Model-based benefit-risk assessment: can Archimedes help?

In December 2008, the US Food and Drug Administration issued a new draft Guidance for Industry on Diabetes Mellitus--evaluating cardiovascular risk in new antidiabetic therapies to treat Type 2 diabetes. This guidance comes at a time when recent discussions have focused on delineation of cardiovascular risk reduction for new antidiabetic drugs. Computational tools that can enable early prediction of cardiovascular risk are reviewed with specific reference to Archimedes (Kaiser Permanente), with an aim of proposing a model-based solution and enabling decisions to be made as early as possible in the drug development value chain.