Project deliverable Open Access

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

Aydin, Burç; Ohmann, Christian


DCAT Export

<?xml version='1.0' encoding='utf-8'?>
<rdf:RDF xmlns:rdf="http://www.w3.org/1999/02/22-rdf-syntax-ns#" xmlns:adms="http://www.w3.org/ns/adms#" xmlns:dc="http://purl.org/dc/elements/1.1/" xmlns:dct="http://purl.org/dc/terms/" xmlns:dctype="http://purl.org/dc/dcmitype/" xmlns:dcat="http://www.w3.org/ns/dcat#" xmlns:duv="http://www.w3.org/ns/duv#" xmlns:foaf="http://xmlns.com/foaf/0.1/" xmlns:frapo="http://purl.org/cerif/frapo/" xmlns:geo="http://www.w3.org/2003/01/geo/wgs84_pos#" xmlns:gsp="http://www.opengis.net/ont/geosparql#" xmlns:locn="http://www.w3.org/ns/locn#" xmlns:org="http://www.w3.org/ns/org#" xmlns:owl="http://www.w3.org/2002/07/owl#" xmlns:prov="http://www.w3.org/ns/prov#" xmlns:rdfs="http://www.w3.org/2000/01/rdf-schema#" xmlns:schema="http://schema.org/" xmlns:skos="http://www.w3.org/2004/02/skos/core#" xmlns:vcard="http://www.w3.org/2006/vcard/ns#" xmlns:wdrs="http://www.w3.org/2007/05/powder-s#">
  <rdf:Description rdf:about="https://doi.org/10.5281/zenodo.6353628">
    <rdf:type rdf:resource="http://www.w3.org/ns/dcat#Dataset"/>
    <dct:type rdf:resource="http://purl.org/dc/dcmitype/Text"/>
    <dct:identifier rdf:datatype="http://www.w3.org/2001/XMLSchema#anyURI">https://doi.org/10.5281/zenodo.6353628</dct:identifier>
    <foaf:page rdf:resource="https://doi.org/10.5281/zenodo.6353628"/>
    <dct:creator>
      <rdf:Description>
        <rdf:type rdf:resource="http://xmlns.com/foaf/0.1/Agent"/>
        <foaf:name>Aydin, Burç</foaf:name>
        <foaf:givenName>Burç</foaf:givenName>
        <foaf:familyName>Aydin</foaf:familyName>
        <org:memberOf>
          <foaf:Organization>
            <foaf:name>ECRIN</foaf:name>
          </foaf:Organization>
        </org:memberOf>
      </rdf:Description>
    </dct:creator>
    <dct:creator>
      <rdf:Description>
        <rdf:type rdf:resource="http://xmlns.com/foaf/0.1/Agent"/>
        <foaf:name>Ohmann, Christian</foaf:name>
        <foaf:givenName>Christian</foaf:givenName>
        <foaf:familyName>Ohmann</foaf:familyName>
        <org:memberOf>
          <foaf:Organization>
            <foaf:name>ECRIN</foaf:name>
          </foaf:Organization>
        </org:memberOf>
      </rdf:Description>
    </dct:creator>
    <dct:title>SIMCor. Deliverable 10.1: In-silico trial impact assessment framework (ECRIN, M12)</dct:title>
    <dct:publisher>
      <foaf:Agent>
        <foaf:name>Zenodo</foaf:name>
      </foaf:Agent>
    </dct:publisher>
    <dct:issued rdf:datatype="http://www.w3.org/2001/XMLSchema#gYear">2021</dct:issued>
    <frapo:isFundedBy rdf:resource="info:eu-repo/grantAgreement/EC/Horizon 2020 Framework Programme - Research and Innovation action/101017578/"/>
    <schema:funder>
      <foaf:Organization>
        <dct:identifier rdf:datatype="http://www.w3.org/2001/XMLSchema#string">10.13039/100010661</dct:identifier>
        <foaf:name>European Commission</foaf:name>
      </foaf:Organization>
    </schema:funder>
    <dct:issued rdf:datatype="http://www.w3.org/2001/XMLSchema#date">2021-12-17</dct:issued>
    <dct:language rdf:resource="http://publications.europa.eu/resource/authority/language/ENG"/>
    <owl:sameAs rdf:resource="https://zenodo.org/record/6353628"/>
    <adms:identifier>
      <adms:Identifier>
        <skos:notation rdf:datatype="http://www.w3.org/2001/XMLSchema#anyURI">https://zenodo.org/record/6353628</skos:notation>
        <adms:schemeAgency>url</adms:schemeAgency>
      </adms:Identifier>
    </adms:identifier>
    <dct:isVersionOf rdf:resource="https://doi.org/10.5281/zenodo.6353627"/>
    <dct:isPartOf rdf:resource="https://zenodo.org/communities/simcor"/>
