Addressing Challenges and Opportunities of “Less Well Understood” Adaptive Designs
*Weili He, Merck & Co. Inc. *Paul Gallo, Novartis Keywords: Less-well understood adaptive designs; DIA; ADSWG; The draft adaptive design guidance released by FDA included an overview of adaptive study designs that were termed as less-well understood. There was relatively little regulatory experience with these studies and their properties were not fully understood at the time of draft guidance release. In order to promote greater use of adaptive designs, especially those that were categorized as less-well understood, the DIA ADSWG Best Practice Subteam has worked on describing and characterizing these less-well understood trials, identifying challenges related to these trials, and making suggestions on design or study conduct improvements. This talk will summarize the work from the subteam.
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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