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Call: Computational models for new patient stratification strategies

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Programme
Acronym HORIZON-HLTH-TOOL
Type of Fund Direct Management
Description of programme
"Horizon Europe - Cluster 1 - Destination 5: Unlocking the full potential of new tools, technologies and digital solutions for a healthy society"

Calls for proposals under this destination are directed towards the Key Strategic Orientation KSO-A ‘Promoting an open strategic autonomy by leading the development of key digital, enabling and emerging technologies, sectors and value chains’ of Horizon Europe’s Strategic Plan 2021-2024. Research and innovation supported under this destination should contribute to the impact area ‘High quality digital services for all’ and in particular to the following expected impact, set out in the Strategic Plan for the health cluster: ‘Health technologies, new tools and digital solutions are applied effectively thanks to their inclusive, secure and ethical development, delivery, integration and deployment in health policies and health and care systems’. In addition, research and innovation supported under this destination could also contribute to the following impact areas: ‘A competitive and secure data-economy’, ‘Industrial leadership in key and emerging technologies that work for people’, and ‘Good health and high-quality accessible health care’.

Technology is a key driver for innovation in the health care sector. It can provide better and more cost-efficient solutions with high societal impact, tailored to the specific health care needs of the individual. However, novel tools, therapies, technologies and digital approaches face specific barriers and hurdles in piloting, implementing and scaling-up before reaching the patient, encountering additional challenges such as public acceptance and trust. Emerging and disruptive technologies offer big opportunities for transforming health care, thereby promoting the health and well-being of citizens. Unlocking this potential and harnessing the opportunities depends on the capacity to collect, integrate and interpret large amounts of data, as well as ensure compatibility with appropriate regulatory frameworks and infrastructures that will both safeguard the rights of the individual and of society and stimulate innovation to develop impactful solutions. In addition to existing European Research Infrastructures, the European Health Data Space will promote health-data exchange and facilitate cross-border research activities. This destination aims to promote the development of tools, technologies and digital solutions for treatments, medicines, medical devices and improved health outcomes, taking into consideration safety, effectiveness, appropriateness, accessibility, comparative value-added and fiscal sustainability as well as issues of ethical, legal and regulatory nature.

In view of increasing the impact of EU investments under Horizon Europe, the European Commission welcomes and supports cooperation between EU-funded projects to enable cross-fertilisation and other synergies. This could range from networking to joint activities such as the participation in joint workshops, the exchange of knowledge, the development and adoption of best practices, or joint communication activities. Opportunities for potential synergies exist between projects funded under the same topic but also between other projects funded under another topic, cluster or pillar of Horizon Europe (but also with ongoing projects funded under Horizon 2020). In particular, this could involve projects related to European health research infrastructures (under pillar I of Horizon Europe), the EIC strategic challenges on health and EIT-KIC Health (under pillar III of Horizon Europe) or in areas cutting across the health and other clusters (under pillar II of Horizon Europe). For instance, with cluster 4 “Digital, Industry and Space” such as on digitalisation of the health sector, incl. health technologies, medical devices and key enabling technologies; assisted, autonomous, independent and empowered living; smart homes; decision support systems; health impact assessment (e.g. related to consumer products, working place innovation).

Expected Impacts

Proposals for topics under this destination should set out a credible pathway towards unlocking the full potential of new tools, technologies and digital solutions for a healthy society, and more specifically to several of the following expected impacts:

  • Europe’s scientific and technological expertise and know-how, its capabilities for innovation in new tools, technologies and digital solutions, and its ability to take-up, scale-up and integrate innovation in health care is world-class.
  • Citizens benefit from targeted and faster research resulting in safer, more efficient, cost-effective and affordable tools, technologies and digital solutions for improved (personalised) disease prevention, diagnosis, treatment and monitoring for better patient outcome and well-being, in particular through increasingly shared health resources (interoperable data, infrastructure, expertise, citizen/patient driven co-creation).[[Commission Communication on the digital transformation of health and care; COM(2018) 233 final.]]
  • The EU gains high visibility and leadership in terms of health technology development, including through international cooperation.
  • The burden of diseases in the EU and worldwide is reduced through the development and integration of innovative diagnostic and therapeutic approaches, personalised medicine approaches, digital and other people-centred solutions for health care.
  • Both the productivity of health research and innovation, and the quality and outcome of health care is improved thanks to the use of health data and innovative analytical tools, such as artificial intelligence (AI) supported decision-making, in a secure and ethical manner, respecting individual integrity and underpinned with public acceptance and trust.

