Clinical research by Comprehensive Cancer Infrastructures for the benefit of patients with common cancers

National and regional healthcare providers, healthcare payers, policymakers and authorities in European regions, EU Member States and Associated Countries have the evidence to engage in piloting, upscaling or implementing appropriate clinical research programmes for the diagnosis and treatment of patients afflicted by lung, bowel, breast or prostate cancer. Scope: Lung, bowel, breast and prostate cancer incidence, mortality and prevalence across EU Member States and Associated Countries are increasing while showing substantial variation, with Central and Eastern European communities, regions and countries particularly affected [4] . At the same time, the level of development of comprehensive cancer infrastructures continues to vary considerably across EU Member States and Associated Countries, contributing to inequalities, in particular in terms of clinical research capacity as well as quality of and access to innovative diagnostic and therapeutic interventions. Applicants should address all of the following: Comprehensive cancer infrastructures across the EU Member States and Associated Countries come together to conduct clinical research on lung, bowel, breast or prostate cancer focusing on at least one of the following areas: Innovative diagnostics; Radiotherapy, surgery, chemotherapy; Therapeutic cancer vaccines for the treatment of cancer patients with early-stage, advanced, metastatic or minimal residual disease (e.g. after debulking by surgery, chemotherapy, radiotherapy, or immunotherapy); Implementation of appropriate clinical practice guidelines for diagnosis and treatment in countries without or with limited Comprehensive Cancer Infrastructures; Comprehensive cancer infrastructures should extensively pilot and upscale innovative diagnostic or treatment programmes in at least four different EU Member States or Associated Countries. One of the four targeted EU Member States or Associated Countries should represent a country without or with a less developed comprehensive cancer infrastructure. To ensure that together they address - and whenever feasible - overcome challenges because of the national, regional, or local research and healthcare context (e.g. those faced by small(er) EU Member States, or due to a large rural population, or particular cancer burden, socio-economic or environmental situation, or limited clinical research capacity [5] ), when designing and conducting innovative clinical research programmes with added value for the timely diagnosis and treatment of patients with lung, bowel, breast or prostate cancer; Identify additional resources through the European Regional Development Fund (ERDF), the Technical Support Instrument [6] , the Resilience and Recovery Facility (RRF), philanthropy, the European Investment Bank Group (EIB [7] , EIF [8] ) or any other initiative; Innovative clinical research programmes should be defined together with patients and their caregivers/families using participative research models and adapted to the needs of the target population and the specificities of healthcare provision at local, regional, or national level, duly reflecting the (cultural) diversity and available resources across EU Member States and Associated Countries; Data should be disaggregated by sex, gender, age and other relevant variables, such as by measures of socio-economic status or ethnicity; All datasets produced should be described with metadata records in the EU dataset catalogue of the European Health Data Space, while all tools and models should take advantage of current European research infrastructures, should follow the principles of open science and made available through the future UNCAN.eu platform; Applicants should include an appropriate mix of stakeholders from various disciplines and sectors [9] and provide details of the clinical study(ies) in the dedicated annex using the template provided in the submission system. Successful proposals will be asked to join the 'Diagnosis and treatment” cluster [10] for the EU Cancer Mission and should include a budget for networking, attendance at meetings, and joint activities [11] . The Commission will facilitate coordination of these activities. The successful proposals are expected to build on relevant networks launched under the Europe’s Beating Cancer Plan that could facilitate cross-border clinical trials [12] , resources made available by relevant ESFRI Research Infrastructures [13] , and the Knowledge Centre on Cancer (KCC) to foster EU alignment and coordination [14] . [1] Any age group or cancer subtype [2] National or regional infrastructures that provide resources and services to support, improve and integrate cancer care, research, training of care professionals and education for cancer patients, survivors and their families/carers of any age group. Hence, comprehensive cancer infrastructures could consist of any combination, number or type of -public or private- cancer centre, hospital, university medical centre, research department or institute, company, public health facility, etc. [3] Innovators turn research results into new and better services and products, to remain competitive in a global marketplace and to improve the quality of life of Europe’s citizens. [4] Cancer inequalities registry: https://cancer-inequalities.jrc.ec.europa.eu/ [5] research laboratories, diagnostics and clinical trial infrastructures [6] Technical Support Instrument (TSI) , DG REFORM [7] Homepage | European Investment Bank [8] eif.org/index.htm [9] such as physicians, academia, patients and their caregivers, patient representatives, engineers, behavioural scientists, SMEs, business networks, insurance companies, charities and foundations, research organisations, civil society. [10] In order to address the objectives of the EU Cancer Mission, participants will collaborate in project clusters to leverage EU-funding, increase networking across sectors and disciplines, and establish a portfolio of EU Cancer Mission R&I and policy actions. [11] Examples of those activities are research or research capacity, organising joint workshops, establishing best practices, joint communication or citizen engagement activities with projects funded under other clusters and pillars of Horizon Europe, or other EU programmes, as appropriate. Proposals are not required to include details of these activities, as they will be defined during the grant agreement preparation and during the life of the project. [12] Such as the EU Network of comprehensive cancer centres EUNetCCC [13] Such as BBMRI, EATRIS, ELIXIR, ECRIN. [14] Hosted by the European Commission's Joint Research Centre (JRC). Especially through the ’European Guidelines and Quality Assurance Schemes for Breast, Colorectal and Cervical Cancer Screening and Diagnosis‘, and the ’European Cancer Information System (ECIS)’ and the ’European Cancer Inequalities Registry (ECIR), see https://knowledge4policy.ec.europa.eu/cancer_en.

