B. Gilbert, 2020. "Analysis of the time-varying Cox model for the cause-specific hazard functions with missing causes," Lifetime Data Analysis: An International Journal Devoted to Statistical Methods and Applications for Time-to-Event Data, Springer, vol. 26(4), pages 731-760, October.
    2. Guangren Yang & Yanqing Sun & Li Qi & Peter B. Gilbert, 2017. "Estimation of Stratified Mark-Specific Proportional Hazards Models Under Two-Phase Sampling with Application to HIV Vaccine Efficacy Trials," Statistics in Biosciences, Springer;International Chinese Statistical Association, vol. 9(1), pages 259-283, June.
    3. Yanqing Sun & Li Qi & Fei Heng & Peter B. Gilbert, 2020. "A hybrid approach for the stratified mark‐specific proportional hazards model with missing covariates and missing marks, with application to vaccine efficacy trials," Journal of the Royal Statistical Society Series C, Royal Statistical Society, vol. 69(4), pages 791-814, August.
    4. Dongxiao Han & Liuquan Sun & Yanqing Sun & Li Qi, 2017. "Mark-specific additive hazards regression with continuous marks," Lifetime Data Analysis: An International Journal Devoted to Statistical Methods and Applications for Time-to-Event Data, Springer, vol. 23(3), pages 467-494, July.
    5. Craig A Magaret & David C Benkeser & Brian D Williamson & Bhavesh R Borate & Lindsay N Carpp & Ivelin S Georgiev & Ian Setliff & Adam S Dingens & Noah Simon & Marco Carone & Christopher Simpkins & Dav, 2019. "Prediction of VRC01 neutralization sensitivity by HIV-1 gp160 sequence features," PLOS Computational Biology, Public Library of Science, vol. 15(4), pages 1-35, April.

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