Lifetime Data Anal - Semiparametric estimation of treatment effect with time-lagged response in the presence of informative censoring.

Tópicos

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Resumo

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.

Resumo Limpo

mani random clinic trial primari respons variabl exampl surviv time observ direct patient enrol studi rather observ period time lag time often case respons variabl miss patient due censor occur studi end patient respons observ patient drop studi often assum censor occur random refer noninform censor howev mani case assumpt may reason miss data analyz proper estim test treatment effect may bias paper use semiparametr theori deriv class consist asymptot normal estim treatment effect paramet applic respons variabl right censor baselin auxiliari covari posttreat auxiliari covari may timedepend also consid semiparametr model auxiliari covari use deriv estim account inform censor effici estim consid auxiliari covari

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