Advancing in Silico Clinical Trials for Regulatory Adoption and Innovation
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
- Dejan Krsmanovic
- Elazer R. Edelman (ORCID: https://orcid.org/0000-0002-7832-7156)
- Nenad Filipović (ORCID: https://orcid.org/0000-0001-9964-5615)
- Lorenza Petrini (ORCID: https://orcid.org/0000-0002-6349-1586)
- François‐Henri Boissel
- Ali Kiapour (ORCID: https://orcid.org/0000-0002-7837-9191)
- Martin Fawdry
- Luca Emili (ORCID: https://orcid.org/0000-0001-6078-8766)
- Liesbet Geris (ORCID: https://orcid.org/0000-0002-8180-1445)
- David Flynn
- Dimitrios I. Fotiadis (ORCID: https://orcid.org/0000-0002-7362-5082)
- Markus Réitérer
- Flora T. Musuamba (ORCID: https://orcid.org/0000-0001-8276-8870)
- Francesco Pappalardo (ORCID: https://orcid.org/0000-0003-1668-3320)
- Maria Cristina Jori (ORCID: https://orcid.org/0000-0001-9142-3399)
- Alfons G. Hoekstra (ORCID: https://orcid.org/0000-0002-3955-2449)
- Marco Viceconti (ORCID: https://orcid.org/0000-0002-2293-1530)
- Robert A. Byrne (ORCID: https://orcid.org/0000-0001-5224-6393)
- Georgia S. Karanasiou (ORCID: https://orcid.org/0000-0001-9478-0375)
- Lampros K. Michalis (ORCID: https://orcid.org/0000-0001-8834-4462)
- Thierry Marchal
- Klaus Zeier
Institutions
- Harvard University (US)
- University of Kragujevac (RS)
- University of Ioannina (GR)
- Ansys (United States) (US)
- Boston Scientific (United States) (US)
- University of Catania (IT)
- Massachusetts General Hospital (US)
- Mediolanum Cardio Research (IT)
- Medtronic (United States) (US)
- Collaborative Drug Discovery (United States) (US)
- Institute for Medical Research (US)
- Clinical Centre of Kragujevac (RS)
- Deutsches Institut für Normung (DE)
- University of Amsterdam (NL)
- University of Bologna (IT)
- Politecnico di Milano (IT)
- KU Leuven (BE)
Publication Details
- Journal
- IEEE Journal of Biomedical and Health Informatics
- Published
- 2024-11-08
- DOI
- https://doi.org/10.1109/jbhi.2024.3486538
- Citations
- 7
- Primary Topic
- Health Systems, Economic Evaluations, Quality of Life
- Type
- article
- Field-Weighted Citation Impact
- 7.90
Funders
- Boston Scientific Corporation
- Royal College of Surgeons in Ireland
- European Commission
- Cardiovascular Research Institute of Vermont, Larner College of Medicine, University of Vermont