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Activity Number:
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270
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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 - #309840 |
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Title:
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Adaptation of Adaptive Design in Japan
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Author(s):
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Masahiro Takeuchi*+ and Hajime Uno and Fumiaki Takahashi
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Companies:
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Kitasato University and Kitasato University and Kitasato University
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Address:
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5-9-1, Shirokane, Minato-ku, Tokyo, 108-8641, Japan
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Keywords:
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global trial ; bridging study
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Abstract:
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The US Food and Drug Administration published "Challenge and Opportunity on the Critical Path to New Medical Products" in 2004 in order to stimulate an innovative approach to the research and development of new medical products. It is well recognized that the excellent progress of basic science has discovered potential products, but that the slow progress of applied science has failed to deliver them to patients in a timely fashion. Therefore the concept of an adaptive design has been investigated extensively. The situation in Japan is very similar to the USA. Recently, the concept of the E5 guideline has been extended to a simultaneous global study through mutual extrapolation of clinical data among regions. We briefly overview the Japanese situation from perspectives of a clinical trial design and discuss the associated statistical issues.
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