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Related Experiment Videos

Modelling clustered survival data from multicentre clinical trials.

David V Glidden1, Eric Vittinghoff

  • 1Department of Epidemiology and Biostatistics, University of California-San Francisco, 500 Parnassus Avenue, MU-420 West, Box 0560, San Francisco, CA 94143-0560, U.S.A. dave@biostat.ucsf.edu

Statistics in Medicine
|January 30, 2004
PubMed
Summary

Analyzing multicentre trial data requires accounting for center effects. The gamma frailty model offers a robust and practical solution for censored time-to-event data analysis, outperforming other methods.

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Area of Science:

  • Biostatistics
  • Clinical Trials Methodology
  • Survival Analysis

Background:

  • Multicentre randomized clinical trials involve subjects from various study locations.
  • Factors that differ across these centres can significantly impact study outcomes.
  • Incorporating these centre effects into the analysis of censored time-to-event data is a common challenge.

Purpose of the Study:

  • To survey methods for analyzing censored time-to-event data in multicentre trials.
  • To identify and evaluate advantageous approaches for incorporating centre effects.
  • To highlight the utility of the gamma frailty model for this purpose.

Main Methods:

  • Survey of existing statistical methods for handling centre effects in survival analysis.
  • Evaluation of the gamma frailty model for analysing censored time-to-event data from multicentre trials.

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  • Assessment of the model's performance and robustness, including sensitivity to the frailty distribution assumption.
  • Main Results:

    • The gamma frailty model demonstrates substantial advantages over competing methods.
    • This approach is minimally affected by violations of the gamma-distributed frailty assumption.
    • Recent computational advancements make the gamma frailty model a practical tool.

    Conclusions:

    • The gamma frailty model is a practical and appealing tool for addressing centre effects in multicentre trials.
    • It offers a robust and effective method for analysing censored time-to-event data.
    • This model provides a favourable comparison to alternative analytical approaches.