Trial Design Challenges in Next Generation Drug-Eluting Stents
View Presentation *Peggy J Pereda, Boston Scientific Corporation Keywords: medical device, study design, regulatory submission, trial design, DES Drug-eluting stents (DES) were first approved in the US in 2003 based on randomized controlled trials comparing DES to bare metal stents. Since approval of the first generation DES, the strategy for showing safety and efficacy of a new DES has changed and concerns about potential late safety events have surfaced. Therefore, the requirements for approval of a new DES have changed. One company’s experience with designing trials for a first, second and third generation DES, including the choice of endpoints, sample size calculations and interaction with FDA statisticians, will be discussed.
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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