Computational models for new patient stratification strategies
HORIZON Research and Innovation Actions
Basic Information
- Identifier
- HORIZON-HLTH-2022-TOOL-12-01-two-stage
- Programme
- Tools and technologies for a healthy society (two-stages - 2022)
- Programme Period
- 2021 - 2027
- Status
- Closed (31094503)
- Opening Date
- October 5, 2021
- Deadline
- January 31, 2022
- Deadline Model
- two-stage
- Budget
- €60,000,000
- Min Grant Amount
- €6,000,000
- Max Grant Amount
- €6,000,000
- Expected Number of Grants
- 10
- Keywords
- HORIZON-HLTH-2022-TOOL-12-01-two-stageHORIZON-HLTH-2022-TOOL-12-two-stageComputational modellingPatient stratificationSimulation engineering and modelling
Description
This topic aims at supporting activities that are enabling or contributing to one or several expected impacts of destination 5 “Unlocking the full potential of new tools, technologies and digital solutions for a healthy society”. To that end, proposals under this topic should aim for delivering results that are directed, tailored and contributing to some of the following expected outcomes:
- 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.
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[1] 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.
[1] FAIR data are data, which meet principles of findability, accessibility, interoperability, and reusability.
Destination & Scope
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).[1]
- 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.
[1] Commission Communication on the digital transformation of health and care; COM(2018) 233 final.
Eligibility & Conditions
General conditions
2. Eligible countries: described in Annex B of the Work Programme General Annexes.
A number of non-EU/non-Associated Countries that are not automatically eligible for funding have made specific provisions for making funding available for their participants in Horizon Europe projects. See the information in the Horizon Europe Programme Guide.
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.
3. Other eligibility conditions: described in Annex B of the Work Programme General Annexes.
4. Financial and operational capacity and exclusion: described in Annex C of the Work Programme General Annexes.
Award criteria, scoring and thresholds are described in Annex D of the Work Programme General Annexes.
Submission and evaluation processes are described in Annex F of the Work Programme General Annexes and the Online Manual.
Indicative timeline for evaluation and grant agreement: described in Annex F of the Work Programme General Annexes.
6. Legal and financial set-up of the grants: described in Annex G of the Work Programme General Annexes.
Specific conditions
7. Specific conditions: described in the specific topic of the Work Programme.
Documents
Call documents:
Standard application form (HE RIA, IA) — call-specific application form is available in the Submission System
Standard application form (HE RIA, IA Stage 1) — call-specific application form is available in the Submission System
Standard evaluation form (HE RIA, IA) — will be used with the necessary adaptations
Standard evaluation form (HE RIA, IA Stage 1) — will be used with the necessary adaptations
HE General MGA v1.0
Essential Information for Clinical Studies
Additional documents:
HE Main Work Programme 2021–2022 – 1. General Introduction
HE Main Work Programme 2021–2022 – 4. Health
HE Main Work Programme 2021–2022 – 13. General Annexes
HE Programme Guide
EU Financial Regulation
Rules for Legal Entity Validation, LEAR Appointment and Financial Capacity Assessment
EU Grants AGA — Annotated Model Grant Agreement
Funding & Tenders Portal Online Manual
Funding & Tenders Portal Terms and Conditions
Funding & Tenders Portal Privacy Statement
Support & Resources
Online Manual is your guide on the procedures from proposal submission to managing your grant.
Horizon Europe Programme Guidecontains the detailed guidance to the structure, budget and political priorities of Horizon Europe.
Funding & Tenders Portal FAQ – find the answers to most frequently asked questions on submission of proposals, evaluation and grant management.
Research Enquiry Service – ask questions about any aspect of European research in general and the EU Research Framework Programmes in particular.
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The European Charter for Researchers and the Code of Conduct for their recruitment– consult the general principles and requirements specifying the roles, responsibilities and entitlements of researchers, employers and funders of researchers.
Partner Search Services help you find a partner organisation for your proposal.
National Contact Points (NCP) – contact your NCP for further assistance.