Citizens trust and support the opportunities offered by innovative technologies for health care, based on expected health outcomes and potential risks involved.

Link Link to Programme
Call
Computational models for new patient stratification strategies
Description of call
"Computational models for new patient stratification strategies"

Expected Outcome

  • Clinical researchers use effective health data integration solutions for the classification of the clinical phenotypes.
  • Researchers and/or health care professionals use robust and validated data-driven computational tools to successfully stratify patients.
  • Regulatory bodies approve computer-aided patient stratification strategies to enable personalised diagnosis and/or personalised therapy strategies.
  • Health care professionals adopt evidence-based guidelines for stratification-based patient management superior to the standard-of-care.

Scope:

In the era of big and complex data, the challenge remains to make sense of the huge amount of health care research data. Computational approaches hold great potential to enable superior patient stratification strategies to the established clinical practice, which in turn are a prerequisite for the development of effective personalised medicine approaches.

The proposals may include a broad range of solutions, such as computational disease models, computational systems medicine approaches, machine-learning algorithms, Virtual Physiological Human, digital twin technologies and/or their combinations, as relevant. The topic covers different stages in the continuum of the innovation path (i.e. translational, pre-clinical, clinical research, validation in the clinical and real-world setting, etc.), as relevant to the objectives of the proposals.

The topic will support the development of the computational models driven by the end users' needs.

Proposals should address several of the following areas:

  • Establish interdisciplinary research by bridging disciplines and technologies (disease biology, clinical research, data science, -omics tools, computational and mathematical modelling of diseases, advanced statistical and/or AI/machine learning methods, Virtual Physiological Human and/or digital twin technologies).
  • Develop new computational models for the integration of complex health data from multiples sources, including structured and unstructured data.
  • Develop and optimise robust, transparent and accurate computational models to guide patient stratification strategies for improving clinical outcomes.
  • Demonstrate, test and clinically validate such models with respect to their utility to realistically stratify patients with the aim of improving the standard-of-care.
  • The development of new patient stratification strategies guided by computational models and the validation of the new concepts of stratification in pre-clinical and/or clinical studies.

The proposals should adhere to the FAIR data principles, adopt data quality standards, data integration operating procedures and GDPR-compliant data sharing/access good practices developed by the European research infrastructures, wherever relevant. In addition, proposals are encouraged to adopt good practices of international standards used in the development of computational models, and make available the tools and solutions developed early. Proposals aiming to develop computational models of high technology readiness level are encouraged to deliver a plan for the regulatory acceptability of their technologies. Early interaction with the relevant regulatory bodies is recommended (i.e. the EMA qualification advice for new technologies, etc.) for the proposals contributing to the development of new medicinal products, improvement of the effectiveness of marketed products and the development of medical devices. The proposals aiming to validate their models as high-risk medical devices in the relevant clinical environment are encouraged to deliver a certification implementation plan.

All projects funded under this topic are strongly encouraged to participate in networking and joint activities, as appropriate. These networking and joint activities could, for example, involve the participation in joint workshops, the exchange of knowledge, the development and adoption of best practices, or joint communication activities. This could also involve networking and joint activities with projects funded under other clusters and pillars of Horizon Europe, or other EU programmes, as appropriate. Therefore, proposals are expected to include a budget for the attendance to regular joint meetings and may consider to cover the costs of any other potential joint activities without the prerequisite to detail concrete joint activities at this stage. The details of these joint activities will be defined during the grant agreement preparation phase. In this regard, the Commission may take on the role of facilitator for networking and exchanges, including with relevant stakeholders, if appropriate. In addition, the proposals will be encouraged to exchange with other successful proposals developing AI algorithms and in silico models under other relevant topics.

