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Activity Number: 350
Type: Contributed
Date/Time: Tuesday, August 5, 2014 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract #313051
Title: Efficacy Analyses with an Application in Vaccine Studies with Stratified Design
Author(s): Shu-Chih Su*+ and Frank Liu
Companies: Merck and Merck
Keywords: Efficacy ; Cox regression
Abstract:

There are several different methods for analyzing primary efficacy endpoints in vaccine clinical trials such as Cox regression model and exact method etc. With a stratified study design, those methods will be implemented accounting stratification factors. In such setting, study is usually powered assuming same efficacy effect across randomization stratification such as age, gender or underlying condition subcategories etc. In a recent work, it is found that with potential heterogeneity of the efficacy profile across stratifications which might lead to non-comparable vaccine efficacy. The purpose of this work is to further investigate and validate the performance of the existing approaches. Simulations would be conducted to evaluate the performance in terms of type I error and power by varying the degree of heterogeneity across strata.


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