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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 - #301770 |
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Title:
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Design and Operational Issues in Clinical Trials with Adaptive Design
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Author(s):
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Gang Chen*+
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Companies:
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Johnson & Johnson Pharmaceutical R&D, LLC
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Address:
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920 Route 202, Raritan, NJ, 08502,
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Keywords:
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adaptive design ;
clinical trial ;
type I error
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Abstract:
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The use of adaptive design in clinical trials is often attractive to pharmaceutical industry because this type of design may be more efficient in collecting information and may increase the likelihood of success. However, there are two major issues in such a design and trial conduct: 1) how do we avoid potential "bias" due to the operation; 2) How do we control "type I error" since some factor may not be completely "pre-specified". In this talk both issues will be discussed and an example (trial design) will be given to illustrate those issues.
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Authors who are presenting talks have a * after their name.
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