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POSITION PAPER: Credibility of In Silico Trial Technologies: A Theoretical Framing [article]

Marco Viceconti, Miguel A. Juárez, Cristina Curreli, Marzio Pennisi, Giulia Russo, Francesco Pappalardo
2019 arXiv   pre-print
In this position paper we propose a theoretical framing for the problem of assessing the credibility of a predictive models for In Silico Trials, which accounts for the epistemic specificity of this research  ...  But this poses a foundational problem: in the domain of biomedical research the use of computer modelling is relatively recent, without a widely accepted epistemic framing for problem of model credibility  ...  ACKNOWLEDGMENT The authors would like to thank the many people within whom we discussed of the contents of this manuscript, receiving useful advice. Among the others we would like to name Tina  ... 
arXiv:1909.04660v2 fatcat:kvms22usj5gk7pms4wm35usjg4

Scientific and regulatory evaluation of mechanistic in silico drug and disease models in drug development: building model credibility

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 (+8 others)
2021 CPT: Pharmacometrics & Systems Pharmacology  
To illustrate the feasibility of the proposed approach, we have applied it to three real case examples in the context of drug development, using a credibility matrix currently being tested as a quick-start  ...  The value of in silico methods in drug development and evaluation has been demonstrated repeatedly and convincingly.  ...  With the combination of increased uptake and expanding technologies, it is essential to have clarity and consensus in the in silico community on the most appropriate tools for in silico model evaluation  ... 
doi:10.1002/psp4.12669 pmid:34102034 pmcid:PMC8376137 fatcat:nxmf3ld4nffpre37462ybpglkq

SIMCor. Deliverable 10.1: In-silico trial impact assessment framework (ECRIN, M12)

Burç Aydin, Christian Ohmann
2021 Zenodo  
The objective of this deliverable is to define and develop a framework for estimating the impact of in-silico methods and technologies on clinical and preclinical trials, laying the basis for the assessment  ...  The next step is to establish baseline credibility evidence with the goal that the model is ready to use for the in-silico trial.  ...  Philos Trans A Math Phys Eng Sci. 2020; 378: Viceconti et al., POSITION PAPER: Credibility of In Silico Trial Technologies: A Theoretical Framing.  ... 
doi:10.5281/zenodo.6353627 fatcat:5llrvkyytjbbrfgfw36gumqecu

In silico Clinical Trials: A New Dawn in Biomedical Research?

Ilaria Malagrinò
2016 Humana.Mente: Journal of Philosophical Studies  
In this paper I will analyze an effective example of this new trend in biomedical research: the Avicenna project and its "roadmap for clinical trials".  ...  Nowadays, scientific knowledge seems to be increasingly generated using technological methods, but also governed by technological demands and conducted by new technical ways of learning.  ...  and determining early examples of in silico clinical trials.  ... 
doaj:3f88271ac3404685876ab15b2a98a2ea fatcat:67vif4t57vfxvg5s254l3emoiu

In Silico Trials: Verification, Validation And Uncertainty Quantification Of Predictive Models Used In The Regulatory Evaluation Of Biomedical Products

Marco Viceconti, Francesco Pappalardo, Blanca Rodriguez, Marc Horner, Jeff Bischoff, Flora Musuamba Tshinanu
2020 Methods  
This involves the assessment of the overall "credibility" that such a method has in providing specific evidence for a given regulatory procedure.  ...  required, which should be considered early on in the development/use of any (new) in silico evidence.  ...  A recent paper from some of the authors tries to frame this into a proper theoretical framework [45] .  ... 
doi:10.1016/j.ymeth.2020.01.011 pmid:31991193 pmcid:PMC7883933 fatcat:d462khdho5fddh2k2waycbys4y

Project presentation

Anna Rizzo
2021 Zenodo  
language and in the form of a high-level summary, to serve in project communication and dissemination.  ...  The project presentation is a document illustrating the project including its rationale, mission and objectives, consortium composition and role of partners, implementation and expected impacts, in a common  ...  A standardized multi-level validation process and sensitivity analysis will guarantee statistical credibility for in-silico tests and the platform as a whole, proving solid experimental ground for regulatory  ... 
doi:10.5281/zenodo.4644534 fatcat:6xojm3s2jbadto2deyao47gcgq

Solving the Evidence Interpretability Crisis in Health Technology Assessment: A Role for Mechanistic Models?

