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Activity Number:
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415
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Type:
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Roundtables
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Date/Time:
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Wednesday, August 6, 2008 : 12:30 PM to 1:50 PM
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Sponsor:
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Section on Statistics in Epidemiology
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| Abstract - #302569 |
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Title:
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Statistical Innovation in Submissions to FDA and Other Regulatory Bodies
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Author(s):
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Diane Fairclough*+
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Companies:
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University of Colorado Denver
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Address:
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2570 S Jackson St., Denver, CO, 80210,
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Keywords:
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Abstract:
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The goal of this roundtable is to discuss strategies that have been/could be successful or unsuccessful for incorporating statistical innovation into applications for drug and device applications to the FDA and other regulatory bodies. For example, one area where there has been considerable methods research is in the handing of missing data. What strategies have been successful in changing the primary data analysis from complete case or change from baseline to last observation, to those that include all available data, or use methods such as joint (shared parameter) models, pattern mixture models, or multiple imputations? Other examples are encouraged.
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- The address information is for the authors that have a + after their name.
- Authors who are presenting talks have a * after their name.
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