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

Aydin, Burç; Ohmann, Christian

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    <subfield code="a">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.</subfield>
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    <subfield code="a">&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;</subfield>
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