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Benefit-risk analysis : a brief review and proposed quantitative approaches
1Aventis Pharmacueticals, Bridgewater, New Jersey 08807-0890, USA. william.holden@aventis.com
Drug Safety
|September 10, 2003
Summary
Quantitative methods like relative-value adjusted number-needed-to-treat (RV-NNT) and minimum clinical efficacy (MCE) analysis offer objective drug benefit-risk assessment. These approaches incorporate patient preferences for better clinical and regulatory decision-making.
Area of Science:
- Pharmacology
- Health Economics
- Biostatistics
Background:
- Benefit-risk analysis is predominantly qualitative.
- Objective drug evaluation requires quantitative methods.
Purpose of the Study:
- To propose quantitative methods for drug benefit-risk synthesis.
- To enhance objectivity in evaluating drug efficacy and safety.
Main Methods:
- Relative-value adjusted number-needed-to-treat (RV-NNT) analysis.
- Minimum clinical efficacy (MCE) analysis.
- Incorporation of patient utility data for outcomes and adverse events.
Main Results:
- Hypothetical rheumatoid arthritis drug data demonstrated quantitative distinctions.
- RV-NNT analysis indicates patient willingness to accept risks for benefits.
- MCE analysis quantifies treatment worth considering disease risk.
Conclusions:
- Quantitative benefit-risk methods improve drug evaluation.
- These methods support informed decisions by clinicians, regulators, and patients.
- Patient-centered perspectives are crucial in pharmacovigilance.