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Grant Details

Grant Analysis

Purpose & Target

- - Core Objective: To accelerate the development of innovative, effective, and less toxic treatments for paediatric and adolescent cancer by funding investigator-initiated multinational early-stage clinical trials. - Target Recipient Type and Size: Open to a diverse range of organizations, including academia, paediatric oncology centers, hospitals, healthcare practitioners, patient and survivor organizations, data scientists, regulators, and industry. No specific size restrictions are indicated. - MUST state if grant is 'SECTOR-SPECIFIC' or 'SECTOR-AGNOSTIC': SECTOR-SPECIFIC - Geographic Scope: Organizations from EU Member States and Associated Countries are eligible. Non-EU/non-Associated Countries may also be eligible if specific funding provisions are made. - Key Filtering Criteria for Initial Grant Screening: - Focus on paediatric (0-14 years) and/or adolescent (15-19 years) cancer patients. - Projects must involve early-stage (phase 1 and 1/2) investigator-initiated multinational clinical trials. - Emphasis on cancers with poor prognosis (5-year overall survival less than 50%). - Projects should aim to deliver affordable and accessible treatment solutions. - Grant Frequency and Program Context: This is a call within the 2025 Work Programme for the Horizon Europe 'Mission on Cancer', which aims to improve the lives of over 3 million people by 2030. Calls under this mission are recurring within the Horizon Europe framework (2021-2027).

Financial Structure

  • Funding Type: The grant takes the form of a 'lump sum contribution' (HORIZON Lump Sum Grant).
  • Total Budget for this Call: The total budget allocated for 'HORIZON-MISS-2025-02-CANCER-04' is 25,000,000.0 EUR.
  • Individual Grant Range: This topic expects to award 4 grants. The 'minimum contribution' per grant is 6,000,000.0 EUR, and the 'maximum contribution' per grant is 8,000,000.0 EUR.
  • Eligible Costs: The lump sum is determined based on applicants' estimated direct and indirect project costs. Eligible cost categories include:
  • Personnel costs (employees, natural persons under direct contract, seconded persons, SME owners, natural person beneficiaries).
  • Subcontracting costs.
  • Purchase costs (travel, subsistence, equipment, other goods, works, and services).
  • Other cost categories (financial support to third parties, internally invoiced goods/services, transnational/virtual access to research infrastructure, PCP/PPI procurement, Euratom Cofund staff mobility, ERC additional funding).
  • Ineligible Costs: Must exclude any costs that are ineligible under Horizon Europe rules (specific list not provided).
  • Indirect Costs: A flat rate of 25% is applied to eligible direct costs when calculating the estimated lump sum proposal budget.
  • Payment Schedule: Payments do not depend on actual costs incurred. Lump sum contributions are paid per 'work package' once the conditions for that work package have been properly implemented and all other grant agreement obligations are met.
  • Pre-financing: Follows standard Horizon Europe rules, with the amount fixed in the grant agreement.
  • Mutual Insurance Mechanism: Between 5% and 8% of the total lump sum is retained as a contribution to this mechanism.
  • Financial Reporting and Audits: Beneficiaries have no obligation to report actual costs incurred for the action. Normally, there are no financial checks, reviews, or ex-post audits focused on costs. Controls will primarily focus on the technical implementation of the action and the fulfilment of work package conditions. If conditions are not met, the grant may be reduced or recovered.

Eligibility Requirements

Organization Types
  • Open to a diverse range of entities, including:
  • Academia
  • Data scientists
  • Paediatric oncology centers
  • Hospitals
  • Healthcare practitioners
  • Liquid biopsy companion diagnostics experts
  • Cancer patients and survivors (organizations representing them)
  • Caregivers (organizations representing them)
  • Regulators
  • Industry (including SMEs and larger enterprises)
Consortium Requirements
  • Required: Projects must be undertaken by a consortium that brings together a diverse range of stakeholders and organizations from across Europe and beyond.
Geographic Location
  • Organizations located in EU Member States are eligible.
  • Organizations located in countries 'associated' with Horizon Europe are eligible.
  • Organizations from non-EU/non-Associated Countries may be eligible if specific funding provisions are made as detailed in the Horizon Europe Programme Guide (not provided in this document).
Project Focus
  • Must specifically focus on Investigator-initiated multinational early-stage innovative clinical trials for paediatric cancer.
  • Target age groups for trials: children (0-14 years) and/or adolescents (15-19 years) at first cancer diagnosis.
  • Trials should prioritize cancers with poor prognosis (defined as a 5-year overall survival rate of less than 50% from time of diagnosis).
Legal and Financial Capacity
  • Applicants must demonstrate sufficient financial and operational capacity.
  • Eligible costs will take the form of a 'lump sum contribution'.
Exclusion Criteria
  • Projects not focusing on early-stage clinical trials for paediatric/adolescent cancer are not eligible.
  • Organizations not meeting the financial and operational capacity requirements may be excluded.
  • Projects with scopes that fall outside the defined objectives of improving access to innovative, effective, and less toxic treatments for paediatric cancer patients are not eligible.