Eulalie Courcelles, Jean-Pierre Boissel, Jacques Massol, Ingrid Klingmann, Riad Kahoul, Marc Hommel, Emmanuel Pham, Alexander Kulesza
2022 Frontiers in Medical Technology  
Health technology assessment (HTA) aims to be a systematic, transparent, unbiased synthesis of clinical efficacy, safety, and value of medical products (MPs) to help policymakers, payers, clinicians, and  ...  In parallel, regulatory consideration of model informed drug development (MIDD) has brought attention to mechanistic modeling techniques that could in fact be relevant for HTA.  ...  Running mechanistic model based in silico trials with a theoretically infinite number of patients can support evidence in rare settings and place population-level results in relation to individual simulated  ... 
doi:10.3389/fmedt.2022.810315 pmid:35281671 pmcid:PMC8907708 fatcat:zbir5esrjbbt5fuusr2ytkvhvu

In Silico World D9.1 Legal and ethical inventory

Elisabetta Biasin, Anton Vedder
2022 Zenodo  
Data Governance: In healthcare and in silico trials, the sharing of data across healthcare facilities may be considered a key factor for the development, testing, and validation of in silico models.  ...  of legislation and ethical principles that are relevant to the In Silico project, and thus, in silico trials.  ...  Theoretical framework Given their inherent novelty for society, in silico trials require the study of its ethical aspects. 255 The ethical analysis applied by WP9 follows a principlist approach.  ... 
doi:10.5281/zenodo.7104078 fatcat:l33zbizyzjg2jlfpj35eqvuume

Next generation physiologically based kinetic (NG-PBK) models in support of regulatory decision making

A. Paini, J.A. Leonard, E. Joossens, J.G.M. Bessems, A. Desalegn, J.L. Dorne, J.P. Gosling, M.B. Heringa, M. Klaric, T. Kliment, N.I. Kramer, G. Loizou (+12 others)
2019 Computational Toxicology  
2) constructing PBK models without in vivo animal kinetic data, while relying solely on in vitro or in silico methods for model parameterization; and 3) assessing the validity and credibility of PBK models  ...  The strengths, uncertainties, and limitations of PBK models developed using in vitro or in silico data are discussed in an effort to establish a higher degree of confidence in the application of such models  ...  Prieto-Peraita, A. Richarz, and M. Whelan of the JRC for contributing to discussions during the workshop.  ... 
doi:10.1016/j.comtox.2018.11.002 pmid:31008414 pmcid:PMC6472623 fatcat:ojiwvt5rnjcvxmxojmesqy324e

How to Validate in silico Deployment of Coronary Stents: Strategies and Limitations in the Choice of Comparator

Francesca Berti, Luca Antonini, Gianluca Poletti, Constantino Fiuza, Ted J. Vaughan, Francesco Migliavacca, Lorenza Petrini, Giancarlo Pennati
2021 Frontiers in Medical Technology  
The proof of the reliability of a numerical model is becoming of paramount importance in the era of in silico trials.  ...  of verification and validation activities performed for proving the credibility of models.  ...  The authors acknowledge Alessandra Faicchio, Francesca Gallo, Mara Putignano, Selene Zanelli, Martina Ventre, and Eleonora Pavesi for their technical support in the preliminary phase of the study.  ... 
doi:10.3389/fmedt.2021.702656 pmid:35047942 pmcid:PMC8757815 fatcat:nicdgtffxbd2fiu7qklqdwswpu

Will Artificial Intelligence for Drug Discovery Impact Clinical Pharmacology?

