Project deliverable Open Access

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

Aydin, Burç; Ohmann, Christian


JSON Export

{
  "files": [
    {
      "links": {
        "self": "https://zenodo.org/api/files/8e835615-f0c6-4bd6-a4a5-80f87c73d8dc/SIMCor_D10.1_In-silico-clinical-trial-impact-assessment-framework_ECRIN_16-12-2021.pdf"
      }, 
      "checksum": "md5:2aed7fe446d0b0e804e4089a0c10eb45", 
      "bucket": "8e835615-f0c6-4bd6-a4a5-80f87c73d8dc", 
      "key": "SIMCor_D10.1_In-silico-clinical-trial-impact-assessment-framework_ECRIN_16-12-2021.pdf", 
      "type": "pdf", 
      "size": 1225990
    }
  ], 
  "owners": [
    29325
  ], 
  "doi": "10.5281/zenodo.6353628", 
  "stats": {
    "version_unique_downloads": 62.0, 
    "unique_views": 80.0, 
    "views": 88.0, 
    "version_views": 88.0, 
    "unique_downloads": 62.0, 
    "version_unique_views": 80.0, 
    "volume": 98079200.0, 
    "version_downloads": 80.0, 
    "downloads": 80.0, 
    "version_volume": 98079200.0
  }, 
  "links": {
    "doi": "https://doi.org/10.5281/zenodo.6353628", 
    "conceptdoi": "https://doi.org/10.5281/zenodo.6353627", 
    "bucket": "https://zenodo.org/api/files/8e835615-f0c6-4bd6-a4a5-80f87c73d8dc", 
    "conceptbadge": "https://zenodo.org/badge/doi/10.5281/zenodo.6353627.svg", 
    "html": "https://zenodo.org/record/6353628", 
    "latest_html": "https://zenodo.org/record/6353628", 
    "badge": "https://zenodo.org/badge/doi/10.5281/zenodo.6353628.svg", 
    "latest": "https://zenodo.org/api/records/6353628"
  }, 
  "conceptdoi": "10.5281/zenodo.6353627", 
  "created": "2022-03-14T15:06:21.506895+00:00", 
  "updated": "2022-03-16T01:49:32.969402+00:00", 
  "conceptrecid": "6353627", 
  "revision": 2, 
  "id": 6353628, 
  "metadata": {
    "access_right_category": "success", 
    "doi": "10.5281/zenodo.6353628", 
    "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>", 
    "language": "eng", 
    "title": "SIMCor. Deliverable 10.1: In-silico trial impact assessment framework (ECRIN, M12)", 
    "license": {
      "id": "CC-BY-4.0"
    }, 
    "notes": "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.", 
    "relations": {
      "version": [
        {
          "count": 1, 
          "index": 0, 
          "parent": {
            "pid_type": "recid", 
            "pid_value": "6353627"
          }, 
          "is_last": true, 
          "last_child": {
            "pid_type": "recid", 
            "pid_value": "6353628"
          }
        }
      ]
    }, 
    "grants": [
      {
        "code": "101017578", 
        "links": {
          "self": "https://zenodo.org/api/grants/10.13039/501100000780::101017578"
        }, 
        "title": "In Silico testing and validation of Cardiovascular Implantable devices", 
        "acronym": "SIMCOR", 
        "program": "Horizon 2020 Framework Programme - Research and Innovation action", 
        "funder": {
          "doi": "10.13039/501100000780", 
          "acronyms": [], 
          "name": "European Commission", 
          "links": {
            "self": "https://zenodo.org/api/funders/10.13039/501100000780"
          }
        }
      }
    ], 
    "communities": [
      {
        "id": "simcor"
      }
    ], 
    "publication_date": "2021-12-17", 
    "creators": [
      {
        "affiliation": "ECRIN", 
        "name": "Aydin, Bur\u00e7"
      }, 
      {
        "affiliation": "ECRIN", 
        "name": "Ohmann, Christian"
      }
    ], 
    "access_right": "open", 
    "resource_type": {
      "subtype": "deliverable", 
      "type": "publication", 
      "title": "Project deliverable"
    }, 
    "related_identifiers": [
      {
        "scheme": "doi", 
        "identifier": "10.5281/zenodo.6353627", 
        "relation": "isVersionOf"
      }
    ]
  }
}
88
80
views
downloads
All versions This version
Views 8888
Downloads 8080
Data volume 98.1 MB98.1 MB
Unique views 8080
Unique downloads 6262

Share

Cite as