Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Review
. 2019 Sep 27;20(5):1699-1708.
doi: 10.1093/bib/bby043.

In silico clinical trials: concepts and early adoptions

Francesco Pappalardo  1 , Giulia Russo  2 , Flora Musuamba Tshinanu  3 , Marco Viceconti  4
Affiliations
Review

In silico clinical trials: concepts and early adoptions

Francesco Pappalardo et al. Brief Bioinform. .

Abstract

Innovations in information and communication technology infuse all branches of science, including life sciences. Nevertheless, healthcare is historically slow in adopting technological innovation, compared with other industrial sectors. In recent years, new approaches in modelling and simulation have started to provide important insights in biomedicine, opening the way for their potential use in the reduction, refinement and partial substitution of both animal and human experimentation. In light of this evidence, the European Parliament and the United States Congress made similar recommendations to their respective regulators to allow wider use of modelling and simulation within the regulatory process. In the context of in silico medicine, the term 'in silico clinical trials' refers to the development of patient-specific models to form virtual cohorts for testing the safety and/or efficacy of new drugs and of new medical devices. Moreover, it could be envisaged that a virtual set of patients could complement a clinical trial (reducing the number of enrolled patients and improving statistical significance), and/or advise clinical decisions. This article will review the current state of in silico clinical trials and outline directions for a full-scale adoption of patient-specific modelling and simulation in the regulatory evaluation of biomedical products. In particular, we will focus on the development of vaccine therapies, which represents, in our opinion, an ideal _target for this innovative approach.

Keywords: computational modelling; in silico clinical trials; regulatory agencies; systems biomedicine.

PubMed Disclaimer

Similar articles

  • Advancing In Silico Clinical Trials for Regulatory Adoption and Innovation.
    Karanasiou G, Edelman E, Boissel FH, Byrne R, Emili L, Fawdry M, Filipovic N, Flynn D, Geris L, Hoekstra A, Jori MC, Kiapour A, Krsmanovic D, Marchal T, Musuamba F, Pappalardo F, Petrini L, Reiterer M, Viceconti M, Zeier K, Michalis LK, Fotiadis DI. Karanasiou G, et al. IEEE J Biomed Health Inform. 2024 Nov 8;PP. doi: 10.1109/JBHI.2024.3486538. Online ahead of print. IEEE J Biomed Health Inform. 2024. PMID: 39514353
  • In Silico Trial Approach for Biomedical Products: A Regulatory Perspective.
    Jose J, S S, Mathew B, Parambi DGT. Jose J, et al. Comb Chem High Throughput Screen. 2022;25(12):1991-2000. doi: 10.2174/1386207325666220105150147. Comb Chem High Throughput Screen. 2022. PMID: 34986768 Review.
  • Trial design and reporting standards for intra-arterial cerebral thrombolysis for acute ischemic stroke.
    Higashida RT, Furlan AJ, Roberts H, Tomsick T, Connors B, Barr J, Dillon W, Warach S, Broderick J, Tilley B, Sacks D; Technology Assessment Committee of the American Society of Interventional and Therapeutic Neuroradiology; Technology Assessment Committee of the Society of Interventional Radiology. Higashida RT, et al. Stroke. 2003 Aug;34(8):e109-37. doi: 10.1161/01.STR.0000082721.62796.09. Epub 2003 Jul 17. Stroke. 2003. PMID: 12869717
  • Credibility of In Silico Trial Technologies-A Theoretical Framing.
    Viceconti M, Juarez MA, Curreli C, Pennisi M, Russo G, Pappalardo F. Viceconti M, et al. IEEE J Biomed Health Inform. 2020 Jan;24(1):4-13. doi: 10.1109/JBHI.2019.2949888. Epub 2019 Oct 28. IEEE J Biomed Health Inform. 2020. PMID: 31670687
  • In silico modelling of physiologic systems.
    Colquitt RB, Colquhoun DA, Thiele RH. Colquitt RB, et al. Best Pract Res Clin Anaesthesiol. 2011 Dec;25(4):499-510. doi: 10.1016/j.bpa.2011.08.006. Best Pract Res Clin Anaesthesiol. 2011. PMID: 22099916 Review.
See all similar articles

Cited by

See all "Cited by" articles

Publication types

  NODES
Idea 1
idea 1
innovation 4
twitter 2