FDA Grand Rounds: How Simulation Can Transform Regulatory Pathways

FDA recognizes the public health benefits offered by modeling and simulation, including those in the area of in silico clinical trials (using individualized computer simulation in development and or regulatory evaluation of medical products, medical device, or medical interventions).

FDA advocates for their use as one of many research and product development tools because modeling and simulation play a critical role in, among other areas, organizing diverse data sets, exploring alternate study design strategies, and predicting performance, so that safe and effective new therapeutics can advance more efficiently, from preclinical studies through clinical trials to market.

FDA routinely advises industry on using modeling and simulation to, for example : 1) predict clinical outcomes, 2) inform clinical trial designs, 3) support evidence of effectiveness, 4) identify the most relevant patients to study, and 5) predict product safety. In some cases, in silico clinical trials are used to replace human clinical trials, especially those that are intended to evaluate the risk of drug interactions. FDA will continue to advance these methodologies and techniques to ensure the benefits of product innovation and more rapid introduction of life-saving technology to our nation’s patients.

This presentation will provide an overview of those methodologies, highlight success stories with simulation, and discuss the potential for in silico clinical trials for advancing medical products.