This is the program for the 2010 Joint Statistical Meetings in Vancouver, British Columbia.
Abstract Details
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Activity Number:
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4
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Type:
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Invited
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Date/Time:
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Sunday, August 1, 2010 : 2:00 PM to 3:50 PM
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Sponsor:
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SPAIG Committee
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| Abstract - #306272 |
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Title:
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Partnership in New Drug Developments
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Author(s):
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Ji Zhang*+ and Hui Quan and Alex Boddy and Peng-Liang Zhao and Stan Young
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Companies:
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Sanofi-Aventis and sanofi-aventis and sanofi-aventis and sanofi-aventis and National Institute for Statistical Science
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Address:
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BX2-600H, 200 Crossing Blvd, Bridgewater, NJ, 08807,
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Keywords:
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adaptive design ;
missing data ;
TQT trials ;
DMC
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Abstract:
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New drug development is a highly regulated and complex process. There are many issues in trial design and data analysis of concern and interest to both industry and FDA statisticians. Academic statisticians thus can play an active role to link both sides and bridge the gap in tackling these issues, particularly to accelerate the application of new theoretical results to clinical trials. The current landscapes on the applications of adaptive design and missing data handling will be used to illustrate the situations. Recent development example on the effort of searching more efficient ways for TQT trial design and data analysis will be presented. In addition the industry is facing challenges in finding DMC independent statisticians. A model of joining force with NIH and other associations for training the next generation of DMC statisticians will be discussed.
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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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