InSilc project develops an in silico clinical trial platform for designing, developing and assessing drug-eluting bioresorbable vascular scaffolds (BVS), by building on the comprehensive biological and biomedical knowledge and advanced modelling approaches to simulate their implantation performance in the individual cardiovascular physiology. The project is funded by the European Commission within the Horizon 2020 Research and Innovation program with € 5.8 M. Twelve partners from ten different countries, including universities, medical centers, research centers and enterprises, participate in the project, providing the necessary experience to ensure the success of the project in all its stages of development.
Participating partners focused their efforts on the smooth implementation of the modelling tasks and the association of the corresponding workflows and results with consistent use-case scenarios and the clinical study design, respectively. In particular, InSilc consortium has started elaborating on the project’s primary objective which is the partial replacement of stent animal and clinical studies by tailored in silico trials. Following some initial discussions with relevant stakeholders, the InSilc consortium established an initial set of “scenarios” upon which the technical workflows and their integration are designed. InSilc is targeting the whole process of the BVS development chain, starting with the pre-clinical testing and the animal testing and next with the real clinical trials. Five different scenarios of use have been developed so far, each of which is focusing on different development phases.
The existence of an inclusive “virtual” population is considered essential for the development of InSilc in silico platform. So far, retrospective clinical data were collected to support the creation of “virtual population”. A prospective proof-of-concept study is also in progress in two countries, Greece and Netherlands.
Reducing the size and the duration of the human clinical trials. A more effective human clinical trials design.
A number of papers as well as international guidelines have identified standard clinical and imaging endpoints which are evaluated in clinical trials with BVS. Most clinical outcomes are influenced by several factors, such as plaque composition, atherosclerotic burden, patient characteristics and comorbidities and require large number of patients to be adequately assessed.
Moreover, clinical endpoints may require long observation periods to be detected. InSilc is expected to potentiate these early phases trials by the utilization of the InSilc multidisciplinary models, which identify and classify the patients based on specific characteristics and provide information regarding the performance of the drug-eluting BVS and the patients who are at a higher risk for complications.
The benefits of InSilc “virtual population”.
The creation of the InSilc “virtual” population and the utilization of the simulated patients (“virtual scenarios”) fill the gaps in the individual variability of the “real patients” allowing to detect potential issues or potential benefit much earlier in the development process. In addition, the data from the ““virtual” patients are used as “prior knowledge” for designing an adaptive clinical trial, where the clinical endpoint is evaluated with a combination of the data from the real and “virtual” patients.
Lower development costs and/or shorter time-to-market for new medical products. Improving prediction of human risks for new biomedical products.
The coronary stents market is a vast and dynamic market that is saturated with numerous players in Europe and worldwide. This competitive landscape includes large, mid-size, and small companies, which have developed different types of coronary stents targeting a variety of indications, such as de novo lesions and bifurcation lesions. Among the stent designs available are drug-eluting BVS. Drug-eluting BVS have an advantage compared to traditional metal drug-eluting stents, which leave a permanent metal scaffold within the lumen of the blood vessel, but have been associated with high development costs and a longer time to reach the market. Use of the InSilc platform during the early stages of the product development cycle could lower the development costs and decrease time to market of truly innovative and effective drug-eluting BVS. In addition, use of the InSilc platform could significantly reduce the risk of device redesign, and the significant costs associated with it, later in the product development.