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Measuring the Subjective Value of Risky and Ambiguous Options using Experimental Economics and Functional MRI Methods

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Published on: September 19, 2012

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 summary is machine-generated.

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.

Keywords:

benefit-risk decision-making drug development pharmacoepidemiology regulation

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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.