Link Link to Call
Thematic Focus Clustering, Development Cooperation, Economic Cooperation, Research & Innovation, Technology Transfer & Exchange, Health, Social Affairs, Sports, Capacity Building, Cooperation Networks, Institutional Cooperation
Funding area EU Member States
Overseas Countries and Territories (OCTs)
United States of America
Origin of Applicant EU Member States
Overseas Countries and Territories (OCTs)
United States of America
Eligible applicants Education and Training Centres, Federal State / Region / City / Municipality / Local Authority, Research Institution, Lobby Group / Professional Association / Trade Union, International Organization, Small and Medium Sized Enterprises, SMEs (between 10 and 249 employees), Microenterprises (fewer than 10 employees), NGO / NPO, Public Services, National Government, Other, Start Up Company, University, Enterprise (more than 250 employees or not defined), Association
Applicant details

eligible non-EU countries:

  • countries associated to Horizon Europe
At the date of the publication of the work programme, there are no countries associated to Horizon Europe. Considering the Union’s interest to retain, in principle, relations with the countries associated to Horizon 2020, most third countries associated to Horizon 2020 are expected to be associated to Horizon Europe with an intention to secure uninterrupted continuity between Horizon 2020 and Horizon Europe. In addition, other third countries can also become associated to Horizon Europe during the programme. For the purposes of the eligibility conditions, applicants established in Horizon 2020 Associated Countries or in other third countries negotiating association to Horizon Europe will be treated as entities established in an Associated Country, if the Horizon Europe association agreement with the third country concerned applies at the time of signature of the grant agreement.

  • low-and middle-income countries

Legal entities which are established in countries not listed above will be eligible for funding if provided for in the specific call conditions, or if their participation is considered essential for implementing the action by the granting authority.

Specific cases:

  • Affiliated entities - Affiliated entities are eligible for funding if they are established in one of the countries listed above.
  • EU bodies - Legal entities created under EU law may also be eligible to receive funding, unless their basic act states otherwise.
  • International organisations - International European research organisations are eligible to receive funding. Unless their participation is considered essential for implementing the action by the granting authority, other international organisations are not eligible to receive funding. International organisations with headquarters in a Member State or Associated Country are eligible to receive funding for ‘Training and mobility’actions and when provided for in the specific call conditions.
Project Partner Yes
Project Partner Details

Unless otherwise provided for in the specific call conditions , legal entities forming a consortium are eligible to participate in actions provided that the consortium includes:

  • at least one independent legal entity established in a Member State;and
  • at least two other independent legal entities, each established in different Member States or Associated Countries.
In recognition of the opening of the US National Institutes of Health’s programmes to European researchers, any legal entity established in the United States of America is eligible to receive Union funding to support its participation in projects funded under the Health cluster.
Call opens 06.10.2021
Call closes 21.04.2022
Further info

Proposal page limits and layout:

  • Part A to be filled in directly online  (administrative information, summarised budget, call-specific questions, etc.)
  • Part B to be downloaded from the Portal submission system, completed and re-uploaded as a PDF in the system
This call is subject of a two-stage procedure. In the first stage, applicants will be requested to submit only an outline application.

Page limit - part B: 45 pages - The limit for a first-stage application is 10 pages.
Type of Funding Grants
Financial details
Expected EU contribution per projectThe Commission estimates that an EU contribution of around EUR 6.00 million would allow these outcomes to be addressed appropriately. Nonetheless, this does not preclude submission and selection of a proposal requesting different amounts.
Indicative budgetThe total indicative budget for the topic is EUR 60.00 million.
Typ of ActionResearch and Innovation Actions (RIA)
Funding rate100%
Submission Proposals must be submitted electronically via the Funding & Tenders Portal Electronic Submission System. Paper submissions are NOTpossible.

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