Estimating a treatment effect with repeated measurements accounting for varying effectiveness duration

Y. Q. Chen, J. Yang, S. Cheng, J. B. Jackson

Research output: Contribution to journalArticlepeer-review

Abstract

To assess treatment efficacy in clinical trials, certain clinical outcomes are repeatedly measured over time for the same subject. The difference in their means may characterize a treatment effect. Since treatment effectiveness lag and saturation times may exist, erosion of treatment effect often occurs during the observation period. Instead of using models based on ad hoc parametric or purely nonparametric time-varying coefficients, we model the treatment effectiveness durations, which are the time intervals between the lag and saturation times. Then we use some mean response models to include such treatment effectiveness durations. Our methodology is demonstrated by simulations and analysis of a landmark HIV/AIDS clinical trial of short-course nevirapine against mother-to-child HIV vertical transmission during labour and delivery.

Original languageEnglish (US)
Pages (from-to)387-402
Number of pages16
JournalBiometrika
Volume94
Issue number2
DOIs
StatePublished - Jun 2007

Keywords

  • Effect erosion
  • HIV/AIDS clinical trial
  • Longitudinal study
  • Mean response model
  • Time-varying coefficient

ASJC Scopus subject areas

  • Agricultural and Biological Sciences(all)
  • Agricultural and Biological Sciences (miscellaneous)
  • Statistics and Probability
  • Mathematics(all)
  • Applied Mathematics

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