Closed

Comparative effectiveness research for healthcare interventions in areas of high public health need

HORIZON Research and Innovation Actions

Basic Information

Identifier
HORIZON-HLTH-2024-DISEASE-03-08-two-stage
Programme
Tackling diseases (Two stage - 2024)
Programme Period
2021 - 2027
Status
Closed (31094503)
Opening Date
April 25, 2023
Deadline
September 18, 2023
Deadline Model
two-stage
Budget
€25,000,000
Min Grant Amount
€6,000,000
Max Grant Amount
€7,000,000
Expected Number of Grants
4
Keywords
HORIZON-HLTH-2024-DISEASE-03-08-two-stageHORIZON-HLTH-2024-DISEASE-03-two-stageClinical researchClinical trialsHealth policiesHealth policy and servicesHealth services, health care researchPersonalised interventionsQuality of health careWellbeing

Description

Expected Outcome:

This topic aims at supporting activities that are enabling or contributing to one or several expected impacts of destination 3 “Tackling diseases and reducing disease burden”. To that end, proposals under this topic should aim for delivering results that are directed, tailored towards and contributing to most of the following expected outcomes:

  • Health policymakers are aware of the healthcare interventions (pharmacological, non-pharmacological or technological interventions; including preventive and rehabilitative actions) that are identified as working best for the specific population groups from the point of view of safety, efficacy, patient outcomes, adherence, quality of life, accessibility, and (cost-) effectiveness.
  • Health professionals have access to and use the improved clinical guidelines on the optimal treatment of patients and prevention of diseases e.g. through vaccines. Considerations made in the guidelines include the harmonisation and standardisation of care for high burden diseases or conditions throughout Europe, as well as possible individualised needs of patients.
  • The scientific and clinical communities make effective use of state-of-the-art information, data, technologies, tools and best practices to develop interventions that are sustainable.
  • Citizens, patients, prescribers, and payers receive more accurate information on available healthcare interventions via ad hoc communication platforms.
  • The scientific and clinical communities make wide use of the newly established open access databases and/or integrate them with existing open access infrastructures for storage and sharing of collected data according to FAIR[1] principles.
Scope:

Effective, affordable and accessible healthcare for diverse population groups is challenging and complex. For example, specific needs underlie the delivery of effective preventive actions and therapeutic treatments to a rapidly growing elderly population, often presenting comorbidities and associated polypharmacy. The paediatric population, including children born preterm, has also its specific needs in specially adjusted therapeutics and early interventions to address emerging health and developmental problems. Similar to the elderly population, the paediatric population is often excluded from many clinical trials that generate the evidence base for healthcare interventions. Women, including pregnant women, are also often under-represented in clinical studies and access to quality healthcare is frequently inadequate. Other population groups with limited access to quality healthcare and/or under-representation in clinical studies include low-income groups, and refugees. Intersectionality within these groups also needs consideration.

Proposals should address most of the following:

  • Compare the use of currently existing (pharmacological, non-pharmacological and technological) healthcare interventions in specific population groups (or selected subgroups). While there is no restriction on diseases or conditions, preference will be given to proposals focusing on interventions with high public health relevance[2].
  • Ensure acceptability and sustainability of the healthcare intervention through early involvement of ‘end users’ (e.g. patients, care providers) in the design of the study (integrating patient valued outcomes) and, where possible, in the research process including implementation. Additionally, proposals should take into account the diversity of health systems in different regions of Europe to allow large-scale uptake.
  • Consider involving HTA bodies in order to create synergies and accelerate the practical implementation of the results. Where relevant, existing work of EU-funded projects such as EUnetHTA[3] should be also taken into account.
  • Consider issues of particular relevance for the target populations, for example, multimorbidity, complex chronic conditions, polypharmacy, substance misuse, vaccine efficacy, compliance, age, gender specificities and diseases with high societal burden (including but not limited to e.g. musculoskeletal diseases and mental health disorders). Special consideration should be given to fulfilling all ethical requirements.
  • For the chosen population, assess clinical and safety parameters, as well as health and socio-economic outcomes (e.g. quality of life, patient mortality, (co)morbidity, costs, and performance of the health system). Agreed core outcome sets (COS) should be used as endpoints in conditions where they already exist, in other cases, efforts should be made to agree on such COS. Consider using new instruments and methods for determining the burden of disease and for evaluating the effects of the interventions. Low-cost innovations should also be considered.
  • Inclusion of patient organisations and associations of caregivers and other healthcare professionals is recommended.
  • Clinical trials, including pragmatic clinical trials, observational studies, use of existing health data in different study designs, creation of large-scale databases and performing meta-analyses may be considered for this topic. Use of existing data should always be considered to add value, increase quality and increase implementation speed of the study. Regarding databases, sustainability after the proposed action's end also needs to be considered.
  • The proposed research needs to take into account sex and gender aspects.

