Statistical Challenges with Emerging Adaptive Designs of Cardiovascular Device Studies: A Case Study and Beyond
*Yun-ling Xu, FDA Ying Yang, FDA Yu Zhao, FDA Keywords: Emerging adaptive design, PMA, Statistical challenge On the changing landscape in cardiovascular device development, new adaptive designs are emerging to meet the advancement in technology and regulation. Within the context of using the result to support a pre-market application (PMA), challenging statistical issues related to emerging adaptive designs, including operating characteristics and practical implementation will be discussed with a case study.
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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