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Bethesda North Marriott Hotel and Conference Center

Mar 18, 2014 8:30 AM - Mar 20, 2014 4:00 PM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Beginning with the End in Mind – Study Endpoints: Targeting Patient-Centered Outcomes

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Adaptive Designs and Endpoint Selection (Via Telecommunications)

Session Chair(s)

Scott Berry, PhD

Scott Berry, PhD

President and Senior Statistical Scientist

Berry Consultants LLC, United States

The selection of endpoints in the learn phases of trials can be a very difficult problem typically involving the time of the trial, the relevance of the endpoint, and the power of the study. Many times decisions to select short term endpoints, for the sake of speed of getting to phase III can create poor dose selection, incorrect go/no-go decisions, and inefficient drug development. The issue can be more complex in an adaptive trial design because of the need to provide information for the adaptations. A strength of the adaptive design is that it can utilize endpoints in different ways -- early markers can be used as possibly correlated to the more appropriate long-term endpoint, and this correlation can be modeled and informed by the trial, and thus the design can be made more efficient and yet the focus is on the more relevant long-term clinical endpoint. In this talk the selection of endpoints, the modeling of different endpoints, within the building and simulation of an adaptive clinical trial will be discussed. Real examples of endpoint selection within adaptive designs will be presented.

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