Modelling clustered survival data from multicentre clinical trials

Stat Med. 2004 Feb 15;23(3):369-88. doi: 10.1002/sim.1599.


In randomized clinical trials, subjects are recruited at multiple study centres. Factors that vary across centres may exert a powerful independent influence on study outcomes. A common problem is how to incorporate these centre effects into the analysis of censored time-to-event data. We survey various methods and find substantial advantages in the gamma frailty model. This approach compares favourably with competing methods and appears minimally affected by violation of the assumption of a gamma-distributed frailty. Recent computational advances make use of the gamma frailty model a practical and appealing tool for addressing centre effects in the analysis of multicentre trials.

Publication types

  • Comparative Study
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Humans
  • Models, Statistical*
  • Multicenter Studies as Topic / statistics & numerical data*
  • Randomized Controlled Trials as Topic / statistics & numerical data
  • Survival Analysis*
  • United States