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

Aydin, Burç; Ohmann, Christian

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  "inLanguage": {
    "alternateName": "eng", 
    "@type": "Language", 
    "name": "English"
  "description": "<p>The objective of this deliverable is to define and develop a framework for estimating the impact of in-silico<br>\nmethods and technologies on clinical and preclinical trials, laying the basis for the assessment of<br>\nbroader effects on patient safety, animal welfare and industry workflow. In the introductory part a<br>\nstatus view on this area is given. The document starts with basic terminology and definitions related<br>\nto in-silico approaches. Thereafter, existing standards, guidelines and frameworks relevant for in-silico<br>\ntrials are referenced. Examples and use cases of published in-silico trials are presented as well as<br>\nexisting tools to support in-silico trials described. The introductory part of the deliverable closes with<br>\na selection of projects and programs dedicated to in-silico approaches and relevant for SIMCor.<br>\nThe approach for executing an in-silico trial in SIMCor will be based on the methodology provided by<br>\nBodner and Kaul (Proceedings of the ASME 2021 Verification and Validation Symposium,<br>\nV001T02A0012021) for in-silico clinical trials for medical devices. This framework heavily relies on<br>\nideas already developed for model verification, validation, and uncertainty quantification. The process<br>\nstarts with the computational model, which is developed upstream of the in-silico trial. The next step<br>\nis to establish baseline credibility evidence with the goal that the model is ready to use for the in-silico<br>\ntrial. After this step, clinical trial planning starts with developing the in-silico trial protocol. Thereafter,<br>\nthe in-silico trial is designed as follows: a virtual cohort following the specifications of the human<br>\ncohort is generated and a final model validation will be performed using human data. If the model is<br>\nadequate the model predictions to the target population can be performed and the clinical endpoints<br>\ncan be evaluated. An important aspect in applying in-silico trials is the transfer from engineering<br>\noutputs to clinical endpoints. To support this process, transfer functions based upon available data<br>\nwill be considered in SIMCor.</p>", 
  "license": "", 
  "creator": [
      "affiliation": "ECRIN", 
      "@type": "Person", 
      "name": "Aydin, Bur\u00e7"
      "affiliation": "ECRIN", 
      "@type": "Person", 
      "name": "Ohmann, Christian"
  "url": "", 
  "datePublished": "2021-12-17", 
  "@context": "", 
  "identifier": "", 
  "@id": "", 
  "@type": "CreativeWork", 
  "name": "SIMCor. Deliverable 10.1: In-silico trial impact assessment framework (ECRIN, M12)"
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