Kenward-Roger Adjustment's Application in Multicenter Clinical Trial Study
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*Judy X. Li, FDA 

Keywords: Kenward-Roger, Multi-site Clinical Trial, Sample Size

Kenward-Roger (KR) adjustment is well known for small sample size mixed effects model. The talk is going to focus on the application of KR method for multicenter clinical trial study, where both the number of centers and the number of patients within each center affect the estimation precision of the treatment effect. Simulation studies are conducted to illustrate the application of KR adjustment under difference scenarios, and comparisons are made with the unadjusted test.