💰 Funding Details

HORIZON-MISS-2025-02-CANCER-03

"Innovative surgery as the cornerstone of affordable multi-modal therapeutic interventions benefitting cancer patients with locally advanced or metastatic disease"

Key Facts

* Programme / Mission: Horizon Europe – Mission on Cancer

* Type of Action: HORIZON-RIA (Research & Innovation Action)

* Call Identifier: HORIZON-MISS-2025-02-CANCER-03

* Opening Date: 06 May 2025

* Deadline (single stage): 16 September 2025, 17:00 (Brussels time)

* Max. EU Contribution per project: up to €31 million (100 % of eligible direct costs + 25 % indirect)

Strategic Purpose

This call aims to validate innovative, surgery-centred, multi-modal interventions for patients with *locally advanced or metastatic solid tumours* who are too often excluded from clinical studies. Proposals must generate robust evidence on:

1. Clinical benefit – overall survival, patient-reported outcomes & quality of life.

2. Affordability – cost-effectiveness analyses tailored to diverse healthcare settings in your country.

3. Scalability & equity – adaptation to local resources, sex/gender, age, socio-economic & ethnic variables.

Mandatory Technical Elements

* Investigator-initiated clinical trials (academic sponsor) validating *surgery-centred* combinations (e.g. minimally-invasive robotic surgery + intra-operative radiotherapy).

* Translational research strictly limited to activities that support trial conduct & analyses.

* SSH integration – social innovation, participatory research with patients/caregivers.

* Open Science & FAIR data – metadata in the EU dataset catalogue of the European Health Data Space and tools/models uploaded to the future UNCAN.eu platform.

* Networking budget – participation in the Cancer Mission “Diagnosis & Treatment” cluster events.

Eligible Participants

Consortia must include a minimum of three independent legal entities from three different your country (Member States or Associated Countries). A competitive proposal normally involves:

* University hospitals / comprehensive cancer centres (trial sponsor & PI).

* SMEs & med-tech companies (device/robotics/AI).

* Patient organisations & caregivers.

* Health economics & SSH experts.

* Regional / national health authorities & payers.

Budget Structure (indicative)

* 55-65 % – Clinical trial implementation (sites, monitoring, IMP/device supply).

* 10-15 % – Data management, biostatistics, FAIR compliance.

* 8-12 % – Health-economic & equity analyses.

* 5-8 % – Patient engagement & SSH activities.

* 3-5 % – Mission cluster networking & communication.

Expected Impact

* Tangible clinical evidence enabling equitable uptake of affordable, cutting-edge surgical solutions across your country.

* New market opportunities for European SMEs in surgical robotics, imaging and intra-operative devices.

* Contribution to Mission objective “Optimise diagnosis & treatment” and European Beating Cancer Plan.

📊 Evaluation Criteria

Expert Evaluation Criteria Explained

1. Excellence (Score 0-5, Threshold 4)

* Clarity & Relevance: Does the surgical intervention address a clearly defined clinical gap in metastatic/locally advanced cancer?

* Novelty: Level of innovation in combining surgery with other modalities or devices.

* Soundness of Methodology: Robust trial design, patient stratification, statistical power, translational sub-studies.

* Interdisciplinarity & SSH Integration: Genuine integration of social sciences, economics, engineering & patient expertise.

2. Impact (Score 0-5, Threshold 4)

* Advancement towards Mission Objectives: Contribution to equitable, affordable treatment and 3 million lives by 2030 target.

* Credibility of Pathway to Market & Healthcare Uptake: Implementation plan, payer engagement, regulatory roadmap.

* Measures to Maximise Impact: Open Science, IP management, stakeholder communication, clustering with other Mission projects.

* Scale & Significance of Expected Benefits: Survival gain, QoL, cost-effectiveness across diverse your country health systems.

3. Quality & Efficiency of Implementation (Score 0-5, Threshold 4)

* Work Plan & Resources: Coherent work packages, realistic timeline, adequate budget split.

* Consortium Competence: Complementarity, leadership experience in multi-national trials, GCP compliance.

* Risk Management: Mitigation strategies for recruitment delays, MDR certification, data privacy.

* Governance: Clear decision-making, patient involvement structures, DSMB, ethics management.

