Bayesian approaches to the value of information: Implications for the regulation of new pharmaceutical

The current regulation of new pharmaceuticals is inefficient because it dem ands arbitrary amounts of information, the type of information demanded is not relevant to decision-makers and the same standards of evidence are appl ied across different technologies. Bayesian decision theory and an analysis of the value of both perfect and sample information is used to consider th e efficient regulation of new pharmaceuticals. This type of analysis can be used to decide whether the evidence in an economic study provides 'suffici ent substantiation' for an economic claim, and assesses whether evidence ca n be regarded as 'competent and reliable'. Copyright (C) 1999 John Wiley & Sons, Ltd.