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Abstract Details
Activity Number:
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440
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Type:
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Invited
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Date/Time:
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Wednesday, August 3, 2011 : 8:30 AM to 10:20 AM
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Sponsor:
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Biopharmaceutical Section
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Abstract - #300418 |
Title:
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Supporting Medical Decisionmaking Through Dynamic 3D Visualization of Risk, Benefit, and Uncertainty
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Author(s):
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Richard A. Forshee*+ and Arianna Simonetti and Mark O. Walderhaug and Anne Fernando
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Companies:
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U.S. Food and Drug Administration/CBER and U.S. Food and Drug Administration/CBER and U.S. Food and Drug Administration and Norfolk State University
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Address:
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1401 Rockville Pike, HFM 210, Rockville, 20852,
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Keywords:
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Risk-Benefit assessment ;
visualization ;
medical decision-making ;
biologics ;
vaccine
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Abstract:
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One of the challenges for Risk:Benefit analysis is to develop tools to help decision-makers analyze the risks and benefits of products while properly characterizing the uncertainty of the estimates of risks and benefits. We have developed a three-dimensional visualization tool where the height of the surface represents the probability that the treatment has a particular risk-benefit coordinate. The model is applied to historical data from clinical trials and post-market surveillance for a vaccine that was determined to have an elevated risk for an adverse event. The tool shows key properties of distributions that may affect decision-making; integrates data on multiple properties of a medical product; demonstrates the evolution of scientific knowledge, and encourages stakeholders to interact with the visualization to explore what-if scenarios.
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Authors who are presenting talks have a * after their name.
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