Latest Updates
We recently informed the applicants about the evaluation results for their proposals submitted under this topic. The results of the evaluation are as follows:
- Number of proposals submitted (including proposals transferred from or to other calls): 31
- Number of inadmissible proposals: 0
- Number of ineligible proposals: 0
- Number of above-threshold proposals: 22
- Total budget requested for above-threshold proposals: 139.013.205,25 EUR
Second stage of call HORIZON-HLTH-2022-TOOL-12-two-stage closed on 6 September 2022. 31 proposals have been submitted under topic HORIZON-HLTH-2022-TOOL-12-01-two-stage.
Evaluation results are expected to be communicated on Friday 9 December 2022 at the earliest.
Second stage of call HORIZON-HLTH-2022-TOOL-12-two-stage closed on 6 September 2022. 31 proposals have been submitted under topic HORIZON-HLTH-2022-TOOL-12-01-two-stage.
Evaluation results are expected to be communicated on Friday 9 December 2022 at the earliest.
In order to best ensure equal treatment, successful stage 1 applicants do not receive the evaluation summary reports (ESRs) for their proposals, but this generalised feedback with information and tips for preparing the full proposal.
Information & tips
Main suggestions to stage 2 applicants:
- The proposal should address all the individual sub-criteria under in the appropriate section of the proposal. The methodology, current state of the art and – where relevant – use of AI should be clearly described.
- The quality of data and standards should be emphasised.
- If your proposal contains clinical studies, please read carefully the definition and guidance on the template ‘Information on clinical studies' published on the call page in the Participant Portal (https://ec.europa.eu/info/funding-tenders/opportunities/docs/2021-2027/horizon/temp-form/af/information-on-clinical-studies_he_en.docx) and remember to upload the template filled in when submitting your proposal.
In your stage 2 proposal, you have a chance to address or clarify these issues. Please bear in mind that your full proposal will now be evaluated more in-depth and possibly by a new group of outside experts.
Please make sure that your full proposal is consistent with your short outline proposal. It may NOT differ substantially. The project must remain the same.
Please consult the "Call updates" section for generalised feedback after stage 1.
Evaluation results for the second stage are expected to be communicated on Friday 9 December 2022 at the earliest.
Evaluation results for the second stage are expected to be communicated on Friday 9 December 2022 at the earliest.
In accordance with General Annex D of the Work Programme, the evaluation of the first-stage proposals was made looking only at the criteria 'excellence' and 'impact'. The threshold for both individual criteria is 4.
The overall threshold applying to the sum of the two individual scores was set at a level that ensures the total requested budget of proposals admitted to stage 2 is as close as possible to three times the available budget, and not less than two and a half times the available budget, and is as follows:
- HORIZON-HLTH-2022-TOOL-12-01-two-stage: Overall threshold applied is 9,0
The results of the evaluation are:
- Number of proposals submitted (including proposals transferred from or to other calls): 154
- Number of inadmissible proposals: 0
- Number of ineligible proposals: 0
- Number of above-threshold proposals: 32
- Total budget requested for above-threshold proposals: EUR 190.249.663,55
In accordance with General Annex D of the Work Programme, the evaluation of the first-stage proposals was made looking only at the criteria 'excellence' and 'impact'. The threshold for both individual criteria is 4.
The overall threshold applying to the sum of the two individual scores was set at a level that ensures the total requested budget of proposals admitted to stage 2 is as close as possible to three times the available budget, and not less than two and a half times the available budget, and is as follows:
- HORIZON-HLTH-2022-TOOL-12-01-two-stage: Overall threshold applied is 9,0
The results of the evaluation are:
- Number of proposals submitted (including proposals transferred from or to other calls): 154
- Number of inadmissible proposals: 0
- Number of ineligible proposals: 0
- Number of above-threshold proposals: 32
- Total budget requested for above-threshold proposals: EUR 190.249.663,55
Call HORIZON-HLTH-2022-TOOL-12-two-stage closed on 1 February 2022. 154 proposals have been submitted. The breakdown per topic is:
- HORIZON-HLTH-2022-TOOL-12-01-two-stage: 154 proposals
Evaluation results are expected to be communicated on Friday 20 May 2022 at the earliest.
Call HORIZON-HLTH-2022-TOOL-12-two-stage closed on 1 February 2022. 154 proposals have been submitted. The breakdown per topic is:
- HORIZON-HLTH-2022-TOOL-12-01-two-stage: 154 proposals
Evaluation results are expected to be communicated on Friday 20 May 2022 at the earliest.