Inference for heterogeneity of treatment eect in multi-center clinical trial

  • Ha, Il-Do (Department of Asset Management, Daegu Haany University)
  • Received : 2011.04.02
  • Accepted : 2011.05.12
  • Published : 2011.05.31

Abstract

In multi-center randomized clinical trial the treatment eect may be changed over centers. It is thus important to investigate the heterogeneity in treatment eect between centers. For this, uncorrelated random-eect models assuming independence between random-eect terms have been often used, which may be a strong assumption. In this paper we propose a correlated frailty modelling approach of investigating such heterogeneity using the hierarchical-likelihood method when the outcome is time-to-event. In particular, we show how to construct a proper prediction interval for frailty, which explores graphically the potential heterogeneity for a treatment-by-center interaction term. The proposed method is illustrated via numerical studies based on data from the design of a multi-center clinical trial.

Keywords

References

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