Modeling, Simulation, and the Critical Path

The benefits of modeling and simulation fall into two categories: Increased certainty in trial designs and faster decisions to kill or advance compounds. The first, more tactical benefit means trials are less likely to fail because they are properly powered and optimally designed to address the hypotheses of interest. The second, more strategic benefit of modeling and simulation, faster decisions to kill or advance compounds, aligns directly with FDA’s Critical Path goal to “ensure that basic scientific discoveries translate more rapidly into new and better medical treatments.”