Eligibility and submission conditions

"> General conditions 1. Admissibility conditions: Proposal page limit and layout 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 . 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. 5a. Evaluation and award: Award criteria, scoring and thresholds described in Annex D of the Work Programme General Annexes. 5b. Evaluation and award: Submission and evaluation processes The thresholds for each criterion will be 4 (Excellence), 4 (Impact) and 4 (Implementation). The cumulative threshold is 12. described in Annex F of the Work Programme General Annexes and the Online Manual . 5c. Evaluation and award: 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 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 ]]. The granting authority may, up to 4 years after the end of the action, object to a transfer of ownership or to the exclusive licensing of results, as set out in the specific provision of Annex 5. described in Annex G of the Work Programme General Annexes. Specific conditions described in the specific topic of the Work Programme Application and evaluation forms and model grant agreement (MGA): Application form templates Please use the application form that you will find in the Submission System. You can find examples of standard application forms in the Reference Documents page . Evaluation form templates — will be used with the necessary adaptations Standard evaluation form (HE RIA, IA) Guidance HE Programme Guide   Model Grant Agreements (MGA) Lump Sum MGA   Call-specific instructions   Detailed budget table (HE LS)   Information on clinical studies (HE)   Guidance: "Lump sums - what do I need to know?" Additional documents: HE Main Work Programme 2026-2027 – 1. General Introduction HE Main Work Programme 2026-2027 – 12. Missions HE Main Work Programme 2026-2027 – 15. General Annexes HE Framework Programme and Rules for Participation Regulation 2021/695 HE Specific Programme Decision 2021/764 EU Financial Regulation 2024/2509 Decision authorising the use of lump sum contributions under the Horizon Europe Programme 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

Hivatkozott dokumentumok

Annex A Horizon Europe Programme Guide Online Manual [This [decision Standard evaluation form (HE RIA, IA) Lump Sum MGA Detailed budget table (HE LS) Information on clinical studies (HE) Guidance: "Lump sums - what do I need to know?" HE Main Work Programme 2026-2027 – 1. General Introduction HE Main Work Programme 2026-2027 – 12. Missions Rules for Legal Entity Validation, LEAR Appointment and Financial Capacity Assessment EU Grants AGA — Annotated Model Grant Agreement Funding & Tenders Portal Terms and Conditions