The aim of the call is to fund research projects that validate existing predictive computational models using biomedical data to expand the knowledge about human diseases and their treatment.

Project proposals submitted under this call must focus on the analysis, interpretation and application of different biological and clinical data by appropriate computational models. Projects have to demonstrate the practical relevance of computational models for medical routine and their benefit for individual patients. As an example, the knowledge gained may help to enable drug repurposing across different diseases.

To fit the aim of the call projects must focus on one of the two following approaches. Projects must validate clinically relevant computational models already existing and their predictions using biomedical and/or clinical data by stepwise expansion and improvement through repeated cycles of data-driven modelling and model-based experimentation. Alternatively, projects must discover and validate common molecular mechanisms underlying at least two different diseases using appropriate computational modelling approaches allowing a re-definition of clinical phenotypes and improvement of patient stratification for clinical trials.

As prerequisite for funding, each project must meet the following conditions:

• A multidisciplinary collaboration of clinicians, experimentalists, computational scientists, bioinformaticians, data management and curation experts, industrial partners and if possible, patient communities is expected. Each consortium must include at least one clinical group and a computational modelling group.
• The project must apply a systems medicine approach.
• Relevant patient data sets and patient samples, and well annotated archived samples should be available. New data may only be generated when it is necessary for the modelling cycle, therefore generation of new data cannot be a major part of the project. Patient recruitment should be completed at the time of application.
• Computational models based on high-quality datasets (sufficient deep phenotyping, curated data sets) should already exist.
• Clinical centers providing patients and their data should give evidence of the ethical and legal clearance for data sharing, patient consent for using the data for the purpose of the proposed project if applicable, as well as their data quality and suitability for computational analysis.
• A data management plan and data handling protocols according to international state-of-the-art standards (FAIR[1]and GDPR[2] compliant and secure) must be provided as an integral part of the application. A data management plan should address criteria such as data accessibility, format and storage, stewardship/curation, time plan and schedule for the submission date, quality of meta data, and data security. For this, it may help to follow the guiding questions found in the data management plan (DMP) template in Horizon 2020[3]. Data storage, data/model exchange and data/model sharing agreements should be available at the time of application.
• The use of existing infrastructures (e.g. ELIXIR) should be taken into consideration.
• The application must contain a plan for involvement of different stakeholders. This plan describes how, why and when stakeholder involvement will be handled. Furthermore, it must describe how the project will benefit from the inclusion of the stakeholder(s). The benefit can e.g. be to develop a product the end-users need or welcome, to decrease financial burden on health care providers, or to facilitate public debate of the research. Stakeholders can be patients, health care providers, public bodies, medical professionals, companies, etc.
• Applications must fulfil the national ethical and legal requirements. For instance, among other things, special attention must be paid to ethical issues (e.g. research on humans or animals; privacy of data and biomaterials; informed consent; etc.).Please be aware that regulations and ethical issues vary among different countries and should be considered from the outset.

Info session

On Monday, 14 January 2019, the FNR hosted an info session to inform about multilateral Calls in the biomedical domain, supported by the FNR via the INTER programme.

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General conditions for application

Joint research proposals may be submitted by higher education institutions, non-university public research establishments, hospitals as well as commercial companies, in particular small and medium-size enterprises (SMEs), according to relevant national funding regulations. Whilst applications will be submitted jointly by groups from several countries, individual groups will be funded by the individual ERACoSysMed funding organization respective of the country from which applicants have applied. The applications are therefore subjected to eligibility criteria of individual funding organizations. Applicants are strongly advised to contact their national representative and confirm eligibility with their respective funding organizations in advance of submitting an application.

Only transnational projects will be funded. Each consortium must involve a minimum of three and a maximum of five eligible partners from at least three different countries participating to the call (see list above). For reasons of transnational balance, in this call no more than two eligible partners from the same country are allowed to join each consortium. External collaborators, i.e. groups from countries that are not participating in this call, or research groups from countries that are partners in this joint transnational call but do not ask for funding, may participate in projects, provided that they demonstrate in advance that their economic and human resources have already been secured and will be available at the start of the project. The maximum number of external collaborators per consortium is two. In order to strengthen the implementation of Systems Medicine throughout Europe, the inclusion of research teams from Slovakia is encouraged. Therefore, consortia including partners from Slovakia may increase the maximum number of eligible partners to eight (five eligible partners + two external collaborators + an additional partner from Slovakia).

Each transnational collaborative project should represent the critical mass to achieve the scientific goals, the translation of Systems Medicine approaches into medical research and practice, and to clearly demonstrate an added value from working together. Clinical expertise is mandatory in order to ensure an efficient transfer of results into clinical application.