The FDA encourages the use of in silico clinical trials in which a drug or device is tested against a cohort of virtual patients, thereby providing an empirical basis for proper comparative evaluation.
September 01, 2022
In clinical research and development, comparison with a control is strongly recommended by regulatory agencies for the purpose of demonstrating evidence of clinical efficacy of a drug or device. The control could be a placebo, a known standard of care, or a commercially available and approved drug or device. With some diseases or classes of devices, viable control (prospective or retrospective) may not be feasible for ethical or pragmatic reasons. Moreover, this problem is not uncommon in the biotech and medtech industries.
This creates the need for alternative approaches to benchmarking. Computational modeling and simulation (CM&S) has been identified by the United States Food and Drug Administration (FDA) as a necessary component for the development of in silico trial designs, in which the comparator arm is generated at the using CM&S techniques. The FDA encourages the use of in silico clinical trials in which a drug or device is tested against a cohort of virtual patients, thereby providing an empirical basis for proper comparative evaluation.
Understanding clinical outcomes, safety, efficacy and development challenges early on can impact the investment sponsors put forward for a new compound or device. Innovative trial designs are needed to maximize existing outcome data and leverage advanced computational techniques to make increasingly better decisions, accelerating product development and decision making, while reducing overall costs of R&D.
Join Premier Research and InSilicoTrials Technologies for this joint webinar and explore the potential of including in silico modeling and simulation as an integral part of the product development plan.
Join Nach Davé, RPh, MS, Vice President, Development Strategy, Premier Consulting; Abie Ekangaki, PhD, Vice President, Statistical Consulting, Premier Consulting; and Roberta Bursi, PhD, PMP, Co-Founder and Executive Vice President of Research and Development, InSilicoTrials Technologies, for the live webinar on Thursday, September 22, 2022 at 10 a.m. EDT (3 p.m. BST/UK).
For more information or to register for this event, go to Accelerating Product Approval Using In Silico Modeling and Simulation.
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