Year: 2024
Type: article
Abstract: The evolution of information and communication technologies has affected all fields of science, including health sciences. However, the rate of technological innovation adoption by the healthcare sector has been historically slow, compared to other industrial sectors. Innovation in computer modeling and simulation approaches has changed the landscape in biomedical applications and biomedicine, paving the way for their potential contribution in reducing, refining, and partially replacing animal and human clinical trials. In Silico Clinical Trials (ISCT) allow the development of virtual populations used in the safety and efficacy testing of new drugs and medical devices. This White Paper presents the current framework for ISCT, the role of in silico medicine research communities, the different perspectives (research, scientific, clinical, regulatory, standardization, data quality, legal and ethical), the barriers, challenges, and opportunities for ISCT adoption. In addition, an overview of successful ISCT projects, market-available platforms, and FDA- approved paradigms, along with their vision, mission and outcomes are presented.
Authors: Georgia Karanasiou, Elazer Edelman, François-Henri Boissel, Robert Byrne, Luca Emili, Martin Fawdry, Nenad Filipović, David Flynn, Liesbet Geris, Alfons Hoekstra, Maria Cristina Jori, Ali Kiapour, Dejan Krsmanovic, Thierry Marchal, Flora Musuamba, Francesco Pappalardo, Lorenza Petrini, Markus Reiterer, Marco Viceconti, Klaus Zeier, Lampros K. Michalis, Dimitrios I. Fotiadis
Institutions: University of Ioannina, Foundation for Research and Technology Hellas, Massachusetts Institute of Technology, Royal College of Surgeons in Ireland, Mater Misericordiae University Hospital, University of Kragujevac, Boston Scientific (United States), KU Leuven, University of Amsterdam, Mediolanum Cardio Research, Harvard University, Massachusetts General Hospital, Ansys (United States), European Medicines Agency, University of Catania, Politecnico di Milano, Medtronic (United States), University of Bologna, Deutsches Institut für Normung
Language: English
Subfield: Health Informatics
Field: Medicine
Domain: Health Sciences
Open Access status: green
OpenAlex ID: W4404179201