Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research
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The Food and Drug Administration, currently, is exploring quantitative benefit-risk methods to support regulatory decision-making. A scientifically valid method for assessing patients' benefit-risk trade-off preferences is needed to compare risks and benefits in a common metric. ⋯ Variation in MARs across AE types is consistent with the relative seriousness of the AEs. Stated-preference methods offer a scientifically valid approach to quantifying benefit-risk trade-off preferences that can be used to inform regulatory decision-making.