This topic requires the effective contribution of social sciences and humanities (SSH) disciplines and the involvement of SSH experts, institutions as well as the inclusion of relevant SSH expertise, in order to produce meaningful and significant effects enhancing the societal impact of the related research activities.

The Commission will ensure an overall coordination mechanism between the projects funded under this topic to catalyse the exchange of knowledge, as well as the development and adoption of best practices. Proposals are expected to budget for the attendance to regular meetings. Projects resulting from this call will be invited to share and discuss their case studies amongst themselves and with relevant stakeholders at the EU level, and necessary resources should be allocated to this task.

Applicants invited to the second stage and envisaging to include clinical studies should provide details of their clinical studies in the dedicated annex using the template provided in the submission system. See definition of clinical studies in the introduction to this work programme part.

[1] See definition of FAIR data in the introduction to this work programme part.

[2] Interventions addressing diseases or conditions that are particularly frequent, have a high negative impact on the quality of life of the individual and/or are associated with significant costs where savings can be achieved.

[3] https://www.eunethta.eu/

Destination & Scope

Calls for proposals under this destination are directed towards the Key Strategic Orientation KSO-D ‘Creating a more resilient, inclusive and democratic European society’ of Horizon Europe’s Strategic Plan 2021-2024. Research and innovation supported under this destination should contribute to the impact area ‘Good health and high-quality accessible healthcare’ and in particular to the following expected impact, set out in the Strategic Plan for the health cluster: ‘health care providers are able to better tackle and manage diseases (infectious diseases, including poverty-related and neglected diseases, non-communicable and rare diseases) and reduce the disease burden on patients effectively thanks to better understanding and treatment of diseases, more effective and innovative health technologies, better ability and preparedness to manage epidemic outbreaks and improved patient safety’. In addition, research and innovation supported under this destination could also contribute to the following impact areas: ‘A resilient EU prepared for emerging threats’, ‘Climate change mitigation and adaptation’, and ‘High quality digital services for all’.

Communicable and non-communicable diseases cause the greatest amounts of premature death and disability in the EU and worldwide. They pose a major health, societal and economic threat and burden. Many people are still suffering from these diseases and too often dying prematurely. Non-communicable diseases, including mental illnesses and neurodegenerative diseases, are responsible for up to 80% of EU health care costs[1]. These costs are spent on the treatment of such diseases that to a large extent are preventable. Furthermore, only around 3% of the health care budgets are currently spent on preventive measures although there is a huge potential for prevention. Infectious diseases, including emerging infectious diseases and infections resistant to antimicrobials, remain a major threat to public health in the EU but also to global health security. Deaths caused by antimicrobial resistance (AMR) could exceed 10 million per year worldwide according to some predictions[2].

To further advance, there is an urgent need for research and innovation to develop new preparedness and prevention measures, public health interventions, diagnostics, vaccines, therapies, alternatives to antimicrobials, as well as to improve existing preparedness and prevention strategies to create tangible impacts, taking into account sex/gender-related issues. This will require international cooperation to pool the best expertise and know-how available worldwide, to access world-class research infrastructures and to leverage critical scales of investments on priority needs through a better alignment with other funders of international cooperation in health research and innovation. The continuation of international partnerships and cooperation with international organisations is particularly needed to combat infectious diseases, to address antimicrobial resistances, to respond to major unmet medical needs for global health security, including the global burden of non-communicable diseases, and to strengthen patient safety.

In this work programme, destination 3 will focus on major societal challenges linked to the Commission’s political priorities such as the fight against cancer and other non-communicable diseases, better diagnosis and treatment of rare diseases, preparedness and response to and surveillance of health threats and epidemics, reduction of the number of antimicrobial-resistant infections, improving vaccination rates, demographic change, mental health and digital empowerment in health literacy. In particular, the topics under this destination will support activities aiming at: i) better understanding of diseases, their drivers and consequences, including pain and the causative links between health determinants and diseases, and better evidence-base for policymaking; ii) better methodologies and diagnostics that allow timely and accurate diagnosis, identification of personalised treatment options and assessment of health outcomes, including for patients with a rare disease; iii) development and validation of effective intervention for better surveillance, prevention, detection, treatment and crisis management of infectious disease threats; iv) innovative health technologies developed and tested in clinical practice, including personalised medicine approaches and use of digital tools to optimise clinical workflows; v) new and advanced therapies for non-communicable diseases, including rare diseases developed in particular for those without approved options, supported by strategies to make them affordable for the public payer; and vi) scientific evidence for improved/tailored policies and legal frameworks and to inform major policy initiatives at global level (e.g. WHO Framework Convention on Tobacco Control; UNEA Pollution Implementation Plan).

