{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,31]],"date-time":"2026-08-31T23:54:41Z","timestamp":1788220481760,"version":"build-2803163510"},"reference-count":75,"publisher":"Public Library of Science (PLoS)","issue":"8","license":[{"start":{"date-parts":[[2024,8,8]],"date-time":"2024-08-08T00:00:00Z","timestamp":1723075200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/publicdomain\/zero\/1.0\/"}],"content-domain":{"domain":["www.ploscompbiol.org"],"crossmark-restriction":false},"short-container-title":["PLoS Comput Biol"],"abstract":"<jats:p>\n                    <jats:italic>In silico<\/jats:italic>\n                    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, reasons for conducting ISCTs, patient model generation approaches including subject-specific versus \u2018synthetic\u2019 virtual patients, complexity levels of devices and patient models, incorporation of clinician or clinical outcome models, and methods for integrating ISCT results with real-world clinical trials. We next discuss how verification, validation, and uncertainty quantification apply to ISCTs, considering the range of ISCT approaches identified. Based on our analysis, we then present a hierarchical workflow for assessing ISCT credibility, using a general credibility assessment framework recently published by the FDA\u2019s Center for Devices and Radiological Health. Overall, this work aims to promote standardization in ISCTs and contribute to the wider adoption and acceptance of ISCTs as a reliable tool for evaluating medical devices.\n                  <\/jats:p>","DOI":"10.1371\/journal.pcbi.1012289","type":"journal-article","created":{"date-parts":[[2024,8,8]],"date-time":"2024-08-08T13:21:26Z","timestamp":1723123286000},"page":"e1012289","update-policy":"https:\/\/doi.org\/10.1371\/journal.pcbi.corrections_policy","source":"Crossref","is-referenced-by-count":56,"title":["Credibility assessment of in silico clinical trials for medical devices"],"prefix":"10.1371","volume":"20","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-2111-6689","authenticated-orcid":true,"given":"Pras","family":"Pathmanathan","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kenneth","family":"Aycock","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andreu","family":"Badal","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ramin","family":"Bighamian","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jeff","family":"Bodner","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Brent A.","family":"Craven","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Steven","family":"Niederer","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"340","published-online":{"date-parts":[[2024,8,8]]},"reference":[{"key":"pcbi.1012289.ref001","unstructured":"ASME, ASME V&V 40\u20132018: Assessing Credibility of Computational Modeling Through Verification and Validation: Application to Medical Devices. 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2023)."},{"issue":"7","key":"pcbi.1012289.ref032","doi-asserted-by":"crossref","first-page":"e185474","DOI":"10.1001\/jamanetworkopen.2018.5474","article-title":"Evaluation of digital breast tomosynthesis as replacement of full-field digital mammography using an in silico imaging trial","volume":"1","author":"A Badano","year":"2018","journal-title":"JAMA network open"},{"key":"pcbi.1012289.ref033","unstructured":"FDA. https:\/\/www.fda.gov\/medical-devices\/recently-approved-devices\/et-control-p210018 (accessed Oct 2023)."},{"issue":"5","key":"pcbi.1012289.ref034","doi-asserted-by":"crossref","first-page":"1130","DOI":"10.1213\/ANE.0b013e3182973687","article-title":"Closed-loop control of anesthesia: a primer for anesthesiologists","volume":"117","author":"GA Dumont","year":"2013","journal-title":"Anesthesia & Analgesia"},{"issue":"7","key":"pcbi.1012289.ref035","doi-asserted-by":"crossref","first-page":"1905","DOI":"10.1109\/TBME.2018.2880927","article-title":"Development and in 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Virtual patient generation using physiological models through a compressed latent parameterization. in 2020 American Control Conference (ACC). 2020. 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In-silico pre-clinical trials for implantable cardioverter defibrillators. in 2016 38th Annual International Conference of the IEEE Engineering in Medicine and Biology Society (EMBC). 2016. 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Trans. R. Soc. A"},{"issue":"10","key":"pcbi.1012289.ref050","doi-asserted-by":"crossref","first-page":"5679","DOI":"10.1118\/1.4928676","article-title":"Monte Carlo reference data sets for imaging research: Executive summary of the report of AAPM Research Committee Task Group 195","volume":"42","author":"I Sechopoulos","year":"2015","journal-title":"Medical physics"},{"key":"pcbi.1012289.ref051","doi-asserted-by":"crossref","first-page":"565","DOI":"10.1007\/s13239-018-00376-0","article-title":"Multiple aneurysms anatomy challenge 2018 (MATCH): phase I: segmentation","volume":"9","author":"P. 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Niederer","year":"2010","journal-title":"Cardiovascular research"},{"issue":"1","key":"pcbi.1012289.ref058","doi-asserted-by":"crossref","first-page":"122","DOI":"10.1109\/JPROC.2011.2161241","article-title":"Cyber\u2013physical modeling of implantable cardiac medical devices","volume":"100","author":"Z Jiang","year":"2011","journal-title":"Proceedings of the IEEE"},{"key":"pcbi.1012289.ref059","doi-asserted-by":"crossref","first-page":"627","DOI":"10.1007\/s10439-020-02571-4","article-title":"Patient-specific bicuspid aortic valve biomechanics: a magnetic resonance imaging integrated fluid\u2013structure interaction approach","volume":"49","author":"M Emendi","year":"2021","journal-title":"Annals of biomedical engineering"},{"key":"pcbi.1012289.ref060","doi-asserted-by":"crossref","first-page":"154","DOI":"10.1007\/s10439-014-1082-9","article-title":"Accuracy and reproducibility of patient-specific hemodynamic models of stented intracranial aneurysms: report on the Virtual 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James","year":"2013"},{"issue":"5","key":"pcbi.1012289.ref067","doi-asserted-by":"crossref","first-page":"654","DOI":"10.1161\/CIRCULATIONAHA.105.594929","article-title":"Receiver-operating characteristic analysis for evaluating diagnostic tests and predictive models","volume":"115","author":"KH Zou","year":"2007","journal-title":"Circulation"},{"issue":"2","key":"pcbi.1012289.ref068","doi-asserted-by":"crossref","first-page":"141","DOI":"10.11613\/BM.2015.015","article-title":"Understanding bland altman analysis","volume":"25","author":"D Giavarina","year":"2015","journal-title":"Biochemia medica"},{"issue":"1","key":"pcbi.1012289.ref069","doi-asserted-by":"crossref","first-page":"7","DOI":"10.3109\/10976649909080829","article-title":"Normal human right and left ventricular mass, systolic function, and gender differences by cine magnetic resonance imaging","volume":"1","author":"CH Lorenz","year":"1999","journal-title":"Journal of Cardiovascular Magnetic 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