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Wednesday, September 27
Wed, Sep 27, 8:30 AM - 9:45 AM
Thurgood Marshall South
Parallel Session: What Industry and FDA See: How Adaptive Our Clinical Trials Are

DIA Adaptive Designs Scientific Working Group Survey Results (300533)

*Alan H Hartford, AbbVie 

The Drug Information Association (DIA) Adaptive Designs Scientific Working Group (ADSWG) Survey Subteam has summarized four surveys providing information about the perception and use of adaptive designs (ADs) for clinical development programs of drugs and biologics in industry and academia. These four surveys each span a four-year period (2000-2003, 2004-2007, 2008-2011, and 2012-2015) with earlier results being published by Quinlan et al in 2010 and Morgan et al in 2014. These four surveys have a structure of consistent questions for better understanding of the AD usage trends while a group of questions were added in later versions to better understand current circumstances. Responders include both industry and academic institutions. In addition to the first set of surveys, reviews of literature and registry entries over the four-year intervals were also summarized for wider understanding of current and past acceptance of ADs. The design, implementation, and results will be summarized in this presentation.