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Activity Number:
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51
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Type:
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Topic Contributed
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Date/Time:
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Sunday, July 29, 2007 : 4:00 PM to 5:50 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #309458 |
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Title:
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The Application of Adaptive Design in R&D in Japan from a Statistical Point of View
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Author(s):
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Hajime Uno and Yoko Tanaka*+ and Masahiro Takeuchi and Fumiaki Takahashi
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Companies:
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Eli Lilly and Company and Kitasato University and Kitasato University and Kitasato University
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Address:
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Corporate Center, Indianapolis, IN, 46285,
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Keywords:
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global trial ; bridging study
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Abstract:
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The U.S. 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. Recently, the concept of the E5 guideline has been extended to a simultaneous global study through mutual extrapolation of clinical data among regions. We investigate the application of adaptive design in R&D in Japan and discuss the associated statistical issues related to usage of surrogate markers, sample size re-calculation and the definition of similarity of drug efficacy.
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