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Activity Number: 336
Type: Contributed
Date/Time: Tuesday, August 5, 2014 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract #312535 View Presentation
Title: Modeling Longitudinal Data to Assess Clinical Efficacy Equivalence in Clinical Trials
Author(s): Bo Jin*+
Companies: Pfizer
Keywords: Biosimilar ; Equivalence ; Longitudinal Data Analysis ; Emax Model ; Hockey-stick Model
Abstract:

In biosimilar late stage clinical trials, the assessment of clinical efficacy equivalence between the biosimilar and the reference products over multiple time-points sometimes is of particular interest. In this presentation, we compare several longitudinal data analysis (LDA) models for the analysis of DAS28, a continuous composite endpoint which is commonly used to measure severity of rheumatoid arthritis. Specifically, longitudinal Emax model, linear hockey-stick (HS) model, longitudinal linear mixed model and robust linear mixed model will be compared under the various simulated true time-response scenarios. The simulations indicated a tradeoff for the Emax model, which had the smallest standard errors and the greatest power, but had the greatest potential at the same time for yielding biased estimates and inflating alpha levels. The traditional linear mixed models and robust linear models can yield unbiased estimates and keep conservative alpha levels, but are less powerful than Emax and HS models. The linear hockey-stick model appeared to be most robust to true response curves and seemed to control alpha levels while still having satisfactory power.


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