Practical Application of Modeling and Simulation in Clinical Trials

Abstract

The human body is a dynamic system that internally regulates energy metabolism and organ energy flux based on environmental inputs (e.g. nutrient availability and palatability and hence intake, temperature, stress, et cetera) and internal control systems. The gut microbiota plays an important role in the digestion and host uptake of nutrients. When attempting to modulate these systems with nutritional and / or pharmacologic interventions these aforementioned inputs and control systems can be modeled to maximize the efficiency of clinical studies designed to quantify the effects. We provide an overview of the components of the approach to design and execute clinical trials and how the application of dynamical systems modeling to human clinical trials of obesity pharmacotherapy improves the outcomes.