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Assessing A Structured, Quantitative Health Outcomes Approach To Drug Risk-Benefit Analysis
Louis P. Garrison, Jr.,
Adrian Towse and
Brian W. Bresnahan
Regulatory authorities make difficult risk-benefit decisions when approving new drugs. Food and Drug Administration (FDA) advisory committees and reviewers must consider a complex body of evidence, including efficacy and safety results of trials, disease epidemiology, potential side effects, and patients’ needs. However, this menu of information is not usually presented in a consistent and integrated framework. The members of an FDA review panel vote with some unobserved, implicit weighting of the evidence. This paper argues that outcomes research tools for modeling long-term health outcomes, measuring health preferences, and establishing the value of additional information could provide a more structured, transparent, and quantitative process of assessing risk-benefit balance.
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J. P. Thompson, K. Noyes, E. R. Dorsey, S. R. Schwid, and R. G. Holloway
Quantitative risk-benefit analysis of natalizumab
Neurology,
July 29, 2008;
71(5):
357 - 364.
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