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Statistical Analysis for QT Data
*Phillip Dinh, FDA Keywords: Assessment of QT effects has been becoming a routine in the drug development process. However, the design and analysis of QT studies are still facing some challenges. Topics for discussion include: 1) what is the appropriate QT endpoint? 2) how to evaluate assay sensitivity? 3) what designs are appropriate for a QT study where the drug has to be titrated over many days? 4) How to deal with dropout in a QT study? 5) How to reduce variability?
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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
