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Review
. 2023 Jul 26;21(1):501.
doi: 10.1186/s12967-023-04290-5.

Adapting modeling and simulation credibility standards to computational systems biology

Lillian T Tatka  1 , Lucian P Smith  2 , Joseph L Hellerstein  3 , Herbert M Sauro  2
Affiliations
Review

Adapting modeling and simulation credibility standards to computational systems biology

Lillian T Tatka et al. J Transl Med. .

Abstract

Computational models are increasingly used in high-impact decision making in science, engineering, and medicine. The National Aeronautics and Space Administration (NASA) uses computational models to perform complex experiments that are otherwise prohibitively expensive or require a microgravity environment. Similarly, the Food and Drug Administration (FDA) and European Medicines Agency (EMA) have began accepting models and simulations as forms of evidence for pharmaceutical and medical device approval. It is crucial that computational models meet a standard of credibility when using them in high-stakes decision making. For this reason, institutes including NASA, the FDA, and the EMA have developed standards to promote and assess the credibility of computational models and simulations. However, due to the breadth of models these institutes assess, these credibility standards are mostly qualitative and avoid making specific recommendations. On the other hand, modeling and simulation in systems biology is a narrower domain and several standards are already in place. As systems biology models increase in complexity and influence, the development of a credibility assessment system is crucial. Here we review existing standards in systems biology, credibility standards in other science, engineering, and medical fields, and propose the development of a credibility standard for systems biology models.

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Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
The Committee on Credible Practice of Modeling and Simulation in Healthcare 10 rules of model credibility
Fig. 2
Fig. 2
Categories of the NASA Credibility Assessment Scale (CAS)
See this image and copyright information in PMC

References

    1. Chengyuan W, Si L, Ademiloye Adesola S, Perumal N. Biomechanics of cells and subcellular components: a comprehensive review of computational models and applications. Int J Numer Methods Biomed Eng. 2021 doi: 10.1002/cnm.3520. - DOI - PubMed
    1. Hassell JM, Newbold T, Dobson AP, Linton YMa, Franklinos LV, Zimmerman D, Lohan KMP. Towards an ecosystem model of infectious disease. Nature Ecol Amp Evol. 2021;5(7):907–918. doi: 10.1038/s41559-021-01454-8. - DOI - PubMed
    1. Bartocci E, Lió P. Computational modeling, formal analysis, and tools for systems biology. PLOS Comput Biol. 2016;12(1):e1004591. doi: 10.1371/journal.pcbi.1004591. - DOI - PMC - PubMed
    1. Assessing the credibility of computational modeling and simulation in medical device submissions: Draft guidance for industry and food and drug administration staff. U.S. Food and Drug Administration, 2021.
    1. Janis S, Veronica P, James C, Sauro HM. Standards, dissemination, and best practices in systems biology. Current Opin Biotechnol. 2023;81:102922. doi: 10.1016/j.copbio.2023.102922. - DOI - PMC - PubMed

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