Credibility assessment of in silico clinical trials for medical devices.

ABSTRACT: In silico clinical trials (ISCTs) are an emerging method in modeling and simulation where medical interventions are evaluated using computational models of patients. ISCTs have the potential to provide cost-effective, time-efficient, and ethically favorable alternatives for evaluating the safety and effectiveness of medical devices. However, ensuring the credibility of ISCT results is a significant challenge. This paper aims to identify unique considerations for assessing the credibility of ISCTs and proposes an ISCT credibility assessment workflow based on recently published model assessment frameworks. First, we review various ISCTs described in the literature, carefully selected to showcase the range of methodological options available. These studies cover a wide variety of devices, rea

SUBMITTER: Pathmanathan P 

PROVIDER: S-EPMC11309390 | biostudies-literature | 2024 Aug

REPOSITORIES: biostudies-literature