allows stakeholders to have a shared understanding of differences in scientific assessment of preferences regarding health outcomes, which can help to determine whether additional data are needed and whether those data will meet thresholds for influencing future regulatory action. Decision conferencing and MCDA, however, may not be appropriate for every situation, and benefit–risk assessments should be scalable to the severity and scope of the particular public health concern at issue, the level of controversy surrounding it, and FDA resource constraints.
CHMP (Committee for Medical Products for Human Use). 2008. Reflection paper on benefit-risk assessment methods in the context of the evaluation of marketing authorisation applications of medicinal products for human use. London, UK: European Medicines Agency.
Coplan, P. M., R. A. Noel, B. S. Levitan, J. Ferguson, and F. Mussen. 2011. Development of a framework for enhancing the transparency, reproducibility and communication of the benefit-risk balance of medicines. Clinical Pharmacology & Therapeutics 89(2):312-315.
Guo, J. J., S. Pandey, J. Doyle, B. Bian, Y. Lis, and D. W. Raisch. 2010. A review of quantitative risk-benefit methodologies for assessing drug safety and efficacy-report of the ISPOR risk-benefit management working group. Value Health 13(5):657-666.
Linkov, I., and T. P. Seager. 2011. Coupling multi-criteria decision analysis, life-cycle assessment, and risk assessment for emerging threats. Environmental Science and Technology 45(12):5068-5074.
McCaughan, M. 2011. FDA rethinking weight loss standards: A test case for patient-focused drug development. “The Pink Sheet” Daily, June 6, 2011.
NRC (National Research Council). 1994. Science and judgment in risk assessment. Washington, DC: National Academy Press.
NRC. 2009. Science and decisions: Advancing risk assessment. Washington, DC: The National Academies Press.
Phillips, L. D. 2006. Decision conferencing. Operational research working papers, LSEOR 06.85. London, UK: Operational Research Group, Department of Management, London School of Economics and Political Science.
Walker, S., L. Phillips, and M. Cone. 2005 (unpublished). Benefit-risk assessment model for medicines: Developing a structured approach to decision making.