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Activity Number:
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273
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Type:
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Topic Contributed
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Date/Time:
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Tuesday, July 31, 2007 : 10:30 AM to 12:20 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #309493 |
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Title:
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One Adaptive Design and Its Application to Medical Device PMA Study
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Author(s):
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Xiaolong Luo*+ and David Snead and Dennis Donohoe
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Companies:
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Johnson & Johnson PRD and Cordis, a Johnson & Johnson Company and Cordis, a Johnson & Johnson Company
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Address:
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45 Technology Dr, Warren, NJ, 07059,
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Keywords:
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adaptive design ; medical device ; noninferority ; spending function
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Abstract:
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Adaptive clinical trial design and analysis have been intensively studied and evaluated for pharmaceutical drug development during the past several years. It has the potential to shorten the study duration and minimize the patient resource. At the same time, it presents unique challenge to clinical operations and appropriateness of statistical analysis. There is additional challenge in its application in medical device area where double blind randomized control study may not be feasible in many situations. However, the need for optimizing trial design to better protect patients and to expedite the therapeutic options to medical community is equally important. In this talk, we will discuss some general concepts in adaptive design.
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