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Activity Number:
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409
- Complex Innovative Approaches in Emerging Neurodegenerative / Neuroimaging Drug Developments
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Type:
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Topic Contributed
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Date/Time:
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Wednesday, August 5, 2020 : 1:00 PM to 2:50 PM
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Sponsor:
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Biopharmaceutical Section
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Abstract #313524
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Title:
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Statistical Issues and Challenges Seen in Drug Development for Neurodegenerative Diseases
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Author(s):
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Tristan Massie*
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Companies:
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FDA
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Keywords:
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estimand;
intercurrent events
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Abstract:
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A senior FDA statistical reviewer's perspective on some of the common statistical challenges arising in Neurology clinical trials. Common major issues are how to handle potentially biasing intercurrent events such as death or starting of other active treatments, the impact of missing data in general, and special considerations for interim analyses with a continuous longitudinal outcome measure. Examples and simulation results will be provided to illustrate the shortcomings of some methods seen in practice and potential alternatives.
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Authors who are presenting talks have a * after their name.
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