Alex Zhavoronkov, Quentin Vanhaelen, Tudor I. Oprea
2020 Clinical Pharmacology and Therapeutics  
We address difficulties and AI/ML developments for target identification, their use in generative chemistry for small molecule drug discovery, and the potential role of AI/ML in clinical trial outcome  ...  We briefly discuss current trends in the use of AI/ML in healthcare and the impact of AI/ML context of the daily practice of clinical pharmacologists.  ...  This is an open access article under the terms of the Creative Commons Attribution-NonCommercial License, which permits use, distribution and reproduction in any medium, provided the original work is properly  ... 
doi:10.1002/cpt.1795 pmid:31957003 pmcid:PMC7158211 fatcat:dtowooen6fhwvhnnew2e75nify

Alternative approaches for medical countermeasures to biological and chemical terrorism and warfare
EN

Thomas Hartung
2012 ALTEX: Alternatives to Animal Experimentation  
technology and combining them with microfluidics on a chip.  ...  Traditional in vitro and in silico approaches are not really game changers here, but the substantial investment into novel tools now underway might bring about a second generation of alternative approaches  ...  A key question, then, is whether countermeasures to bioterrorism have a higher likelihood of success in a (theoretical) human trial?  ... 
doi:10.14573/altex.2012.3.251 pmid:22847253 fatcat:wlcopdfy7vf25gjqxnuihofa7e

In silico prediction of cancer immunogens: current state of the art

Irini A. Doytchinova, Darren R. Flower
2018 BMC Immunology  
Here we describe key elements of in silico prediction, including databases of cancer antigens and bleeding-edge methodology for their prediction.  ...  The successful and accurate identification of aberrant host proteins acting as antigens for vaccination and immunotherapy is a key aspiration for both experimental and computational research.  ...  This is currently undergoing a phase I trial in melanoma patients (NCT02410733).  ... 
doi:10.1186/s12865-018-0248-x pmid:29544447 pmcid:PMC5856276 fatcat:dlh6qubumvfofjbnrxxwaafwie

Evaluation framework to guide implementation of AI systems into healthcare settings

Sandeep Reddy, Wendy Rogers, Ville-Petteri Makinen, Enrico Coiera, Pieta Brown, Markus Wenzel, Eva Weicken, Saba Ansari, Piyush Mathur, Aaron Casey, Blair Kelly
2021 BMJ Health & Care Informatics  
TEHAI, because of its strong foundation in translation research models and an emphasis on safety, translational value and generalisability, not only has a theoretical basis but also practical application  ...  To have confidence in the generalisability of AI systems in healthcare and to enable their integration into workflows, there is a need for a practical yet comprehensive instrument to assess the translational  ...  Acknowledgements The authors wish to acknowledge the eight-member international expert panel drawn from various disciplines and organisations of whom Naomi Lee, Kassandra Karpathakis and Jon Herries agreed  ... 
doi:10.1136/bmjhci-2021-100444 pmid:34642177 fatcat:zee6yrgdync4tlq4alciahr3n4

Multi-scale Modeling in Clinical Oncology: Opportunities and Barriers to Success

Thomas E. Yankeelov, Gary An, Oliver Saut, E. Georg Luebeck, Aleksander S. Popel, Benjamin Ribba, Paolo Vicini, Xiaobo Zhou, Jared A. Weis, Kaiming Ye, Guy M. Genin
2016 Annals of Biomedical Engineering  
a potential means of performing in silico clinical trials for both preventative and therapeutic modalities.  ...  Ultimately, these models would form the basis of in silico clinical trials for potential therapeutic regimens, and provide another potential pathway for the design and development of cancer therapeutics  ... 
doi:10.1007/s10439-016-1691-6 pmid:27384942 pmcid:PMC4983505 fatcat:6uo7f3xvifakzfqnwx2c3r4aiu
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