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little regulatory experience with these studies and their properties were not fully understood at the time of draft guidance release.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.