Risk Mitigation Strategies in Design and Implementation of Adaptive Designs
*Brenda Gaydos, Eli Lilly and Company Keywords: Adaptive Designs The trial implementation strategy is a key consideration in the design of an adaptive trial. It is necessary to first understand operational constraints within a particular development program prior to proposing trial design alternatives for investigation. In addition, as part of the planning process, the likelihood of a successful trial (i.e. a trial that answers the research question) increases if mitigation strategies are put in place a priori for potential implementation issues. In this presentation, completed case studies utilizing sample size re-estimation, response adaptive randomization and seamless 2/3 treatment selection will be used to illustrate approaches taken to build in safeguards. The DMC constructs utilized will also 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