Event Details

For the next in our Distinguished Seminar Series, Prof Deborah Ashby from the School of Public Health at Imperial College London will be giving a talk on "Better benefit-risk decision-making in the regulation of medicines: new opportunities for statistical and data sciences".

For the next in our Distinguished Seminar Series, Prof Deborah Ashby from the School of Public Health at Imperial College London will be giving a talk on "Better benefit-risk decision-making in the regulation of medicines: new opportunities for statistical and data sciences".

Until recently, assessment of the benefit risk balance for a medicine has been entirely informal, but there is now growing interest among drug regulators and pharmaceutical companies in the possibilities of more formal approaches to benefit-risk decision-making, including those which explicitly take patient perspectives into account. Pharmacoepidemiological Research on Outcomes of Therapeutics by a European Consortium (PROTECT) was a project funded under the Innovative Medicines Initiative as a collaboration between academic, pharmaceutical, regulatory and patient organisations. Based on work from PROTECT we review current methodological approaches, and illustrate them with the case-studies where benefit-risk is finely balanced. We will introduce the PROTECT Benefit-Risk Roadmap, designed to help those wishing to find their way through this evolving arena (http://protectbenefitrisk.eu/), and highlight recent statistical developments and current challenges.

Please let Amanda Fenwick know if you are planning on coming along.