An international consortium of 10 partners has joined forces to demonstrate the feasibility, efficacy and benefits of in silico clinical trials for cardiac devices and drugs.
The ultimate goal is to gain the confidence of scientists, companies, regulators, doctors, patients and to promote innovation in healthcare in Europe and beyond. Simulations corresponding to real measurements will be performed, verified, validated, to quantify uncertainties and help certification, according to international standards. The project also aims to facilitate and encourage the industrial and commercial exploitation of the results.
Six countries are participating in the project: Belgium, Spain, France, Italy, Norway and the United States. The advisory board is composed of the European Medical Agency, the Food and Drug Administration in the United States, Roche, the University of Lyon, Dassault Systèmes and Auckland Bioengineering Institute in New Zealand.
Inria is not only responsible for the overall coordination of SimCardioTest, but is also very involved in the realization of simulations corresponding to real measurements, in order to quantify the realism of the in silico results, and in the development of data science approaches to better exploit the simulation results. More than one million euros of the total funding is allocated to Inria through these 3 research centres.
- Bordeaux Sud-Ouest : Michael Leguèbe and Yves Coudière (also University of Bordeaux)
- Lille - Nord Europe : Christian Duriez
- Sophia Antipolis - Méditerranée : Maxime Sermesant, Hervé Delingette and Marco Lorenzi
The model: a consortium
This type of project set-up requires the involvement of all the partners in the various stages of the project: reflection, contributions, writing, responsibilities. It is essential for Europe that the project does not represent a stack of tasks for the different partners but that, for each of the work units, there is real complementarity and synergy. This can be a challenge, we must manage to build this work organisation so that everyone brings their own brick, while at the same time having strong interactions with the others.
In short, it must be demonstrated that what is obtained in the end, no partner could have done it alone.
It was important, for this type of European call for projects, to have industrialists strongly involved, since we want to show the help that could be given to the design of medical devices and medicines. It is on this basis that companies such as Microport CRM and Boston Scientific and startups such as ExactCure and InSilicoTrials have joined the project.
This represents a fruitful collaboration for both parties. For their part, the startups have already implemented a lot of innovations around this concept but lack specialised content on a key pathology. For our part, and through this European project, we are going to develop content to be able to help the design of cardiac medical devices, and we will need an industrial platform to implement it.
The SimCardioTest project will use previously collected medical data. This was a choice from the very beginning of the project set-up in order to limit the complexity of new data to be acquired and prospective clinical trials. The important thing is to show what we are capable of through numerical simulation, initially on retrospective data.
These data will be pseudonomised and technical security measures are in place to safeguard the rights and freedoms of the data subjects in order to respect the ethical conduct of research imposed by the European Commission (ethical evaluation procedure H2020), and compliance with the General Data Protection Regulation (GDPR).
SimCardioTest will have a significant impact on clinical trials, regulatory systems and healthcare innovation. The project will accelerate the adoption of computer simulations to design new cardiac drugs and medical devices, their translation into the clinic and the market, and increase user confidence (healthcare professionals and patients).
It will allow to:
- review the design of current clinical trials and create a unique, digital and personalised trial environment;
- help reduce the size and duration of human clinical trials and reduce animal testing;
- contribute to increased efficiency and safety for patients in clinical trials;
- reduce the development costs and time-to-market of new medicines and medical devices.
Research is above all a human adventure. It is in collaboration with people that the work is done and progresses.
Coordinator of the European project SimCardioTest
Standardisation and modelling of case studies
The kick-off meeting of the project took place on 25 January, two of our essential actions will be started.
- Standardisation: a standardised approach to simulation and modelling of the core common to all the partners must be put in place so that all the modelling bricks, developed by each one, can communicate with each other in order to be able to implement the different study cases and launch these clinical trials in silico. It is therefore a real effort of interoperability and standardisation that will have to be carried out over the next twelve months.
- Modelling of 3 case studies: cardiac simulation devices (such as pacemakers), a device to prevent strokes (implanted in part of the heart, which tends to generate clots) and drug-related aspects, including their potential toxicity for the heart and their effectiveness.
Each of these case studies will be studied in depth in order to determine the level of detail of what we will have to simulate but also to write the study protocol to be simulated in order to be able to launch these in silico clinical studies afterwards..
Researcher within the Epione project team
2004, route des Lucioles
06902 Sophia Antipolis