Our objectives are of both scientific-technical
and regulatory nature
One objective is to provide a framework and wide approach of in-silico methods (Computer modelling and simulation) where generic and standardized elements can be used for other applications.
The second one aims to demonstrate that such approach can help develop devices and drugs as well as reduce the cost and time to market and to gain the trust of scientists, companies, regulatory bodies, physicians, patients.
The final objective is to impact the whole clinical trials, since this approach can replace some invasive aspects of these trials, and maybe provide novel biomarkers for more accurate clinical trials.
The project considers three realistic scenarios:.
Define model, personalisation & in-silico trial standards, implement demonstrator on European cloud and promote the use of the platform in scientific studies.
Reduce development cost and time-to-market without compromise on efficacy & safety demonstration, gain the trust of regulators for in-silico validity & efficacy and promote European healthcare innovation.
Increase treatment efficacy and patient safety, redesign process of clinical evaluation and gain trust of healthcare providers and patients.
SimCardioTest Challenges
SimCardioTest will challenge today’s huge burden of cardiovascular diseases on the population worldwide with in-silico testing. It has the potential to transform the existing system of clinical trials, while reducing their costs and accelerating the availability of medical drugs/devices. Among other benefits, this testing platform shall demonstrate the possibility to perform experiments in controlled conditions and populations, repeat experiments as often as needed and test therapies for patient-specific pathologies.
SimCardioTest takes the mature field of cardiac simulations, which has previously demonstrated potential in generating clinically-relevant predictions, and brings it further through a web-based platform to perform standardised in-silico trials for testing the efficacy and safety of drugs and devices in the 3 concrete use cases. The first use case is related to the design of cardiac pacing leads, the second use case is based on left atrial appendage occluders (LAAO), and the third use case concerns drug safety and efficacy.
A cloud-based platform
The focus is on building a cloud-based platform where a standardized approach for computer models will be developed. On three use cases provided in this platform, will be demonstrated how these in silico models could non-invasively help in testing devices and drugs. This work will be conducted closely with the regulatory institutions as the output of the simulations can substantially help in supporting the certification process. These simulations will be thoroughly verified, as well as the quantification of uncertainty within the predictions from in-silico simulations.
The Standardisation
The standardisation of all aspects of the in-silico trial platform will facilitate the evaluation of the accuracy and predictive value of the simulation results, thus easing external assessment of the platform by authorities and regulatory bodies. The simulation outputs will also be targeted for regulatory documents thus accelerating the inclusion of in-silico trials in the standard procedures for device and pharmacological tests.
The Validation
Validation in particular from 3 blinded in-silico trials will be set. All aspects of the standardised model input/output and in-silico trial procedure as well as cloud-based solution will be available for evaluation. Novel uncertainty quantification in predictions will add an extra metric to assess confidence in the simulation results. In order to foster trust in clinical and commercial potential of computer models, industry standards in validation, verification and certification of in-silico studies will be set.
Regulations
The involvement in the advisory board of the European medicines agency – EMA, the FDA – Food and drug administration and ESC – European society of cardiology will ensure that efforts will be in line with current regulatory and clinical standards. Improvements in treatment and patient safety resulting from the use cases will provide proof of the effectiveness of the in-silico trial platform in assessing the safety and efficacy of cardiac devices and drugs. Involvement of large and small companies in the development of the standards will contribute to industrial adoption. Finally, broad communication & dissemination of project results towards healthcare professionals and patients by VPHi (ESC, patient groups and associations) will ensure that all users are engaged.
