Abstract Details
Activity Number:
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350
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Type:
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Contributed
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Date/Time:
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Tuesday, August 5, 2014 : 10:30 AM to 12:20 PM
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Sponsor:
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Biopharmaceutical Section
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Abstract #313838
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Title:
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Recommendations for the Methodology and Visualization Techniques to Be Used in the Assessment of Benefit and Risk of Medicines: Findings from IMI Protect Consortium
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Author(s):
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Gerald Downey*+ and Diana Hughes
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Companies:
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Amgen and Pfizer
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Keywords:
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Benefit-Risk ;
Quantitative ;
Qualitative ;
Decision-Making ;
Medicines ;
Framework
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Abstract:
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Under the umbrella of the IMI PROTECT consortium, members have advanced the understanding of both the integration and visual representation of benefit and risk data. Following a robust literature review, selected methodologies and visualisation techniques were applied in several case studies. The experieriences of the case study teams has been distilled into a clear set of practical recommendations organised around five stages of a generic benefit-risk assessment roadmap: (1) Planning (2) Evidence Gathering and Data Preparation (3) Analysis (4) Exploration (5) Conclusion and Dissemination While no single benefit-risk methodology can fully capture all aspects of a benefit-risk assessment, the choice of a single approach or combination of methodologies should be matched to the complexity of the problem. Several ongoing initiatives are examining the role of formal benefit-risk assessment methods, and PROTECT's experience makes a unique contribution which complements and builds on other efforts. The recommendations provided should serve as a valuable guide for readers new to the world of benefit-risk assessment as they highlight key issues/considerations that are common to many approaches.
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Authors who are presenting talks have a * after their name.
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