Practical Issues in Vaccine Interim Analysis
View Presentation *Robert C. Kohberger, Blair and Company, LLC Keywords: 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?
|
Key Dates
-
April 30 - May 22, 2013
Invited Abstract Submission Open -
June 4, 2013
Online Registration Opens -
August 9 - August 23, 2013
Invited Abstract Editing -
August 23, 2013
Short Course materials due from Instructors -
August 26, 2013
Housing Deadline -
September 9, 2013
Cancellation Deadline and Registration Closes @ 11:59 pm EDT -
September 16 - September 18, 2013
Marriott Wardman Park, Washington, DC