TL7: Adaptive Designs in Medical Device Studies
*Jie Zhou, FDA Keywords: adaptive design, operational bias, medical device Clinical studies with adaptive designs have been gaining attention from the medical device industry. The flexibility of these designs makes them quite popular. However, the challenges associated with these designs include unfamiliarity of the relevant statistical methodologies, the cost of extensive upfront planning, the operational/logistical issues involved and the acceptance of regulatory authorities. Please come and discuss the theoretical and practical issues you faced in adaptive designs and share some examples with your colleagues.
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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