Evaluation Criteria and How to Maximise Your Score

Horizon Europe RIA proposals are assessed on Excellence, Impact, Implementation (0–5 points each). For this topic, minimum 4/5 per criterion and a cumulative ≥ 12/15 are required.

1. Excellence (Weight 1, Threshold 4)

* Clarity & pertinence of objectives – Align explicitly with the Mission’s outcome targets (safe, effective, less toxic, accessible treatments).

* Soundness of concept & methodology – Provide rationale for target selection, pre-clinical data, adaptive trial designs, biostatistics.

* Interdisciplinarity & innovation – Highlight novel therapeutic modality, AI-enabled diagnostics, SSH integration.

* Sex/gender, diversity & ethics – Present stratified analyses and tailored QoL tools.

💡 Tip: Use a table cross-linking each objective to specific WPs, endpoints and Mission KPIs.

2. Impact (Weight 1, Threshold 4)

* Credibility of pathways to outcomes/impacts – Include logic model showing short-, medium- and long-term effects (clinical practice, policy, survivorship).

* Measures to maximise impact – Concrete exploitation plan (MAA route, Paediatric Use Marketing Authorisation, HTA dossiers), data sharing, open science, standards adoption.

* Barriers & mitigation – Recruitment, regulatory, manufacturing, reimbursement; provide robust risk matrix.

* Contribution to EU policies & missions – Reference Europe’s Beating Cancer Plan, Rare Disease Strategy, European Health Data Space.

💡 Tip: Quantify impact (e.g., projected survival gain, cost-utility ratios, number of patients reachable in 5 years after project end).

3. Quality & Efficiency of Implementation (Weight 1, Threshold 4)

* Work plan, milestones, resources – Logical, time-bound, matched to lump-sum payment schedule.

* Consortium quality – Complementary expertise, clear roles, partner experience in early-phase paediatric trials.

* Governance & decision-making – Steering committee, DSMB, patient advisory board, regulatory advisory group.

* Allocation of budget & risk management – Transparent WP-level lump sums, contingency, subcontracting strategy.

* Clustering & coordination – Budget line and plan for Mission Cancer cluster activities.

💡 Tip: Provide a one-page responsibility matrix (RACI) and a graphical timeline showing critical path to FPI and database lock.

Additional Portfolio Considerations

* After scoring, the Commission may adjust to ensure at least one high-ranked project for 0-14 y and 15-19 y cohorts. High scores alone are not enough—state clearly which age group(s) you address.

Scoring Scale Recap

0 = Fails / not addressed • 1 = Poor • 2 = Fair • 3 = Good • 4 = Very Good • 5 = Excellent (no shortcomings)

Deliver ≥ 4.5 on each criterion to remain competitive in a likely high-quality field.

Application Strategy

1. Shape a Compelling Clinical Question

* Start with an unmet paediatric/adolescent oncological need with < 50 % 5-year OS.

* Demonstrate strong pre-clinical/early-clinical evidence for your therapeutic asset or combination.

* Map to Mission Cancer objectives: better, safer, more accessible treatments.

2. Assemble a High-Impact Consortium

* Core clinical network: ≥ 5-8 high-volume paediatric oncology sites in ≥ 3 MS/AC, capable of early-phase trials.

* Technology partners: SMEs/pharma for IMP supply; diagnostics company/academic lab for companion Dx; AI/data specialists.

* Support actors: Patient & survivor organisations (co-design, outreach), SSH teams (ethics, acceptability, health economics), regulators (as advisory board), ECRIN/PedCRIN (trial management).

* Balanced gender & geographical representation; include Widening countries if possible.

3. Design a Robust Clinical-Scientific Work Plan

1. WP1 – Trial Preparation & Regulatory Alignment

* Scientific advice meetings (EMA, national), paediatric-investigation-plan updates, IMPD, CTA submissions.

2. WP2 – Phase I Dose-Escalation

* Bayesian/continual reassessment design, safety endpoints, PK/PD.

3. WP3 – Phase I/II Expansion Cohorts

* Efficacy signals (ORR, MRD, surrogate biomarkers), adaptive stopping rules.

4. WP4 – Companion Diagnostic Development (e.g., liquid biopsy, radiomics).

5. WP5 – Long-term Follow-up & Late-Effect Monitoring

* QoL tools, cardiac MRI, fertility assessments, digital health apps.

6. WP6 – Data Management & FAIR Sharing

* Metadata to EUHD catalogue, pipelines for UNCAN.eu, GDPR compliance.

7. WP7 – SSH, Ethics & Patient Engagement

8. WP8 – Exploitation, Sustainability & Policy Uptake

9. WP9 – Coordination & Cluster Activities

4. Build a Lump-Sum-Ready Budget

* Allocate costs per WP, include buffer for IMP manufacturing and regulatory fees.

* Validate with F&T portal lump-sum calculator; ensure risk/contingency strategy.

* Align milestone payments with critical trial gates (first-patient-in, dose-escalation complete, database lock, etc.).

5. De-Risk the Submission

* Clinical Annex: Complete tables on design, endpoints, recruitment numbers, safety monitoring, DSMB.

* Ethics Self-Assessment: Consent/assent templates, biobanking, data transfer agreements.

* Gender, inclusiveness & diversity plan: Recruitment targets by sex, age, socio-economic status.

* Regulatory & HTA Roadmap: Show early parallel consultation, plan for Orphan or PRIME designations.

6. Excellence in Proposal Writing

* Address each evaluation sub-criterion explicitly; use evidence boxes, patient quotes, Gantt diagrams.

* Keep Part B within 45-page limit; move tables/figures to annex where allowed.

* Include letters of commitment from key partners & patient groups.

* Run a mock evaluation with external reviewers ≥ 4 weeks before deadline.