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Recommendations for benefit-risk assessment methodologies and visual representations
Diana Hughes1, Ed Waddingham2, Shahrul Mt-Isa2
1Worldwide Safety Strategy, Pfizer, New York, NY, USA.
Pharmacoepidemiology and Drug Safety
|January 23, 2016
Summary
This study demonstrates that structured benefit-risk assessment is feasible for real-world medicines. Practical guidance is provided to improve decision-making and harmonize approaches.
Area of Science:
- Pharmacovigilance and Drug Safety
- Health Technology Assessment
Background:
- Benefit-risk assessment is crucial for drug evaluation.
- Limited practical appraisal of methodologies exists for real-world scenarios.
Purpose of the Study:
- To provide practical recommendations on methodologies and visualizations for benefit-risk assessment.
- To leverage experience from the PROTECT BR case studies.
Main Methods:
- Utilized eight real-world case studies to evaluate benefit-risk assessment methodologies.
- Identified and tested various techniques from existing literature.
Main Results:
- A five-stage pathway (Planning, Evidence Gathering, Analysis, Exploration, Dissemination) was identified.
- Descriptive/quantitative frameworks, metrics, and elicitation techniques were widely applied.
- Visual tools like tree diagrams and effects tables are universally adopted.
Conclusions:
- Formal, structured benefit-risk assessment is practical and enhances transparency.
- This research offers guidance for harmonizing benefit-risk assessment.
- Real-world case studies validated the usefulness of various assessment methodologies.
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