Cumulative Threshold: 12/15 (each criterion ≥4). Proposals below any threshold are rejected.

📝 Application Strategy

Strategic Application Guide

1. Build a Mission-Ready Consortium

1. Map leading surgeons & oncology trialists with a track record in investigator-initiated studies.

2. Engage *at least* 2-3 SMEs providing innovative surgical tools; negotiate in-kind device provision to reduce costs.

3. Formalise patient & caregiver boards early; co-design endpoints and consent materials.

4. Add health-economics teams and SSH researchers to address affordability, equity and social innovation.

5. Secure letters of support from your country ministries/health authorities for future implementation.

2. Craft a Compelling Scientific Narrative

* Unmet Need: Quantify survival gaps for metastatic patients excluded from trials.

* Intervention Rationale: Provide pre-clinical or phase I/II data supporting the surgery-centred combination.

* Trial Design: Adaptive, multi-centre, randomised (where ethical) with co-primary endpoints: OS & QoL.

* Stratification: Sex, age, socio-economic & ethnic factors; incorporate PRO tools validated in local languages.

3. Demonstrate Impact & Uptake

* Build a cost-effectiveness model comparing current standard-of-care vs new intervention across high-, middle- and low-resource hospitals in your country.

* Produce an implementation toolkit (training videos, reimbursement dossiers) for rapid adoption.

* Outline alignment with KCC guidelines and how data will feed ECIS & ECIR registries.

4. Excellence in Open Science

* Develop a data management plan (DMP) with machine-readable metadata, GDPR compliance & linkage to UNCAN.eu APIs.

* Release AI models (e.g. intra-operative imaging algorithms) under permissive licenses (Apache 2.0).

5. Flawless Implementation

* Provide risk matrices for patient recruitment, device supply chains, regulatory approvals (MDR, CTR).

* Integrate independent Data Safety Monitoring Board and GCP-compliant monitoring strategy.

6. Budget Optimisation

* Use *unit-cost per patient* methodology; justify high-cost devices with reuse potential across sites.

* Allocate ≥5 % to dissemination, exploitation & citizen engagement.

💡 Success Factors

Strong Surgical Trial Leadership

A coordinating investigator with a proven **EORTC/CTO trial portfolio** reassures evaluators of GCP compliance and recruitment capacity.

Integrated Health-Economic & Equity WP

Embedding cost-effectiveness, budget-impact and **equity stratifiers** (sex, socio-economic, ethnicity) demonstrates real-world applicability.

Patient-Defined Endpoints

Using participatory workshops to derive **co-primary PRO/QoL measures** ensures SSH integration and boosts Impact scores.

FAIR-by-Design Data Architecture

Early engagement with EOSC/UNCAN.eu architects and use of **common data models (OMOP, DICOMweb)** streamlines open science obligations.

Regulatory & MDR Readiness

Including clinical evaluation reports and notified-body timelines for any class IIb/III devices de-risks implementation.

Mission Cluster Synergies

Planning joint workshops with projects on AI imaging or genomics within the Diagnosis & Treatment cluster magnifies EU added value.

❌ Common Mistakes to Avoid

Device-led (non-surgical) focus

Some consortia centre the proposal on a novel device **without** demonstrating that surgery remains the cornerstone of the intervention, leading to misalignment with the topic scope.

Over-ambitious multi-tumour basket

Including too many tumour entities inflates sample size, complicates regulatory approvals and dilutes statistical power; evaluators flag this as *methodologically weak*.

Neglecting Cost-Effectiveness Analyses

Affordability is an explicit requirement; proposals lacking a **formal health-economic WP** or payer engagement score low on *Impact*.

Tokenistic Patient Involvement

Listing a patient group as partner but **failing to co-create endpoints, consent forms or dissemination activities** is penalised under *Excellence* and *Implementation*.

Insufficient Open Science Compliance

Forgetting metadata entry in the EU dataset catalogue or not planning to release code/models openly triggers negative remarks on *Impact*.

Ignoring Mission Cluster Budget

Missing or under-budgeting travel & networking costs for the Cancer Mission cluster meetings shows poor awareness of call obligations.

Innovative surgery as the cornerstone of affordable multi-modal therapeutic interventions benefitting cancer patients with locally advanced or metastatic disease

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