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Thursday 10 Dec 2015Statistical Science Seminar: What role should formal risk-benefit decision-making play in the regulation of medicines?

Deborah Ashby - Imperial College

H101 14:30-16:30

For a medicine to gain a license it requires evidence of its efficacy and safety. Study designs and statistical methods are well-developed to deal with the former and to a lesser extent the latter. However, until recently, assessment of the benefit risk balance for a medicine especially in relation to alternatives has been entirely informal. There is now growing interest among drug regulators and pharmaceutical companies in the possibilities of more formal approaches to benefit-risk decision-making.  One such initiative forms part of the Pharmacoepidemiological Research on Outcomes of Therapeutics by a European Consortium (PROTECT) project, which is funded under the Innovative Medicines Initiative and is a collaboration between academic, pharmaceutical, regulatory and patient organizations. Based on work from this project we will review current methodological approaches, and illustrate them with case-studies on medicines where benefit-risk is finely balanced. We will introduce the PROTECT Benefit-Risk Roadmap which is designed to help those wishing to find their way through this evolving arena.

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