Abstract Details
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Activity Number:
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468
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Type:
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Topic Contributed
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Date/Time:
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Wednesday, August 7, 2013 : 8:30 AM to 10:20 AM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #310411 |
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Title:
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Simulation-Guided Clinical Trial Design: Does It Improve the Final Design?
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Author(s):
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J. Kyle Wathen*+
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Companies:
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Johnson & Johnson
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Keywords:
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Abstract:
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Many important details of a clinical trial are often ignored in order to simplify the statistical design. In this talk I will present a case study of a trial where simulation was used to gain insight into the impact of various adaptations such as 2-stage design vs a single stage design, safety rules for comparing doses based on two correlated outcomes and futility/superiority decisions based on a third outcome. Simulation was also used to investigate the impact of many design considerations as well as statistical modeling. Through the use of simulation several logistical and statistical issues were raised, however, did the simulation improve the final clinical trial design?
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Authors who are presenting talks have a * after their name.
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