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Abstract Details
Activity Number:
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231
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Type:
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Topic Contributed
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Date/Time:
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Monday, July 30, 2012 : 2:00 PM to 3:50 PM
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Sponsor:
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Biopharmaceutical Section
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Abstract - #305772 |
Title:
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Applications of Adaptive Designs in Clinical Trials
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Author(s):
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Henry S Hsu*+ and Min Annie Lin
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Companies:
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FDA/CBER and FDA/CBER
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Address:
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1401 Rockville Pike, HFM-210, Rockville, MD, 20852,
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Keywords:
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adaptive designs ;
regulatory perspective ;
biologics
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Abstract:
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Speaker: Henry S. Hsu*, Ph.D., MPH; henry.hsu@fda.hhs.gov Annie Lin, Ph.D.; min.lin@fda.hhs.gov
Title: Regulatory Perspective on Adaptive Design Clinical Trials for Biologics
Since FDA has released the draft guidance on Adaptive Design Clinical Trials for Drugs and Biologics in early 2010, there are many articles and forums that discuss the proposed procedures and related issues. FDA/CBER also received an increase in adaptive design protocols in clinical trials submitted by the sponsors. In this talk, an overview of this guidance from regulatory perspective and safety consideration on biologics will be presented to include description, motivation, and general concerns on adaptive designs. Also will be presented are those generally well-understood and less regulatory experience adaptive designs with valid approaches to implementation. Finally we will provide a brief summary of proposed adaptive designs for biologics in CBER and discuss the statistical issues raised by the regulatory reviews.
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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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