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In Silico World: Lowering barriers to ubiquitous adoption of In Silico Trials

Deliverables

Report on the certification of validation data

The report will provide identification of the best certification strategy for each of the initial collections This will be reviewed against best practices also in other fields but also by discussing specific issues regarding regulatory aspects In addition a general certification strategy that could be effective for all validation data collections will be identified and discussed In parallel methods to deal with data uncertainty and missing data in validation collections will be described and analysed using existing data collections

Report on initial validation data collections

The report will contain an analysis of the data collections FFRValid HFValid TBValid and StentValid with respect to their intended use and a description of the way they are published In addition a general characterisation of data collection types intended use and the implication for storage usability searchability and certification will be defined and published Where possible this report will also contain datasets of other partners who are contributing early collections in termsof requirements and specific guidelines The analysis will also consider the ethical societal and regulatory requirements

Legal and ethical inventory

This deliverable maps the relevant ethical and legal requirements that partners should take into account from the early stages of the project

Publications

Surrogate model based sensitivity analysis of a one dimensional arterial pulse wave propagation model with correlated input

Author(s): Pjotr Hilhorst
Published in: ISW Zenodo Repository, Issue 3, 2022
Publisher: UvA
DOI: 10.5281/zenodo.7225277

Serverless Approach to Sensitivity Analysis of Computational Models

Author(s): Piotr Kica; Magdalena Otta; Krzysztof Czechowic; Karol Zajac; Piotr Nowakowski; Andrew Narracott; Ian Halliday; Maciej Malawski
Published in: 2023 IEEE/ACM 23rd International Symposium on Cluster, Cloud and Internet Computing (CCGrid), Issue 7, 2023, ISBN 979-8-3503-0119-9
Publisher: IEEE
DOI: 10.1109/ccgrid57682.2023.00064

Scientific and regulatory evaluation of mechanistic in silico drug and disease models in drug development: Building model credibility

Author(s): Flora T. Musuamba, Ine Skottheim Rusten, Raphaëlle Lesage, Giulia Russo, Roberta Bursi, Luca Emili, Gaby Wangorsch, Efthymios Manolis, Kristin E. Karlsson, Alexander Kulesza, Eulalie Courcelles, Jean-Pierre Boissel, Cécile F. Rousseau, Emmanuelle M. Voisin, Rossana Alessandrello, Nuno Curado, Enrico Dall’ara, Blanca Rodriguez, Francesco Pappalardo, Liesbet Geris
Published in: CPT: Pharmacometrics & Systems Pharmacology, 2021, ISSN 2163-8306
Publisher: Nature Publishing Group
DOI: 10.1002/psp4.12669

First blood: An efficient, hybrid one- and zero-dimensional, modular hemodynamic solver

Author(s): Richárd Wéber, Dániel Gyürki, György Paál
Published in: International Journal for Numerical Methods in Biomedical Engineering, Issue Volume 39, Issue 5, 2023, ISSN 2040-7939
Publisher: John Wiley & Sons Ltd.
DOI: 10.1002/cnm.3701

A Credibility Assessment Plan for an In Silico Model that Predicts the Dose–Response Relationship of New Tuberculosis Treatments

Author(s): Cristina Curreli; Valentina Di Salvatore; Giulia Russo; Francesco Pappalardo; Marco Viceconti
Published in: Annals of Biomedical Engineering, Issue Ann Biomed Eng volume 51, 2023, Page(s) 200–210, ISSN 1573-9686
Publisher: Springer Nature
DOI: 10.1007/s10439-022-03078-w

Efficient sensitivity analysis for biomechanical models with correlated inputs

Author(s): Pjotr L. J. Hilhorst, Sjeng Quicken, Frans N. van de Vosse, Wouter Huberts
Published in: International Journal for Numerical Methods in Biomedical Engineering, 2023, ISSN 2040-7939
Publisher: John Wiley & Sons Ltd.
DOI: 10.1002/cnm.3797

Inverse uncertainty quantification of a mechanical model of arterial tissue with surrogate modelling

Author(s): Salome Kakhaia; Pavel Zun; Dongwei Ye; Valeria Krzhizhanovskaya
Published in: Reliability Engineering & System Safety, Issue Volume 238, October 2023, 109393, 2023, ISSN 0951-8320
Publisher: Elsevier BV
DOI: 10.1016/j.ress.2023.109393

Boosting multiple sclerosis lesion segmentation through attention mechanism

Author(s): Alessia Rondinella; Elena Crispino; Francesco Guarnera; Oliver Giudice; Alessandro Ortis; Giulia Russo; Clara Di Lorenzo; Davide Maimone; Francesco Pappalardo; Sebastiano Battiato
Published in: Computers in Biology and Medicine, Issue Volume 161, July 2023, 107021, 2023, ISSN 0010-4825
Publisher: Pergamon Press Ltd.
DOI: 10.1016/j.compbiomed.2023.107021

Uncertainty quantification of a three-dimensional in-stent restenosis model with surrogate modelling

Author(s): Dongwei Ye; Pavel Zun; Valeria Krzhizhanovskaya; Alfons G. Hoekstra
Published in: Journal of the Royal Society Interface, 19(187):20210864. The Royal Society, Issue Volume 19Issue 187, 2022, ISSN 1742-5662
Publisher: Royal Society
DOI: 10.1098/rsif.2021.0864

Automated Prediction of the Response to Neoadjuvant Chemoradiotherapy in Patients Affected by Rectal Cancer