Application Process

Application Deadlines and Submission
  • Application Deadline: 2025-09-16T00:00:00+0000.
  • Submission System: Proposals must be submitted via the Electronic Submission Service on the Funding & Tenders Portal.
  • Submission Model: Single-stage submission procedure.
Required Documentation and Materials
  • Application Form: Use the standard application form (HE RIA, IA) specific to this call, available in the Submission System.
  • Proposal Content: Adhere to specified page limits and layout as described in Part B of the Application Form.
  • Budget Details: Provide a detailed budget table (HE LS) as part of the proposal.
  • Clinical Studies Information: Include details of clinical studies using the dedicated template provided in the submission system.
  • Accounting Practices Declaration: Beneficiaries must declare that they have followed their own accounting practices for preparing the estimated budget.
Evaluation Process
  • Review Process: Proposals are evaluated by external independent experts following standard Horizon Europe procedures.
  • Budget Assessment: Experts with financial know-how will check budget estimates against relevant benchmarks (e.g., market prices, statistical data, historical data) to ensure proposed resources align with activities and expected outputs.
Grant Agreement and Collaboration
  • Grant Agreement Type: The grant agreement will be a 'Lump Sum Model Grant Agreement' (HORIZON-AG-LS).
  • Project Coordination: The European Commission will facilitate coordination among successful projects.
  • Networking Budget: Proposals should include a budget allocation for networking, attendance at meetings, and potential joint activities with other projects.
  • Cluster Participation: Awarded projects will be asked to join the 'Diagnosis and Treatment' cluster for the Cancer Mission.
Application Assistance and Support
  • Comprehensive Guidance: Applicants can access support through the Online Manual, Horizon Europe Programme Guide, and Funding & Tenders Portal FAQ.
  • Enquiry Services: Research Enquiry Service for general questions about European research, and IT Helpdesk for technical submission issues.
  • National Contact Points (NCPs): Provide guidance and assistance on participation in Horizon Europe, including in non-EU/non-associated countries.
  • Enterprise Europe Network: Offers advice to businesses, especially SMEs, on EU research funding.
  • European IPR Helpdesk: Assists with intellectual property issues.
  • Standardisation Advice: CEN-CENELEC Research Helpdesk and ETSI Research Helpdesk offer guidance on standardisation in project proposals.
  • Partner Search: A service is available to help find partner organizations for proposals.

Evaluation Criteria

General Award Criteria
  • Proposals will be evaluated based on three main criteria:
  • Excellence
  • Impact
  • Quality and Efficiency of the Implementation
  • Thresholds for each criterion:
  • Excellence: 4
  • Impact: 4
  • Implementation: 4
  • Cumulative threshold across all criteria: 12
  • Detailed scoring factors for 'Excellence', 'Impact', and 'Quality and Efficiency of the Implementation' are not provided in the supplied grant documents but are referenced to Annex D and F of the Horizon Europe Work Programme General Annexes.
Specific Scoring Factors (derived from scope and expected outcomes)
  • Expected to deliver innovative, more effective, less toxic treatments and care solutions for children and adolescents with cancer.
  • Contribution to providing scientific evidence for affordable and accessible treatment solutions that can be implemented by healthcare systems in European regions, Member States, and Associated Countries.
  • Plans for ensuring accessibility and re-usability of relevant trial data, supporting the future UNCAN.eu research data platform.
  • Ability to design and conduct innovative investigator-initiated multinational early-stage clinical trials focusing on poor prognosis cancers.
  • Development of innovative clinical tools (e.g., companion diagnostics) tailored to childhood and adolescent cancers for accurate evaluation of treatment outcomes.
  • Demonstrated effective contribution of Social Science and Humanities (SSH) disciplines and expertise to enhance societal impact.
  • Encouragement for the use of artificial intelligence, machine learning, and deep learning tools where relevant.
  • Consideration of existing resources like paediatric cancer registries and alignment with established EU-funded initiatives (e.g., PedCRIN/ECRIN, ITCC4, c4c, EU PEARL, ERN PaedCan).
Award Balancing Condition
  • To ensure a balanced portfolio covering both children and adolescents, grants will be awarded not only by ranking but also to at least:
  • One highest-ranked application targeting the 0-14 age group (children).
  • One highest-ranked application targeting the 15-19 age group (adolescents).
  • This condition applies provided these applications attain all specified thresholds. Applications targeting both age groups will be considered for both categories.

