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Activity Number: 232
Type: Topic Contributed
Date/Time: Monday, August 10, 2015 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract #314738 View Presentation
Title: 'Promising Zone' Design Case Studies
Author(s): Zoran Antonijevic*
Companies:
Keywords: sample size re-assessment ; promising zone ; design ; regulatory interactions ; implementation
Abstract:

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size re-assessment (ubSSR) has been categorized as a "less-well understood" type of adaptive design in the CDER/CBER draft guidance on adaptive design.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.


Authors who are presenting talks have a * after their name.

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