Developing, Testing and Documenting Simulation Software
View Presentation *Nitin R Patel, Cytel, Inc and MIT Keywords: Simulation, software development, documentation, regulatory verification My talk will draw on 27 years of experience at Cytel in developing simulation software for statistical analysis and clinical trial design and implementation. I will discuss development and testing processes that have been important in helping us provide reliable computational results in Monte Carlo and Markov Chain Monte Carlo simulations. I will highlight the role of documentation, openness of design and customization in facilitating regulatory verification and sensitivity analysis. I would like to suggest that FDA and Industry collaborate to develop suitably disguised case studies based on actual clinical trials where simulation models were a key part of the trial design. These cases would serve as vehicles for communicating good simulation practice in submissions to the FDA.
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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