Abstract:
:Competing risks data often exist within a center in multi-center randomized clinical trials where the treatment effects or baseline risks may vary among centers. In this paper, we propose a subdistribution hazard regression model with multivariate frailty to investigate heterogeneity in treatment effects among centers from multi-center clinical trials. For inference, we develop a hierarchical likelihood (or h-likelihood) method, which obviates the need for an intractable integration over the frailty terms. We show that the profile likelihood function derived from the h-likelihood is identical to the partial likelihood, and hence it can be extended to the weighted partial likelihood for the subdistribution hazard frailty models. The proposed method is illustrated with a dataset from a multi-center clinical trial on breast cancer as well as with a simulation study. We also demonstrate how to present heterogeneity in treatment effects among centers by using a confidence interval for the frailty for each individual center and how to perform a statistical test for such heterogeneity using a restricted h-likelihood.
journal_name
Stat Methods Med Resjournal_title
Statistical methods in medical researchauthors
Ha ID,Christian NJ,Jeong JH,Park J,Lee Ydoi
10.1177/0962280214526193subject
Has Abstractpub_date
2016-12-01 00:00:00pages
2488-2505issue
6eissn
0962-2802issn
1477-0334pii
0962280214526193journal_volume
25pub_type
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