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Comparative effectiveness research for healthcare interventions in areas of high public health need
Horizon Europe - Cluster 1 - Destination 3: Tackling diseases and reducing disease burden
Estimated EU contribution per project
between € 6,000,000.00 and € 7,000,000.00
Link to the call
Link to the submission
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”.
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.
Expected effects and impacts
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 principles.
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.
- 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 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.
Regions / countries for funding
Moldova (Moldova), Albania (Shqipëria), Armenia (Հայաստան), Bosnia and Herzegovina (Bosna i Hercegovina / Босна и Херцеговина), Faeroes (Føroyar / Færøerne), Georgia (საქართველო), Island (Ísland), Israel (ישראל / إِسْرَائِيل), Kosovo (Kosova/Kosovë / Косово), Montenegro (Црна Гора), Morocco (المغرب), North Macedonia (Северна Македонија), Norway (Norge), Serbia (Srbija/Сpбија), Tunisia (تونس /Tūnis), Türkiye, Ukraine (Україна), United Kingdom
EU Body, Education and training institution, International organization, Natural Person, Non-Profit Organisation (NPO) / Non-Governmental Organisation (NGO), Other, Private institution, incl. private company (private for profit), Public Body (national, regional and local; incl. EGTCs), Research Institution incl. University, Small and medium-sized enterprise (SME)
To be eligible for funding, applicants must be established in one of the following countries:
- the Member States of the European Union, including their outermost regions
- the Overseas Countries and Territories (OCTs) linked to the Member States
- third countries associated to Horizon Europe - see list of particpating countries
Applications may be submitted by one or more legal entities, which may be established in a Member State, Associated Country or, in exceptional cases and if provided for in the specific call conditions, in another third country.
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.
Any legal entity, regardless of its place of establishment, including legal entities from non-associated third countries or international organisations (including international European research organisations) is eligible to participate (whether it is eligible for funding or not), provided that the conditions laid down in the Horizon Europe Regulation have been met, along with any other conditions laid down in the specific call topic.
A ‘legal entity’ means any natural or legal person created and recognised as such under national law, EU law or international law, which has legal personality and which may, acting in its own name, exercise rights and be subject to obligations, or an entity without legal personality.
- Affiliated entities — Affiliated entities (i.e. entities with a legal or capital link to a beneficiary which participate in the action with similar rights and obligations to the beneficiaries, but which do not sign the grant agreement and therefore do not become beneficiaries themselves) are allowed, if they are eligible for participation and funding.
- Associated partners — Associated partners (i.e. entities which participate in the action without signing the grant agreement, and without the right to charge costs or claim contributions) are allowed, subject to any conditions regarding associated partners set out in the specific call conditions.
- Entities without legal personality — Entities which do not have legal personality under their national law may exceptionally participate, provided that their representatives have the capacity to undertake legal obligations on their behalf, and offer guarantees to protect the EU’s financial interests equivalent to those offered by legal persons.
- EU bodies — Legal entities created under EU law including decentralised agencies may be part of the consortium, unless provided for otherwise in their basic act.
- Joint Research Centre (‘JRC’)— Where provided for in the specific call conditions, applicants may include in their proposals the possible contribution of the JRC but the JRC will not participate in the preparation and submission of the proposal. Applicants will indicate the contribution that the JRC could bring to the project based on the scope of the topic text. After the evaluation process, the JRC and the consortium selected for funding may come to an agreement on the specific terms of the participation of the JRC. If an agreement is found, the JRC may accede to the grant agreement as beneficiary requesting zero funding or participate as an associated partner, and would accede to the consortium as a member.
- Associations and interest groupings — Entities composed of members (e.g. European research infrastructure consortia (ERICs)) may participate as ‘sole beneficiaries’ or ‘beneficiaries without legal personality’. However, if the action is in practice implemented by the individual members, those members should also participate (either as beneficiaries or as affiliated entities, otherwise their costs will NOT be eligible.
Relevance for EU Macro-Region
EUSAIR - EU Strategy for the Adriatic and Ionian Region, EUSALP - EU Strategy for the Alpine Space, EUSBSR - EU Strategy for the Baltic Sea Region, EUSDR - EU Strategy for the Danube Region
UN Sustainable Development Goals (UN-SDGs)
All proposals must be submitted electronically via the Funders & Tenders Portal electronic submission system (accessible via the topic page in the Search Funding & Tenders section). Paper submissions are NOT possible.
Proposals must be complete and contain all parts and mandatory annexes and supporting documents, e.g. plan for the exploitation and dissemination of the results including communication activities, etc.
The application form will have two parts:
- Part A (to be filled in directly online) contains administrative information about the applicant organisations (future coordinator and beneficiaries and affiliated entities), the summarised budget for the proposal and call-specific questions;
- Part B (to be downloaded from the Portal submission system, completed and then assembled and re-uploaded as a PDF in the system) contains the technical description of the project.
Annexes and supporting documents will be directly available in the submission system and must be uploaded as PDF files (or other formats allowed by the system).
This call follows a two-stage approach.
This topic is part of the blind evaluation pilot under which first stage proposals will be evaluated blindly. Applicants submitting a proposal under the blind evaluation pilot must not disclose their organisation names, acronyms, logos nor names of personnel in Part B of their first-stage application.
The limit for a first-stage application is 10 pages. The limit for a full application (Part B) is 50 pages.
The award criteria are described in General Annex D. The following exceptions apply:
For the second stage, the thresholds for each criterion will be 4 (Excellence), 4 (Impact) and 3 (Implementation). The cumulative threshold will be 12.
Eligible costs will take the form of a lump sum.