Assessing a structured, quantitative health outcomes approach to drug risk-benefit analysis.
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.
Garrison
Louis P
LP
Department of Pharmacy, University of Washington, Seattle, USA. lgarrisn@u.washington.edu
Towse
Adrian
A
Bresnahan
Brian W
BW
D017277:Drug Approval / Q000379:methods*; D004345:Drug Industry; D019317:Evidence-Based Medicine / Q000379:methods; D006801:Humans; D008962:Models, Theoretical; D017063:Outcome Assessment, Health Care / Q000379:methods*; D019057:Quality-Adjusted Life Years; D018570:Risk Assessment / Q000379:methods; D014481:United States; D014486:United States Food and Drug Administration