Abstract Details
Activity Number:
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232
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Type:
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Topic Contributed
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Date/Time:
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Monday, August 10, 2015 : 2:00 PM to 3:50 PM
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Sponsor:
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Biopharmaceutical Section
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Abstract #314738
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View Presentation
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Title:
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'Promising Zone' Design Case Studies
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Author(s):
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Zoran Antonijevic*
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Companies:
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Keywords:
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sample size re-assessment ;
promising zone ;
design ;
regulatory interactions ;
implementation
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Abstract:
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The unblinded sample size re-assessment (ubSSR) has been categorized as a "less-well understood" type of adaptive design in the CDER/CBER draft guidance on adaptive design. There has been, however, an increase in application of this type of design since the publication of this guidance. In this talk we will present selected case studies of trials using the uSSR. The presentation will address trial designs, regulatory interactions and operational challenges.
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Authors who are presenting talks have a * after their name.
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