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Abstract Details
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Activity Number:
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160
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Type:
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Topic Contributed
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Date/Time:
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Monday, August 1, 2011 : 10:30 AM to 12:20 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #301771 |
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Title:
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Evaluating the Usefulness of Adaptive Designs in Practice: Going Beyond Statistical Characteristics
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Author(s):
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Jose Carlos Pinheiro and Chyi-Hung Hsu*+
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Companies:
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Johnson & Johnson Pharmaceutical R&D, LLC and Johnson & Johnson Pharmaceutical R&D, LLC
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Address:
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, , ,
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Keywords:
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adaptive design ;
clinical trial ;
dose-ranging study
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Abstract:
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When evaluating the appropriateness an adaptive design in drug development practice, one needs to take into account not only its statistical operating characteristics, such as power, precision of estimates, and sample size, but also its operational and implementation requirements and potential hurdles, such as drug supply and patient recruitment. In this talk, we use the planning of an adaptive dose-ranging study in a neuro-degenerative indication to motivate and illustrate the different factors that need to be taken into account in the design and evaluation of adaptive designs. A multi-disciplinary group was involved in the planning of the study, which was critical to allow an integrated evaluation of the potential implementation hurdles and benefits of the proposed design.
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The address information is for the authors that have a + after their name.
Authors who are presenting talks have a * after their name.
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