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Provide practical recommendations for selecting and applying methodologies and visual representations in benefit-risk assessments using real-world pharmaceutical case studies.

January 22, 2016Pharmacoepidemiology and Drug SafetyOpen Access

Recommendations for benefit–risk assessment methodologies and visual representations

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Provide practical recommendations for selecting and applying methodologies and visual representations in benefit-risk assessments using real-world pharmaceutical case studies.
Tested diverse literature-identified benefit-risk methodologies and visual tools across eight case studies evaluating the benefit-risk balance of real medicines within the PROTECT project.
Synthesized findings across case study outcomes to establish standardized, step-by-step assessment recommendations.
Every assessment followed a consistent five-stage pathway: planning, evidence gathering and data preparation, analysis, exploration, and conclusion and dissemination.
Descriptive and quantitative frameworks effectively structured problems, with metrics, estimation, and elicitation methods incorporating technical data, while tree diagrams and effects tables were universally adopted.

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Implication

Methodological evaluation demonstrates structured frameworks and visual tools standardize benefit-risk assessment in real-world medicines, highlighting practical pathways for transparent decisions.

Cite This Study

Hughes et al. (2016) studied this question.

synapsesocial.com/papers/6a83a5d9d65172829ee6543d https://doi.org/10.1002/pds.3958

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Implication

Methodological evaluation demonstrates structured frameworks and visual tools standardize benefit-risk assessment in real-world medicines, highlighting practical pathways for transparent decisions.

Recommendations for benefit–risk assessment methodologies and visual representations

Key Points

Discussion

Implication

Cite This Study

Recommendations for benefit–risk assessment methodologies and visual representations

Key Points

Discussion

Implication

Cite This Study

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