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Related Experiment Videos

A random effects model for multivariate failure time data from multicenter clinical trials.

J Cai1, P K Sen, H Zhou

  • 1Department of Biostatistics, The University of North Carolina at Chapel Hill, 27599-7400, USA. cai@bios.unc.edu

Biometrics
|April 25, 2001
PubMed
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This study introduces a new random effects model for analyzing multivariate failure time data in multicenter clinical trials. The model accurately assesses treatment effects and accounts for variability between study centers.

Area of Science:

  • Biostatistics
  • Clinical Trials
  • Survival Analysis

Background:

  • Multivariate failure time data analysis is crucial in clinical trials.
  • Assessing mean treatment effects in multicenter studies requires accounting for center variability.
  • Existing models may not adequately capture the complexity of such data.

Purpose of the Study:

  • To propose a random effects model for multivariate failure time data.
  • To develop an estimating equation for the mean hazard ratio parameter.
  • To assess the mean treatment effect in multicenter clinical trials.

Main Methods:

  • Developed a random effects model for multivariate failure time data.
  • Proposed an estimating equation for the mean hazard ratio.

Related Experiment Videos

  • Utilized large sample theory for variance estimation.
  • Conducted simulations to evaluate performance.

    • Main Results:

    • The proposed estimator is consistent and asymptotically normally distributed.
    • Simulation results show good performance in finite samples.
    • The proposed variance estimator corrects bias compared to naive methods.
    • Analysis of clinical trial data revealed higher treatment effect variability.

    Conclusions:

    • The random effects model effectively analyzes multivariate failure time data in multicenter trials.
    • The proposed methods provide reliable estimation of mean treatment effects.
    • The findings highlight the importance of accounting for center variability in clinical trial analysis.