Simulations for Adaptive Designs in the Regulatory Setting
*Telba Irony, FDA/CDRH Keywords: SImulations, Adaptive Designs, Bayesian Designs In this talk we will discuss the relevance of simulations for designing adaptive clinical trials for regulatory review by the Center for Devices and Radiological Health. Simulations are essential for planning Bayesian clinical studies since no closed formulae are available to assess their operating characteristics particularly for Bayesian adaptive designs. However, I will argue that simulations are also very important even when closed formulae are available because they increase trial predictability helping sponsors prepare for different scenarios, for surprises, and for the costs of the studies.
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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