Practical Issues in Vaccine Interim Analysis
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*Robert C. Kohberger, Blair and Company, LLC 


Vaccine clinical trials typically involve a large number of subjects with lengthy (> 1 year) follow-up. These characteristics have implications for the design and analysis of interim decisions during the trial. Topics to be examined are: (a) what needs to be tested at the interim when the final analysis includes the concept of “super efficacy”, (b) what are the real cost savings if a trial is stopped early, (c) what information about vaccine efficacy and safety is lost with an early stop, and (d) what does “stop” really means?