Abstract Details
Activity Number:
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326
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Type:
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Invited
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Date/Time:
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Tuesday, August 6, 2013 : 10:30 AM to 12:20 PM
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Sponsor:
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Biopharmaceutical Section
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Abstract - #307354 |
Title:
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Leveraging Longitudinal Data in Dose-Finding Studies
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Author(s):
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Chyi-Hung Hsu*+ and Jose Carlos Pinheiro
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Companies:
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Janssen Research & Development and Janssen R&D
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Keywords:
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clinical trials ;
dose finding ;
longitudinal data analysis
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Abstract:
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Incorrect dose selection for confirmatory studies remains one of the key drivers of the high attrition rate observed in late phase drug development. Even though this is a well-known problem in clinical drug development, sponsors are often reluctant to make larger investments in exploratory dose ranging studies, opting, instead, to save resources for costly Phase 3 studies. A possible remedy, or palliative, for this conundrum is the better utilization of clinical data already collected in Phase 2 studies, such as longitudinal measurements on clinical endpoints and biomarkers. This talk will focus on the use of dose-time response models incorporating all available clinical data to improve the efficiency and accuracy and dose selection. A real-data example will used to illustrate the challenges and benefits of the approach.
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Authors who are presenting talks have a * after their name.
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