Conference Proceedings
Clinical Pharmacology & Therapeutics (2009); 85, 3, 241–246 doi:10.1038/clpt.2008.277
Measuring Benefit and Balancing Risk: Strategies for the Benefit–Risk Assessment of New Medicines in a Risk-Averse Environment
—CMR International Institute for Regulatory Science Workshop on Measuring Benefit and Balancing Risk 19–20 June 2008 Washington, DC
S Walker1, N McAuslane1, L Liberti1 and S Salek2
- 1CMR International Institute for Regulatory Science, London, UK
- 2Centre for Socioeconomic Research, Welsh School of Pharmacy, Cardiff, UK
Correspondence: N McAuslane, (nmcauslane@cmr.org)
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Abstract
Measuring the benefits and risks of medicines is the underlying theme whenever the development, review, and regulation of new medicines are discussed. Workshop participants were asked to take the first steps toward defining a framework for benefit–risk (BR) assessment. The framework identifies the essential elements that both regulators and companies should consider throughout the development, review, and postmarketing experience of new medicines in order to apply a consistent approach toward the assessment of BR balance.
