Adjusting for centre heterogeneity in multicentre clinical trials with a time-to-event outcome
(2014) Pharmaceutical Statistics : the journal of applied statistics in the pharmaceutical industry — Vol. 13, n° 2, p. 145-152 (2014)
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- Abstract
- Conducting a clinical trial at multiple study centres raises the issue of whether and how to adjust for centre heterogeneity in the statistical analysis. In this paper, weaddress this issue for multicentre clinical trials with a time-to-event outcome. Based on simulations, we show that the current practice of ignoring centre heterogeneity can be seriously misleading, and we illustrate the performances of the frailty modelling approach over competing methods. A special attention is paid to the problem of misspecification of the frailty distribution. The appendix provides sample codes in R and in SAS to perform the analyses in this paper.
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Citations
Munda, M., & Legrand, C. (2014). Adjusting for centre heterogeneity in multicentre clinical trials with a time-to-event outcome. Pharmaceutical Statistics : the journal of applied statistics in the pharmaceutical industry, 13(2), 145-152. https://doi.org/10.1002/pst.1612 (Original work published 2014)