Statistics Seminars: What role should formal risk-benefit decision-making play in the regulation of medicines?
16 February 2012 16:30 in CM221
The regulation of medicine requires evidence of the efficacy and safety of medicines, and methods are well-developed to deal with the latter and to a lesser extent the former. However, until recently, assessment of risk-benefit especially in relation to alternatives has been entirely informal. There is now growing interest in the possibilities of more formal approaches to risk-benefit decision-making. In this talk, we review the basis of drug regulation, the statistical basis for decision-making under uncertainty, current initiatives in the area, and discuss possible approaches that could enhance the quality of regulatory decision-making.
Contact I.R.Vernon@durham.ac.uk for more information