December 17, 2021 Project deliverable Open Access

Aydin, Burç; Ohmann, Christian

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{
  "publisher": "Zenodo", 
  "DOI": "10.5281/zenodo.6353628", 
  "language": "eng", 
  "title": "SIMCor. Deliverable 10.1: In-silico trial impact assessment framework (ECRIN, M12)", 
  "issued": {
    "date-parts": [
      [
        2021, 
        12, 
        17
      ]
    ]
  }, 
  "abstract": "<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>", 
  "author": [
    {
      "family": "Aydin, Bur\u00e7"
    }, 
    {
      "family": "Ohmann, Christian"
    }
  ], 
  "note": "SIMCor (In-Silico testing and validation of Cardiovascular IMplantable devices) has received funding from the European Union's Horizon 2020 research and innovation programme under grant agreement No 101017578.", 
  "type": "report", 
  "id": "6353628"
}