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Pragmatic clinical trials to optimise immunotherapeutic interventions for patients with refractory cancers

European Commission

Expected Outcome:

Proposals under this topic should aim to deliver results that are directed and tailored towards and contribute to all of the following expected outcomes:

Patients with refractory cancers and their caregivers/families will have access to optimised, tailored and affordable immunotherapeutic interventions that increase their quality of life, across European regions, EU Member States and Associated Countries;
Healthcare professionals and academia will have access to clinical evidence, on effectiveness of immunotherapeutic interventions, to deploy evidence-based treatment interventions with improved patient selection that improve outcomes in real life, i.e. in routine healthcare, for patients with refractory cancers who often present with co-morbidities;
National healthcare providers, policymakers and authorities in European regions, EU Member States and Associated Countries will have the evidence to implement and reimburse optimised and affordable immunotherapeutic interventions in their healthcare systems, including in everyday medical practice.

Scope:

While cancer research and innovation have generated novel treatment options, patients with refractory cancers across Europe need access to more effective, affordable and tailored cancer immunotherapeutic interventions which keep up with increasing demands in a complex and fragmented oncology healthcare landscape with spiralling healthcare costs.

Pragmatic clinical trials focus on choosing between care options. Pragmatic trials evaluate effectiveness of interventions in settings that more closely resemble routine, real-world settings, aiming to produce evidence directly applicable to clinical practice[1].

Proposals should address all the following:

Conduct randomised or cluster-randomised academic investigator-initiated[2] pragmatic clinical trials that benefit patients with refractory cancers - at any stage of the disease, for any cancer subtype, in any age group or part of society - to deliver effective, affordable and tailored immunotherapeutic interventions for implementation by healthcare systems at the level of local communities, European regions, EU Member States and Associated Countries.
All data should be disaggregated by sex, gender, age and other relevant variables, such as by measures of socio-economic status or ethnicity. Translational research is limited to supporting biomarker-informed patient stratification and the conduct and analyses of the proposed clinical trial(s).
The primary and secondary endpoints of the pragmatic clinical trials should target overall survival, patient-reported outcomes and quality of life issues considered important by and for cancer patients and their caregivers/families. Such endpoints should be defined together with patients and their caregivers/families through research that stimulates social innovation and supports end-user engagement using participative research models.
The chosen treatment intervention(s) should be adapted to the particular needs of the target population and to the specificities of the provision of care at local, regional, or national level, duly reflecting the diversity across EU Member States and Associated Countries. Furthermore, affordability and accessibility should be taken into account.
Applicants should include an appropriate mix of stakeholders from various disciplines, sectors[3] and regional as well as national health authorities, and provide details of the clinical study(ies) in the dedicated annex using the template provided in the submission system.

The successful proposals are expected to build on resources made available by the Knowledge Centre on Cancer (KCC)[4] to foster EU alignment and coordination.

Successful proposals will be asked to join the 'Diagnosis and Treatment' cluster for the EU Cancer Mission[5] and should include a budget for networking, attendance at meetings, and joint activities[6]. The Commission will facilitate coordination of these activities.

AI Based Application Success Predictor

1️⃣ Strong, Mission-Aligned Impact (Most Important Across EC Calls)

The EC is impact-driven: proposals must show how the project will:

Solve a major European or global societal challenge

Deliver measurable, lasting benefits for EU citizens

Produce outputs that can be used by policymakers, industry, or society

Align with Horizon Europe missions, priorities, and strategic agendas

Predictor: Clear, quantifiable, EU-level impact → strongest scoring factor.

2️⃣ Clear, Ambitious, but Achievable Objectives

Successful proposals show:

2–4 well-defined objectives linked to the Work Programme call text

Clearly articulated research questions or innovation goals

Logical, realistic expected outcomes and deliverables

Feasible scientific and technical approaches

Predictor: Balanced ambition + feasibility.

3️⃣ Excellent, Cutting-Edge Science or Innovation

For RIA/IA/CSA or ERC-level grants, reviewers expect:

High novelty and innovation

Strong grounding in current state-of-the-art

Clear advancement beyond existing approaches

Solid theoretical or experimental foundations

Robust methodological design

Predictor: Scientific excellence is essential for competitive scoring.

4️⃣ Strong Consortium with Complementary Expertise

EC proposals are consortium-driven (except ERC/EIC Accelerator).

High-scoring consortia:

Cover all needed competencies (science, industry, policy, ethics, dissemination)

Include SMEs, industry partners, NGOs, and public bodies when relevant

Are geographically diverse across EU Member States and Associated Countries

Demonstrate strong leadership and communication structures

Predictor: Well-constructed consortium with clear roles.

5️⃣ Clear Pathway From Outputs → Outcomes → Impact

Evaluators look for a credible trajectory showing:

How research leads to specific outputs (data, tools, prototypes)

How outputs lead to uptake or use

How use produces societal, economic, scientific, or policy impact

Strong Key Performance Indicators (KPIs) and impact metrics

Predictor: Clearly mapped impact pathway.

6️⃣ Strong Implementation Plan (Work Packages, Deliverables, Gantt Chart)

Winning proposals have:

Well-designed Work Packages (WPs) with clear scope and responsibilities

Interdependencies identified and risk-mitigation strategies

Detailed milestones and deliverables

Feasible budget aligned with tasks

Strong project management plan

Predictor: High implementation quality boosts the “Excellence” and “Implementation” scores.

7️⃣ Policy Relevance and Contribution to EU Strategies

Especially critical for health, climate, digital, and social calls.

Proposals score higher when they link to:

EU Cancer Mission

EU Green Deal

Digital Europe strategy

EU Biodiversity Strategy

EU Health Union & One Health

Open Science & FAIR data mandates

Predictor: Clear alignment with EU policies.

8️⃣ Strong Stakeholder & Citizen Engagement (Especially in Social & Health Missions)

EC values inclusivity:

Patient groups

Civil society organizations

Public sector bodies

Regulatory agencies

Citizen science components

Stakeholder letters of intent or commitment strengthen credibility.

Predictor: Engagement adds impact and relevance.

9️⃣ Robust Data Management, Open Science, and Ethics

Mandatory components include:

FAIR Data Management Plan

Open access publications

Ethics self-assessment

GDPR compliance

Data security, governance, and ethical approvals

Animal-use reduction and justification (if applicable)

Predictor: Clear compliance with ethical and data obligations.

10️⃣ Well-Justified Budget and Resource Allocation

Budget must be:

Proportional to tasks

Transparent and reasonable

Efficiently distributed among partners

Free from padding or unjustified costs

Predictor: Realistic budgets improve Implementation scores.

🚫 COMMON PITFALLS THAT LEAD TO EC GRANT REJECTION

Pitfall	Why It Fails
Weak connection to Work Programme text	Immediate score reduction
Vague or generic impact statements	Poor Impact score
Overly ambitious, unrealistic scope	Feasibility concerns
Poorly structured consortium	Low Implementation score
No policy relevance	Weak strategic alignment
Lack of concrete KPIs or outcomes	Impact unclear
Weak data or ethics plan	Eligibility/score penalties
No exploitation or dissemination plan	Insufficient impact credibility
Budget misalignment	Reviewer distrust

Specialties

Cancer

Immunology

Clinical Trials

Eligibility Requirements

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.

Sponsor Details

Sponsor Institute/Organizations: European Commission

Sponsor Type: Corporate/Non-Profit

Address: Berlaymont Building, Rue de la Loi 200, 1049 Brussels

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