Author(s): Giuseppe Filitto; Francesca Coppola; Nico Curti; Enrico Giampieri; Daniele Dall'Olio; Alessandra Merlotti; Arrigo Cattabriga; Maria Cocozza; Makoto Taninokuchi Tomassoni; Daniel Remondini; Luisa Pierotti; Lidia Strigari; Dajana Cuicchi; Alessandra Guido; Karim Rihawi; Antonietta D'Errico; Francesca Di Fabio; Gilberto Poggioli; Alessio Morganti; Luigi Ricciardiello; Rita Golfieri; Gastone Castellan
Published in: Cancers; Volume 14; Issue 9; Pages: 2231, Issue 10, 2022, ISSN 2072-6694
Publisher: Multidisciplinary Digital Publishing Institute (MDPI)
DOI: 10.3390/cancers14092231

Statistical Properties of a Virtual Cohort for In Silico Trials Generated with a Statistical Anatomy Atlas

Author(s): Antonino A. La Mattina; Fabio Baruffaldi; Mark Taylor; Marco Viceconti
Published in: Annals of Biomedical Engineering: The Journal of the Biomedical Engineering Society, Issue Volume 51, pages 117–124, (2023), 2022, ISSN 1573-9686
Publisher: Springer Nature
DOI: 10.1007/s10439-022-03050-8

Position Paper From the Digital Twins in Healthcare to the Virtual Human Twin: A Moon-Shot Project for Digital Health Research

Author(s): M. Viceconti, M. De Vos, S. Mellone, L. Geris
Published in: IEEE Journal of Biomedical and Health Informatics, Issue vol. 28, no. 1, pp. 491-501, Jan. 2024, 2024, ISSN 2168-2208
Publisher: Institute of Electrical and Electronics Engineers
DOI: 10.1109/jbhi.2023.3323688

Possible Contexts of Use for In Silico Trials Methodologies: A Consensus-Based Review

Author(s): Marco Viceconti; Luca Emili; Payman Afshari; Eulalie Courcelles; Cristina Curreli; Nele Famaey; Liesbet Geris; Marc Horner; Maria Cristina Jori; Alexander Kulesza; Axel Loewe; Michael Neidlin; Markus Reiterer; Cécile F. Rousseau; Giulia Russo; Simon J. Sonntag; Emmanuelle M. Voisin; Francesco Pappalardo
Published in: IEEE Journal of Biomedical and Health Informatics, Issue Volume: 25 Issue: 10, 2021, ISSN 2168-2208
Publisher: IEEE
DOI: 10.1109/jbhi.2021.3090469

Toward A Regulatory Pathway for the Use of in Silico Trials in the CE Marking of Medical Devices

Author(s): Francesco Pappalardo; John Wilkinson; Francois Busquet; Antoine Bril; Mark Palmer; Barry Walker; Cristina Curreli; Giulia Russo; Thierry Marchal; Elena Toschi; Rossana Alessandrello; Vincenzo Costignola; Ingrid Klingmann; Martina Contin; Bernard Staumont; Matthias Woiczinski; Christian Kaddick; Valentina Di Salvatore; Alessandra Aldieri; Liesbet Geris; Marco Viceconti
Published in: IEEE Journal of Biomedical and Health Informatics, Issue Volume: 26, Issue: 11, 2022, Page(s) 5282 - 5286, ISSN 2168-2208
Publisher: IEEE
DOI: 10.1109/jbhi.2022.3198145

Mapping the use of computational modelling and simulation in clinics: A survey

Author(s): Raphaëlle Lesage; Michiel Van Oudheusden; Silvia Schievano; Ine Van Hoyweghen; Liesbet Geris; Claudio Capelli
Published in: Frontiers in Medical Technology, Issue Front. Med. Technol., Volume 5 - 2023, 2023, ISSN 2673-3129
Publisher: Frontiers
DOI: 10.3389/fmedt.2023.1125524

Experimental validation of a subject-specific finite element model of lumbar spine segment using digital image correlation

Author(s): Chiara Garavelli; Cristina Curreli; Marco Palanca; Alessandra Aldieri; Luca Cristofolini; Marco Viceconti
Published in: PLOS ONE, Issue September 9, 2022, 2022, ISSN 1932-6203
Publisher: Public Library of Science
DOI: 10.1371/journal.pone.0272529

Proximal femur bone mineral density in osteoporotic patients a review of placebo groups in clinical trials

Author(s): Oliviero, Sara
Published in: ISW Zenodo repository, Issue 5, 2022
Publisher: UNIBO
DOI: 10.5281/zenodo.7248963

Computer modelling and simulation in clinics: mapping usage and opinions for advancing in silico medicine

Author(s): Raphaelle Lesage; Michiel Van Oudheusden; Martina Contin; Silvia Schievano; Liesbet Geris; Claudio Capelli
Published in: ISW Zenodo Repository, Issue 6, 2022
Publisher: VPHi KU Leuven
DOI: 10.5281/zenodo.7437507

Proposal for curricula to train and retrain different stakeholders on In Silico Trials

Author(s): Vander Linden, Klaas; Van Looy, Guy; Davico, Giorgio; Viceconti, Marco; Vander Sloten, Jos
Published in: ISW Zenodo repository, 2023
Publisher: KU Leuven
DOI: 10.5281/zenodo.10400657

Mapping the use of computer modelling and simulation in clinics

Author(s): Raphaëlle; Michiel; Silvia; Ine; Claudio; Giulia; Martina; Roberta; Goran
Published in: ISW Zenodo Repository, Issue 7, 2023
Publisher: VPHi
DOI: 10.5281/zenodo.7974392

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