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 3 “Civil security for society” such as on health security/emergencies (preparedness and response, medical countermeasures, epidemic outbreaks/pandemics, natural disasters and technological incidents, bioterrorism); with cluster 4 “Digital, Industry and Space” such as on decision-support systems or on geo-observation and monitoring (e.g. of disease vectors, epidemics); or with cluster 6 “Food, bioeconomy, natural resources, agriculture and environment” such as on health security and AMR (one-health: human/animal/plant/soil/water health). In addition, while focusing on civilian applications, there may be there may be synergies with actions conducted under the European Defence Fund, notably in the field of defence medical countermeasures.

Based on needs that emerged during the management of COVID-19, some research and innovation actions under Destination 3 should support the mission of the European Health Emergency and Response Authority (HERA) to strengthen Europe’s ability to prevent, detect, and rapidly respond to cross-border health emergencies by ensuring the availability and access to key medical countermeasures. Other actions should deliver relevant complementary inputs to the “Europe’s Beating Cancer Plan”[3] in order to cover the entire cancer care pathway, including prevention, early detection, diagnosis, treatment, cancer data monitoring, as well as quality of life of cancer patients and survivors. Furthermore, synergies and complementarities will be sought between Destination 3 and the implementation of the EU4Health Programme (2021-2027)[4]. These synergies and complementarities could be achieved, notably through mechanisms based on feedback loops, enabling on the one hand to identify policy needs that should be prioritised in research and innovation actions and facilitating on the other hand the implementation of research results into policy actions and clinical practice, thereby providing an integrated response across sectors and policy fields.

Expected impacts:

Proposals for topics under this destination should set out a credible pathway to contributing to tackling diseases and reducing disease burden, and more specifically to several of the following impacts:

  • Health burden of diseases in the EU and worldwide is reduced through effective disease management, including through the development and integration of innovative diagnostic and therapeutic approaches, personalised medicine approaches, digital and other people-centred solutions for health care. In particular, patients are diagnosed early and accurately and receive effective, cost-efficient and affordable treatment, including patients with a rare disease, due to effective translation of research results into new diagnostic tools and therapies.
  • Premature mortality from non-communicable diseases is reduced by one third (by 2030), mental health and well-being is promoted, and the voluntary targets of the WHO Global Action Plan for the Prevention and Control of NCDs 2013-2020 are attained (by 2025), with an immediate impact on the related disease burden (DALYs)[5],[6], [7].
  • Health care systems benefit from strengthened research and innovation expertise, human capacities and know-how for combatting communicable and non-communicable diseases, including through international cooperation. In particular, they are better prepared to respond rapidly and effectively to health emergencies and are able to prevent and manage communicable diseases transmissions epidemics, including within healthcare settings.
  • Citizens benefit from reduced (cross-border) health threat of epidemics and AMR pathogens, in the EU and worldwide[8], [9].
  • Patients and citizens are knowledgeable of disease threats, involved and empowered to make and shape decisions for their health, and better adhere to knowledge-based disease management strategies and policies (especially for controlling outbreaks and emergencies).

The EU benefits from high visibility, leadership and standing in international fora on global health and global health security.

[1] Currently, around 50 million people in the EU are estimated to suffer from two or more chronic conditions, and most of these people are over 65. Every day, 22 500 people die in Europe from those diseases, counting of 87% of all deaths. They account for 550 000 premature deaths of people of working age with an estimated €115 billion economic loss per year (0.8% of GDP).

[2] AMR is estimated to be responsible for 25 000 deaths per year in the EU alone and 700 000 deaths per year globally. It has been estimated that AMR might cause more deaths than cancer by 2050.

[3] https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/12154-Europe-s-Beating-Cancer-Plan

[4] https://ec.europa.eu/health/funding/eu4health_en

[5] WHO Global Action Plan for the Prevention and Control of NCDs 2013-2020 (resolution WHA66.10), https://www.who.int/publications/i/item/9789241506236

[6] Including for instance the following voluntary targets (against the 2010 baseline): A 25% relative reduction in the overall mortality from cardiovascular diseases, cancer, diabetes, or chronic respiratory diseases; Halt the rise in diabetes and obesity; An 80% availability of the affordable basic technologies and essential medicines, including generics, required to treat major non-communicable diseases in both public and private facilities.

[7] Disability-adjusted life year (DALY) is a quantitative indicator of overall disease burden, expressed as the number of years lost due to ill-health, disability or early death.

[8] WHO global action plan on antimicrobial resistance, 2015

[9] EU One Health Action Plan against AMR, 2017

Eligibility & Conditions

General conditions

Applicants submitting a proposal under the blind evaluation pilot (see General Annex F) must not disclose their organisation names, acronyms, logos, nor names of personnel in Part B of their first stage application (see General Annex E).

General conditions

1. Admissibility conditions: described in Annex A and Annex E of the Horizon Europe Work Programme General Annexes.

Proposal page limits and layout: described in Part B of the Application Form available in the Submission System.

