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

Rezultaty

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

In-depth analysis of legal and ethical requirements

This deliverable further elaborates on the main ethical and legal requirements identified in D9.1, in light of in-depth research including extensive analysis of legislation, case law and doctrine.

Final report on Advanced solutions

Report describing final versions of modelling track solutions.

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

Policy Brief

The policy brief is a report that is produced based on the preparatory phases of stakeholder outreach activities (networking & desk review). In the report, for each stakeholder group, the results of the data analysis will be presented and discussed and the resulting specific engagement actions will be listed. The final report document will be available by M36.

Publikacje

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

Autorzy: Pjotr Hilhorst
Opublikowane w: ISW Zenodo Repository, Numer 3, 2022
Wydawca: UvA
DOI: 10.5281/zenodo.7225277

Serverless Approach to Sensitivity Analysis of Computational Models

Autorzy: Piotr Kica; Magdalena Otta; Krzysztof Czechowic; Karol Zajac; Piotr Nowakowski; Andrew Narracott; Ian Halliday; Maciej Malawski
Opublikowane w: 2023 IEEE/ACM 23rd International Symposium on Cluster, Cloud and Internet Computing (CCGrid), Numer 7, 2023, ISBN 979-8-3503-0119-9
Wydawca: 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

Autorzy: 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
Opublikowane w: CPT: Pharmacometrics & Systems Pharmacology, 2021, ISSN 2163-8306
Wydawca: Nature Publishing Group
DOI: 10.1002/psp4.12669

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

Autorzy: Richárd Wéber, Dániel Gyürki, György Paál
Opublikowane w: International Journal for Numerical Methods in Biomedical Engineering, Numer Volume 39, Numer 5, 2023, ISSN 2040-7939
Wydawca: 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

Autorzy: Cristina Curreli; Valentina Di Salvatore; Giulia Russo; Francesco Pappalardo; Marco Viceconti
Opublikowane w: Annals of Biomedical Engineering, Numer Ann Biomed Eng volume 51, 2023, Strona(/y) 200–210, ISSN 1573-9686
Wydawca: Springer Nature
DOI: 10.1007/s10439-022-03078-w

Efficient sensitivity analysis for biomechanical models with correlated inputs

Autorzy: Pjotr L. J. Hilhorst, Sjeng Quicken, Frans N. van de Vosse, Wouter Huberts
Opublikowane w: International Journal for Numerical Methods in Biomedical Engineering, 2023, ISSN 2040-7939
Wydawca: John Wiley & Sons Ltd.
DOI: 10.1002/cnm.3797

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

Autorzy: Salome Kakhaia; Pavel Zun; Dongwei Ye; Valeria Krzhizhanovskaya
Opublikowane w: Reliability Engineering & System Safety, Numer Volume 238, October 2023, 109393, 2023, ISSN 0951-8320
Wydawca: Elsevier BV
DOI: 10.1016/j.ress.2023.109393

Boosting multiple sclerosis lesion segmentation through attention mechanism

Autorzy: Alessia Rondinella; Elena Crispino; Francesco Guarnera; Oliver Giudice; Alessandro Ortis; Giulia Russo; Clara Di Lorenzo; Davide Maimone; Francesco Pappalardo; Sebastiano Battiato
Opublikowane w: Computers in Biology and Medicine, Numer Volume 161, July 2023, 107021, 2023, ISSN 0010-4825
Wydawca: Pergamon Press Ltd.
DOI: 10.1016/j.compbiomed.2023.107021

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

Autorzy: Dongwei Ye; Pavel Zun; Valeria Krzhizhanovskaya; Alfons G. Hoekstra
Opublikowane w: Journal of the Royal Society Interface, 19(187):20210864. The Royal Society, Numer Volume 19Numer 187, 2022, ISSN 1742-5662
Wydawca: Royal Society
DOI: 10.1098/rsif.2021.0864

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

Autorzy: 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
Opublikowane w: Cancers; Volume 14; Numer 9; Pages: 2231, Numer 10, 2022, ISSN 2072-6694
Wydawca: 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

Autorzy: Antonino A. La Mattina; Fabio Baruffaldi; Mark Taylor; Marco Viceconti
Opublikowane w: Annals of Biomedical Engineering: The Journal of the Biomedical Engineering Society, Numer Volume 51, pages 117–124, (2023), 2022, ISSN 1573-9686
Wydawca: 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

Autorzy: M. Viceconti, M. De Vos, S. Mellone, L. Geris
Opublikowane w: IEEE Journal of Biomedical and Health Informatics, Numer vol. 28, no. 1, pp. 491-501, Jan. 2024, 2024, ISSN 2168-2208
Wydawca: 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

Autorzy: 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
Opublikowane w: IEEE Journal of Biomedical and Health Informatics, Numer Volume: 25 Numer: 10, 2021, ISSN 2168-2208
Wydawca: 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

Autorzy: 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
Opublikowane w: IEEE Journal of Biomedical and Health Informatics, Numer Volume: 26, Numer: 11, 2022, Strona(/y) 5282 - 5286, ISSN 2168-2208
Wydawca: IEEE
DOI: 10.1109/jbhi.2022.3198145

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

Autorzy: Raphaëlle Lesage; Michiel Van Oudheusden; Silvia Schievano; Ine Van Hoyweghen; Liesbet Geris; Claudio Capelli
Opublikowane w: Frontiers in Medical Technology, Numer Front. Med. Technol., Volume 5 - 2023, 2023, ISSN 2673-3129
Wydawca: Frontiers
DOI: 10.3389/fmedt.2023.1125524

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

Autorzy: Chiara Garavelli; Cristina Curreli; Marco Palanca; Alessandra Aldieri; Luca Cristofolini; Marco Viceconti
Opublikowane w: PLOS ONE, Numer September 9, 2022, 2022, ISSN 1932-6203
Wydawca: 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

Autorzy: Oliviero, Sara
Opublikowane w: ISW Zenodo repository, Numer 5, 2022
Wydawca: UNIBO
DOI: 10.5281/zenodo.7248963

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

Autorzy: Raphaelle Lesage; Michiel Van Oudheusden; Martina Contin; Silvia Schievano; Liesbet Geris; Claudio Capelli
Opublikowane w: ISW Zenodo Repository, Numer 6, 2022
Wydawca: VPHi KU Leuven
DOI: 10.5281/zenodo.7437507

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

Autorzy: Vander Linden, Klaas; Van Looy, Guy; Davico, Giorgio; Viceconti, Marco; Vander Sloten, Jos
Opublikowane w: ISW Zenodo repository, 2023
Wydawca: KU Leuven
DOI: 10.5281/zenodo.10400657

Mapping the use of computer modelling and simulation in clinics

Autorzy: Raphaëlle; Michiel; Silvia; Ine; Claudio; Giulia; Martina; Roberta; Goran
Opublikowane w: ISW Zenodo Repository, Numer 7, 2023
Wydawca: VPHi
DOI: 10.5281/zenodo.7974392

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