A Seamless 2/3 Design Incorporating a Clinical Utility Index
View Presentation *Zachary Kulkarni Skrivanek, Eli Lilly & Companay Keywords: adaptive design, clinical utility index, dose-finding, seamless phase 2/3 design, Bayesian decision analytic, inferentially seamless We will discuss the design of a novel adaptive, inferentially seamless phase 2/3 study for an experimental drug to treat diabetes. The design employs a Bayesian Analytical approach to allocate patients to a set of doses of the experimental drug and to determine if there are 1-2 doses that could be continued to be studied for the purposes of "confirming" safety and efficacy of those doses. The preference for a dose is determined by a Clinical Utility Index, which balances the select efficacy and safety measures. The algorithm is completely pre-specified and the operating characteristics were assessed via simulation. This design was developed through iterative simulations that involved key decision makers who would normally have input as to what doses were to be selected for confirmatory trials. It involved much more apriori planning than would be required for a typical fixed design.
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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