Procedure description

Project leader

In SimCardioTest, the ambition is to take the models to the next level. To achieve this, the models will have to be developed to handle the complex medical devices and drugs required in the certification process. As a result, SimCardioTest will have to follow a very strict verification validation and uncertainty qualification, so that the credibility of the models can be established to clearly support the applications to the regulatory bodies.

The verification and uncertainty quantification, to abide by the standards (known as ASME V&V 40) will allow to quantify discretisation error (in time and space), numerical solver error. Uncertainty in model predictions will be compared to actual measurement. And to extend the verification, validation will be implemented according to the ASME V&V 40 standards including risk evaluation as well as certification support for in-silico trials.

This will be realised through meetings with regulatory bodies. The ultimate goal is to initiate new standards in Europe to bridge the gap with the American FDA on simulation and in-silico trials recognition, thanksĀ  to exchange with standardisation bodies and other H2020 projects.

Course of action

  1. Verification that the simulation software is achieving reasonable numerical errors.
  2. Validation of the simulated quantities of interest are realistic enough for the context of use.
  3. Quantification of the uncertainty in the prediction of these quantities of interest.
  4. Assessment of the relevance of EMA / FDA documents related to in-silico modelling for the use cases.
  5. Evaluation of how the in-silico data can contribute to the regulatory process.
  6. Quantification of the difference with existing trial approaches and potential benefits (reduction in cost, time, riskā€¦).
  7. Initiation of discussions towards a novel evaluation system and regulatory framework for in-silico clinical trials.

Video @Inria: Regulatory procdeures for in-silico trials within SimCardioTest