Statistical Issues in Survival Analysis for the Clinical Validation of Diagnostic Devices
*Yuying Jin, CDRH/FDA Meijuan Li, CDRH/FDA Keywords: Diagnostic Device, Survival analysis, competing risk, cured rate, risk prediction, time-event data, Baysian It becomes more common that clinical validation study for certain diagnostic devices involves time-event data. While survival analysis is always an interesting topic in statistics, new issues faced in time to event data analysis of risk prediction and companion diagnostic devices is practically challenging. How to address the time dimension and censoring has been an active research area in diagnostic medicine. In this talk, we are going to explore some recent advance and challenges and issues of survival analysis such as competing risks, cure rate in risk predication and companion diagnostic devices of personalized medicine. In our presentation, we will discuss the definition and statistical issues of competing risk and “cured”patients. We will also propose a statistical method in addressing competing risk and cured rate using Baysian approach. Simulations and examples will be presented to illustrate our method.
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Key Dates
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November 1 - December 17, 2013
Online proposal submission for a session, short course and Town Hall Open -
January 6 - March 11, 2014
Online proposal submission for Roundtables Open -
April 30 - May 28, 2014
Abstract Submission Open -
June 4, 2014
Online Registration Opens -
August 8 - August 22, 2014
Invited Abstract Editing -
August 11, 2014
Short Course materials due from Instructors -
September 1, 2014
Housing Deadline -
September 15, 2014
Cancellation Deadline and Registration Closes @ 11:59 pm EDT -
September 22 - September 24, 2014
Marriott Wardman Park, Washington, DC