Chair: Ginger Haynes, PhD

The adaptive design workshop will present a case study illustrating how statisticians and clinicians collectively prepared an argument for using adaptive design in Phase IIB rather than a traditional design. This argument was to be made to senior management who may be very skeptical to accepting or implementing new strategies.  Evidence provided in the case will include relevant upfront costs, overall duration of the trial, sample size differences, overall cost, and as well as potential challenges from regulatory agencies.  This case study is designed to demonstrate the practical value of adaptive design to a non-statistical audience and generate group discussion about additional evidence that would be convincing in a business environment.