Drug-Diagnostic Co-Development: Statistical Issues for Companion Diagnostic
View Presentation *Lakshmi Vishnuvajjala, U.S. Food and Drug Administration Keywords: Co-Development, Companion Diagnostic, Study Design With the increase in the number of drugs that are used in conjunction with a diagnostic test, the study designs for co-development are extremely important. Issues for study design are sometimes complicated by the fact that the drugs and diagnostics are developed by different sponsors and a design that can demonstrate that the drug is efficacious cannot necessarily show that the diagnostic is effective.
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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
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September 9, 2013
Cancellation Deadline and Registration Closes @ 11:59 pm EDT -
September 16 - September 18, 2013
Marriott Wardman Park, Washington, DC