Compliance & Special Requirements

Regulatory Compliance
  • Timely engagement with regulatory authorities is crucial to inform clinical trial design and ensure feasibility, reflecting the nature of the project (clinical trials).
Data Protection and Privacy
  • All generated datasets must be described with metadata records and registered in the EU dataset catalogue of the European Health Data Space.
  • All tools and models developed should adhere to 'open science principles' and be made accessible through the future UNCAN.eu platform.
  • Data should be disaggregated by sex, gender, age, and other relevant variables to ensure comprehensive analysis and address equity.
Ethical Standards
  • Projects must adhere to ethical standards and research integrity principles applicable under Horizon Europe.
Intellectual Property
  • The management of intellectual property will be governed by the provisions of the grant agreement.
Risk Management and Financial Oversight
  • For lump sum grants, financial controls (checks, reviews, audits) will shift focus from incurred costs to the technical implementation of the action and the fulfilment of 'work package' conditions. Non-compliance with these conditions may lead to grant reduction or recovery.
Cross-cutting Themes and Strategic Alignment
  • 'Social Science and Humanities (SSH)' disciplines and expertise must be effectively contributed and involved in proposals to enhance the societal impact of research activities.
  • Projects are expected to build on the support of the 'Knowledge Centre on Cancer (KCC)'.
  • Due consideration should be given to existing EU-funded initiatives in paediatric oncology (e.g., PedCRIN/ECRIN, ITCC4, c4c, EU PEARL, ERN PaedCan) to ensure synergy and avoid duplication.
  • The mission aligns with broader EU strategies, including the 'European Green Deal' (Zero Pollution Action Plan, Farm to Fork strategy) and industrial/digitalisation strategies (upscaling and digitalisation of services, innovation in diagnostics).
  • AI, machine learning, and deep learning approaches are encouraged for better understanding of cancer, improving prevention, screening, early detection, diagnosis, treatment, and patient management.
  • Projects should contribute to 'equitable access' in all areas of cancer control.
Project Implementation and Knowledge Sharing
  • Projects should address gaps in knowledge, expertise, tools, data, and resources in paediatric oncology.
  • Cooperation within projects must be multinational, cross-sectoral, and multidisciplinary.
  • Exploitation of existing resources, such as paediatric cancer registries, is encouraged.

Grant Details

paediatric cancer childhood cancer adolescent cancer clinical trials oncology cancer research healthcare medical research lump sum funding horizon europe eu funding innovation treatment development rare diseases digital health artificial intelligence machine learning data science multinational collaboration research and innovation action public health sdg3
Investigator-initiated multinational early-stage innovative clinical trials for paediatric cancer
48335306TOPICSen
Horizon Europe
UNIVERSITY NGO ENTERPRISE SME OTHER
AT BE BG HR CY CZ DK EE FI FR DE GR HU IE IT LV LT LU MT NL PL PT RO SK SI ES SE AL BA GE IS IL MD ME MK NO RS CH TR UA UK
HEALTHCARE TECHNOLOGY
DEVELOPMENT
OTHER
SDG3 SDG9 SDG17
FUNDING RESEARCH_DEVELOPMENT CAPACITY_BUILDING NETWORKING
25000000.00
6000000.00
8000000.00
EUR
100.00
Sept. 16, 2025, midnight
None