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Activity Number:
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296
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Type:
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Luncheons
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Date/Time:
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Tuesday, August 8, 2006 : 12:30 PM to 1:50 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #306375 |
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Title:
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On the Evaluation of Benefit and Risk: the Tools We Have and How They Help
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Author(s):
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Yili Pritchett*+
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Companies:
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Abbott Laboratories
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Address:
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100 Abbott Park Road, Abbott Park, IL, 60064-6116,
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Keywords:
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benefit-risk evaluation ; clinical trials ; new drug development
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Abstract:
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The need for quantitative tools to evaluate the benefit-risk profile of a treatment has been recognized and discussed in recent years. Some methodologies (e.g., NNT/NNH, Global Benefit-Risk) have been proposed and applied to real data from clinical trials. PhRMA and FDA have had serious discussions on this topic. What about the day-to-day practice of biostatisticians in industry? Do biostatisticians use certain models and conduct this type of analysis before or after the registration? Do those analyses provide new perspective to the understanding of a therapy? Do those approaches add value to the course of drug development?
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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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