Points to Consider in Design of Trials for Drug-Diagnostic Co-Development in Oncology
*Michael Wolf, Amgen Keywords: Prospective analysis of a completed or on-going phase 3 oncology drug study to assess device effectiveness in the context of drug-diagnostic co-development. The Vectibix-KRAS experience in colorectal cancer will be used as an example. Also considered will be examples of prospective drug-diagnostic designs either with a clear biomarker hypothesis or when a place-holder is desired for one due to a lag in diagnostic development. A flexible regulatory pathway in these areas will impact the ability to fulfill the promise of personalized medicine.
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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
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August 26, 2013
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September 9, 2013
Cancellation Deadline and Registration Closes @ 11:59 pm EDT -
September 16 - September 18, 2013
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