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Activity Number:
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228
- Innovative Statistical Designs with Real Life Case Studies for New Paradigms in Oncology Drug Development
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Type:
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Topic Contributed
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Date/Time:
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Monday, July 30, 2018 : 2:00 PM to 3:50 PM
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Sponsor:
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Biopharmaceutical Section
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Abstract #330741
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Presentation
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Title:
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GBM AGILE: a Phase II/III Platform Design with Signature Identification
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Author(s):
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Todd Graves* and Donald A Berry and Jason Connor
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Companies:
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Berry Consultants LLC and Berry Consultants and M.D. Anderson Cancer Center and ConfluenceStat LLC
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Keywords:
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Adaptive clinical trial;
Platform trial;
Predictive probability;
Population enrichment
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Abstract:
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GBM AGILE is a platform trial in glioblastoma multiforme. Its design features therapies that enter and exit the trial at different times, and it combines the inferential tasks of screening new therapies for efficacy, identifying populations who benefit from therapies, and confirming treatment effects. This talk will introduce the GBM AGILE design and discuss some of its features and some of the challenges in its development.
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Authors who are presenting talks have a * after their name.
