A Framework for In Silico Clinical Trials for Medical Devices Using Concepts From Model Verification, Validation, and Uncertainty Quantification (VVUQ)
Abstract:The rising costs of clinical trials for medical devices in recent years has led to an increased interest in so-called in silico clinical trials, where simulation results are used to supplement or to replace those obtained from human patients. Here we present a framework for executing such a trial. This framework relies heavily on ideas already developed for model verification, validation, and uncertainty quantification. The framework uses results from an initial cohort of human patients as model validation dat… Show more
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