 

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.

 

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.

This topic is part of the blind evaluation pilot under which first stage proposals will be evaluated blindly.

Award criteria, scoring and thresholds are described in Annex D of the Work Programme General Annexes.

For the second stage, the thresholds for each criterion will be 4 (Excellence), 4 (Impact) and 3 (Implementation). The cumulative threshold will be 12.

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.

Eligible costs will take the form of a lump sum as defined in the Decision of 7 July 2021 authorising the use of lump sum contributions under the Horizon Europe Programme – the Framework Programme for Research and Innovation (2021-2027) – and in actions under the Research and Training Programme of the European Atomic Energy Community (2021-2025). [[This decision is available on the Funding and Tenders Portal, in the reference documents section for Horizon Europe, under ‘Simplified costs decisions’ or through this link: https://ec.europa.eu/info/funding-tenders/opportunities/docs/2021-2027/horizon/guidance/ls-decision_he_en.pdf]].

 

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.

Support & Resources

Online Manual is your guide on the procedures from proposal submission to managing your grant.

Horizon Europe Programme Guide contains 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.

National Contact Points (NCPs) – get guidance, practical information and assistance on participation in Horizon Europe. There are also NCPs in many non-EU and non-associated countries (‘third-countries’).

Enterprise Europe Network – contact your EEN national contact for advice to businesses with special focus on SMEs. The support includes guidance on the EU research funding.

IT Helpdesk – contact the Funding & Tenders Portal IT helpdesk for questions such as forgotten passwords, access rights and roles, technical aspects of submission of proposals, etc.

European IPR Helpdesk assists you on intellectual property issues.

CEN-CENELEC Research Helpdesk and  ETSI Research Helpdesk – the European Standards Organisations advise you how to tackle standardisation in your project proposal.

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.

Latest Updates

Last Changed: July 25, 2024

CALL UPDATE: FLASH EVALUATION RESULTS

EVALUATION results

Published: 07.12.2022

Deadline: 11.04.2024

Available budget: EUR 45,000,000

We recently informed the applicants about the evaluation results for their proposals.

The results of the evaluation for the topic HORIZON-HLTH-2024-DISEASE-03-08-two-stage are as follows:

Number of proposals submitted (including proposals transferred from or to other calls): 22

Number of inadmissible proposals: 0

Number of ineligible proposals: 0

Number of above-threshold proposals: 14

Total budget requested for above-threshold proposals: EUR 105,486,927.74

Number of proposals retained for funding: 7

Number of proposals in the reserve list: 2

Funding threshold[1]: 14.5

Ranking           

Number of proposals with scores lower or equal to 15 and higher or equal to 14: 7

Number of proposals with scores lower than 14 and higher or equal to 13: 5

Number of proposals with scores lower than 13 and higher or equal to 12: 2

Summary of observers’ report:

Two independent observers were asked to assist the European Health and Digital Executive Agency (HaDEA) in the evaluation of proposals submitted to 9 single and two-stage calls (covering 14 topics) with deadline on 11 April 2024, which were discussed during 2.5 weeks of consensus meetings. They followed the evaluation in order to assess and report on the implementation of the evaluation procedures, on the conduct and fairness of the evaluation process and on the application of the evaluation criteria. Based on the analysis conducted, the observers give independent advice for improvement of the evaluation process.

The evaluation process was fully transparent. The rules and guidelines to be followed were clearly communicated by documents provided to experts, by online and on-site briefings and by instructions given and, where necessary, repeated by the moderators. This ensured a fair and transparent procedure. The evaluation was conducted in an extremely fair and professional way, thanks to a thorough and meticulous preparation and to the helpful and competent HaDEA staff involved, including the quality checkers and the assistant team.

The lump sum method was used in this evaluation. Despite that the budget tables provided detailed information and that guidance was provided, many experts found it challenging assessing the proposed budgets.

The independent observers were impressed by the high quality of the evaluation, and made some further recommendations, for consideration in setting up the rules for the next framework programme. The most important advice is that a higher weight should be assigned to the Excellence criterion. It has at present a weight of 1/3 of the final score. This should be increased, as scientific excellence is the most important factor that determines the quality of a project. Such a change would be in line with international practices.

For questions, please contact the Research Enquiry Service.



[1] Proposals with the same score were ranked according to the priority order procedure set out in the call conditions (for HE, in the General Annexes to the Work Programme or specific arrangements in the specific call/topic conditions).


Last Changed: March 3, 2023

The Director-General responsible for the call HORIZON-HLTH-2024-DISEASE-03-two-stage, has decided to postpone the opening of this topic from 30 March 2023 to 26 April 2023.

Comparative effectiveness research for healthcare interventions in areas of high public health need | Grantalist