FDA Perspectives on Computer Simulations in the Evaluation of Medical Devices
FDA acknowledges the benefits to public health provided by modeling and simulation, such as those in the developing area of in silico clinical trials; in other words, the use of individualized computer simulation in the development and/or regulatory evaluation of medical products, medical device, or medical interventions (Avicenna Roadmap-2016). FDA advocates for their use as one of many research and product development tools because modeling and simulation play a critical role in organizing diverse data sets, exploring alternate study design strategies, identifying subpopulations for therapy, and in some cases, 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 the use of modeling and simulation to predict clinical outcomes, inform clinical trial designs, support evidence of effectiveness, optimize dosing, identify the most relevant patients to study, predict product safety, and evaluate potential adverse event mechanisms. 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, or where information from a computer-based model can better inform the performance of a medical device as compared to data collection in a human clinical trial. FDA intends to continue advancing these methodologies and techniques from both a science and regulatory perspective to best take advantage of the benefits for continued product innovation and more rapid introduction of life-saving technology to US patients. This presentation will provide an overview of those methodologies and highlight the possibility for in silico clinical trials to be used for evaluating medical products.
March 29, 2018