    <dct:description>&lt;p&gt;The objective of this deliverable is to define and develop a framework for estimating the impact of in-silico&lt;br&gt; methods and technologies on clinical and preclinical trials, laying the basis for the assessment of&lt;br&gt; broader effects on patient safety, animal welfare and industry workflow. In the introductory part a&lt;br&gt; status view on this area is given. The document starts with basic terminology and definitions related&lt;br&gt; to in-silico approaches. Thereafter, existing standards, guidelines and frameworks relevant for in-silico&lt;br&gt; trials are referenced. Examples and use cases of published in-silico trials are presented as well as&lt;br&gt; existing tools to support in-silico trials described. The introductory part of the deliverable closes with&lt;br&gt; a selection of projects and programs dedicated to in-silico approaches and relevant for SIMCor.&lt;br&gt; The approach for executing an in-silico trial in SIMCor will be based on the methodology provided by&lt;br&gt; Bodner and Kaul (Proceedings of the ASME 2021 Verification and Validation Symposium,&lt;br&gt; V001T02A0012021) for in-silico clinical trials for medical devices. This framework heavily relies on&lt;br&gt; ideas already developed for model verification, validation, and uncertainty quantification. The process&lt;br&gt; starts with the computational model, which is developed upstream of the in-silico trial. The next step&lt;br&gt; is to establish baseline credibility evidence with the goal that the model is ready to use for the in-silico&lt;br&gt; trial. After this step, clinical trial planning starts with developing the in-silico trial protocol. Thereafter,&lt;br&gt; the in-silico trial is designed as follows: a virtual cohort following the specifications of the human&lt;br&gt; cohort is generated and a final model validation will be performed using human data. If the model is&lt;br&gt; adequate the model predictions to the target population can be performed and the clinical endpoints&lt;br&gt; can be evaluated. An important aspect in applying in-silico trials is the transfer from engineering&lt;br&gt; outputs to clinical endpoints. To support this process, transfer functions based upon available data&lt;br&gt; will be considered in SIMCor.&lt;/p&gt;</dct:description>
    <dct:description>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.</dct:description>
    <dct:accessRights rdf:resource="http://publications.europa.eu/resource/authority/access-right/PUBLIC"/>
    <dct:accessRights>
      <dct:RightsStatement rdf:about="info:eu-repo/semantics/openAccess">
        <rdfs:label>Open Access</rdfs:label>
      </dct:RightsStatement>
    </dct:accessRights>
    <dcat:distribution>
      <dcat:Distribution>
        <dct:license rdf:resource="https://creativecommons.org/licenses/by/4.0/legalcode"/>
        <dcat:accessURL rdf:resource="https://doi.org/10.5281/zenodo.6353628"/>
      </dcat:Distribution>
    </dcat:distribution>
    <dcat:distribution>
      <dcat:Distribution>
        <dcat:accessURL rdf:resource="https://doi.org/10.5281/zenodo.6353628"/>
        <dcat:byteSize>1225990</dcat:byteSize>
        <dcat:downloadURL rdf:resource="https://zenodo.org/record/6353628/files/SIMCor_D10.1_In-silico-clinical-trial-impact-assessment-framework_ECRIN_16-12-2021.pdf"/>
        <dcat:mediaType>application/pdf</dcat:mediaType>
      </dcat:Distribution>
    </dcat:distribution>
  </rdf:Description>
  <foaf:Project rdf:about="info:eu-repo/grantAgreement/EC/Horizon 2020 Framework Programme - Research and Innovation action/101017578/">
    <dct:identifier rdf:datatype="http://www.w3.org/2001/XMLSchema#string">101017578</dct:identifier>
    <dct:title>In Silico testing and validation of Cardiovascular Implantable devices</dct:title>
    <frapo:isAwardedBy>
      <foaf:Organization>
        <dct:identifier rdf:datatype="http://www.w3.org/2001/XMLSchema#string">10.13039/100010661</dct:identifier>
        <foaf:name>European Commission</foaf:name>
      </foaf:Organization>
    </frapo:isAwardedBy>
  </foaf:Project>
</rdf:RDF>
87
79
views
downloads
All versions This version
Views 8787
Downloads 7979
Data volume 96.9 MB96.9 MB
Unique views 7979
Unique downloads 6161

Share

Cite as