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Activity Number:
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154
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Type:
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Contributed
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Date/Time:
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Monday, July 30, 2007 : 10:30 AM to 12:20 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #309973 |
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Title:
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A Study on Bayesian Signaling of a Prespecified Drug-Adverse Event Association in Post-Marketing Safety Studies
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Author(s):
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Yu-te Wu*+ and George Rochester and Yi Tsong
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Companies:
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Food and Drug Administration and Food and Drug Administration and Food and Drug Administration
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Address:
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10903 New Hampshire Ave, Silver Spring, MD, 20993,
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Keywords:
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Post-marketing safety ; Bayesian method ; Rare adverse event ; Epidemiology
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Abstract:
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Post-marketing safety studies are increasingly used to monitor the potential risk of specific drug-induced adverse events (AEs) and to resolve uncertainties not addressed in new drug applications. Currently popular study designs include active surveillance studies, epidemiologic studies and registries. These studies are primarily designed using the frequentist approach, which may require a prohibitively large sample size and does not allow for continuous monitoring. A Bayesian design may allow for earlier detection of the safety signal because of its flexibility in continuous monitoring. In this presentation, we will apply the Bayesian approach to the monitoring and detection of rare AEs in post-marketing epidemiologic safety studies to investigate the feasibility of the Bayesian design, and also evaluate how it performs compared to conventional approaches.
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