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Abstract Details
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Activity Number:
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130
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Type:
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Contributed
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Date/Time:
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Monday, August 1, 2011 : 8:30 AM to 10:20 AM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #303355 |
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Title:
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Simulation and Optimization of an Adaptive Phase II Dose-Finding Study
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Author(s):
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Yannis Jemiai*+
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Companies:
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Cytel Inc.
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Address:
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, Cambridge, MA, 02139, USA
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Keywords:
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adaptive ;
dose-finding ;
phase 2 ;
optimization ;
simulation
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Abstract:
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The proper design of phase 2 studies in drug development is critical in appropriately assessing the safety profile and collecting preliminary evidence of efficacy with which to move forward. A case study on the planning of a response-adaptive dose-finding study in neuropathic pain will be presented, including statistical and operational aspects of the trial design. Consultation with an inter-disciplinary group of professionals allowed an integrated evaluation of the potential implementation hurdles and benefits of the adaptive design. Intense simulation studies were required to produce the necessary evaluations under a variety of possible scenarios and design alternatives. Trial simulation software was particularly critical for the planning exercise.
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Authors who are presenting talks have a * after their name.
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