Statistical Challenges in Vaccine Clinical Studies: An FDA Perspective
*Amelia Dale Horne, FDA-CBER Keywords: Vaccine, Safety, Efficacy, Immunogenicity This presentation will summarize some of the major statistical issues the FDA must consider in the overall evaluation of preventive vaccines. These issues relate to study design, conduct, and analysis. Ultimately, the FDA must make regulatory decisions regarding licensure and label indications with respect to efficacy, immunogenicity, and safety of the vaccines that are under review. Current issues of interest in evaluating these vaccines will be discussed.
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Key Dates
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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