TL1: Logistics and Implementation of Adaptive Trial Designs
*Eva R Miller, inVentiv Health Clinical Keywords: adaptive designs It has been over 5 years since February 2010 and the release of the FDA Draft Guidance for Industry: Adaptive Design Clinical Trials for Drugs and Biologics. Statisticians who would like to share some of their experiences in implementing these adaptive clinical trials and working with their study teams to adopt these new methodologies will discuss their experiences and the differences between adaptive trial designs and the more traditional trials. Impact on teams and team structures will also be discussed. Newcomers to adaptive trial design are welcome. Questions to be covered include but are not limited to: (1) What additional planning, teamwork, software and communication is required for successful implementation of adaptive trial designs? (2) How do simulations play a role in the development of effective adaptive trial designs? (3) What is required for randomization schemes, drug supply management, clean data, and DMCs within adaptively designed studies?
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Key Dates
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June 3, 2014 - September 7, 2015
Online Registration -
June 3, 2015 - August 15, 2015
Housing -
July 31 - August 17, 2015
Invited Abstract Editing -
August 10, 2015
Short Course materials due from Instructors -
August 26, 2015
Advanced Registration Deadline -
September 7, 2015
Cancellation Deadline -
September 16 - 18, 2015
Marriott Wardman Park, Washington, DC