TL14: Statistical issues in companion diagnositcs
*Rong Tang, FDA Keywords: A companion diagnostic test may be used to identify patients with certain biological traits and guide optimized therapies to these patients. There is a great deal of interest in developing companion diagnostics for therapies to improve efficacy and minimize harmful side effects. There are many statistical issues associated with companion diagnositics including the exploratory analyses methods in the earlier phases of trials to establish the discriminative cutpoint and clinical trial design to validate the companion diagnostic test as a patient selection device for the therapy. The solutions to these problems depend on whether the test is simultaneously under development with the therapy or an established test, whether the test is a lab developed test or a market ready test. The roundtable provides a platform to discuss the various issues associated with companion diagnostics.
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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