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Abstract Details
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Activity Number:
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240
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Type:
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Contributed
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Date/Time:
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Monday, August 1, 2011 : 2:00 PM to 3:50 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #303390 |
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Title:
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Handling Hierarchical Data Structure in the Safety Evaluation
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Author(s):
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Huanyu Chen*+
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Companies:
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U.S. Food and Drug Administration
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Address:
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10903 New Hanpshire Ave , Silver Spring , MD, 20993,
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Keywords:
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Hierarchical ;
Safety Evaluation ;
Meta analysis ;
Multilevel model
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Abstract:
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Hierarchical data structure is common in the safety data. For example, patient nested within site, site nested within trial, and trial nested within drug, drug nested within drug class. To avoid publication bias using Meta analysis and adjust detailed knowledge of natural history of adverse event in the safe review, we applied multilevel models on pooled safety dataset to detect whether a class of drug is associated with increased risk of 30 day post treatment all cause mortality.
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