Semiparametric estimation of treatment effect with time-lagged response in the presence of informative censoring

Lifetime Data Anal. 2011 Oct;17(4):566-93. doi: 10.1007/s10985-011-9199-8. Epub 2011 Jun 26.

Abstract

In many randomized clinical trials, the primary response variable, for example, the survival time, is not observed directly after the patients enroll in the study but rather observed after some period of time (lag time). It is often the case that such a response variable is missing for some patients due to censoring that occurs when the study ends before the patient's response is observed or when the patients drop out of the study. It is often assumed that censoring occurs at random which is referred to as noninformative censoring; however, in many cases such an assumption may not be reasonable. If the missing data are not analyzed properly, the estimator or test for the treatment effect may be biased. In this paper, we use semiparametric theory to derive a class of consistent and asymptotically normal estimators for the treatment effect parameter which are applicable when the response variable is right censored. The baseline auxiliary covariates and post-treatment auxiliary covariates, which may be time-dependent, are also considered in our semiparametric model. These auxiliary covariates are used to derive estimators that both account for informative censoring and are more efficient then the estimators which do not consider the auxiliary covariates.

Publication types

  • Research Support, N.I.H., Extramural

MeSH terms

  • Anti-HIV Agents / administration & dosage
  • Anti-HIV Agents / therapeutic use
  • CD4 Lymphocyte Count
  • Data Interpretation, Statistical*
  • HIV / growth & development
  • HIV Infections / drug therapy
  • Humans
  • Models, Statistical*
  • Randomized Controlled Trials as Topic / methods*
  • Treatment Outcome*

Substances

  • Anti-HIV Agents