RL17 Fixed vs. Mixed Non-Inferiority Margin in the Evaluation of Medical Devices
*Shiowjen Lee, U.S. Food and Drug Administration Keywords: In the evaluation of medical device applications, sponsors sometimes propose mixed non-inferiority margins based on both absolute difference and relative risk. Although the type I error rate may be controlled statistically, it however can result an unacceptable outcome from clinical perspective. Consequently, it comes to the point that the choice of non-inferiority margin at the design stage not only should be statistically sound, but also clinically relevant and acceptable. At this roundtable, we will discuss some issues concerning this topic.
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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