Trial Simulation for Adaptive Designs
*Scott Berry, Berry Consultants Keywords: Clinical Trial Simulation, Adaptive Designs In this talk I will describe how Clinical Trial Simulation is used to refine, iterate, and create efficient, adaptive clinical trial designs. The building of clinical trial simulation software is a critical aspect of this process of creating better trial designs. I will discuss the building of software, procedures for sharing and presenting trial simulation. The use of simulation in the regulatory approval is a critical aspect to creating more innovative trial designs. I describe several topics on regulatory decision making using simulations -- from a regulatory outsider. These topics touch on independent verification of simulations, explorations from regulatory on simulating trials, and accepting simulation results.
|
Key Dates
-
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