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J Biopharm Stat. 2014;24(4):908-23. doi: 10.1080/10543406.2014.901346.

Sample size determination in shared frailty models for multivariate time-to-event data.

Author information

1
a Global Research Operation, Biostatistics, PAREXEL International , Durham , North Carolina , USA.

Abstract

The frailty model is increasingly popular for analyzing multivariate time-to-event data. The most common model is the shared frailty model. Although study design consideration is as important as analysis strategies, sample size determination methodology in studies with multivariate time-to-event data is greatly lacking in the literature. In this article, we develop a sample size determination method for the shared frailty model to investigate the treatment effect on multivariate event times. We analyzed the data using both a parametric model and a piecewise model with unknown baseline hazard, and compare the empirical power with the calculated power. Last, we discuss the formula for testing the treatment effect on recurrent events.

KEYWORDS:

Frailty model; Multivariate survival; Sample size

PMID:
24697252
PMCID:
PMC4024091
DOI:
10.1080/10543406.2014.901346
[Indexed for MEDLINE]
Free PMC Article

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