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Investigator Initiated Clinical Trials

Novo Nordisk Foundation

Purpose

Please note that text and guidelines are from 2025, new and updated guidelines will be available before next application round opens!

The purpose is to strengthen the opportunities to carry out larger clinical trials in Denmark that do not have commercial purpose. The ultimate objective is to improve the treatment of patients through new medicine and new technology and to ensure the highest quality in treatment.

Grants are available for both monocentric and multicenter national trials. If applying for a multicenter international clinical trial, the coordinating investigator (main applicant) and the trial must be anchored at a hospital in Denmark. For international studies anchored outside Denmark, the grant can be applied for to cover only the part of the project carried out in Denmark, and in this case, it is key that the main applicant, who must be anchored in Denmark, has a key role in the clinical trials.

Funding

The budget frame for each grant is from DKK 6 million to DKK 22 million over a period of 3–5 years. The total grant capital is DKK 89 million.

Research fields

Applications may be submitted for most types of larger clinical trials that include patients and aim to improve existing treatment routines. Randomized controlled trials are preferred; however, nonrandomized trials are also accepted.

Application process

The application must be completed and submitted using the foundation’s electronic application system, using the link “Send application”. Link is found at the top of the page and will be visible when the call opens.

It is very important, that the applicant carefully reads the application guidelines before initiating the application process. This document contains the complete call as well as detailed instructions for the application process.

AI Based Application Success Predictor

🔬 1. Strong Alignment with Foundation Strategic Areas (Top Predictor)

NNF funding is highly aligned with its core priorities:

Biomedical & life sciences (major focus)
Cardiometabolic diseases (diabetes, obesity, cardiovascular)
Biotechnology & biosustainability
Global health & sustainability

👉 Projects outside these domains have very low success probability

🎯 2. Clear Scientific Excellence & Innovation

Successful proposals demonstrate:

High-impact, cutting-edge science
Novel hypotheses or technologies
Potential to advance fundamental understanding

👉 NNF is highly competitive and expects top-tier scientific quality

🌍 3. Demonstrated Societal & Health Impact (Critical Predictor)

Strong emphasis on:
- Improving human health
- Addressing global challenges (e.g., climate, health inequity)
Large grants require “impact upfront” planning and alignment

👉 Impact is explicitly built into evaluation frameworks

🔄 4. Translational & Innovation Potential

Preference for:
- Translational research (bench → application)
- Biotechnology innovation
- Solutions that can scale or be implemented

👉 Increasing focus on innovation ecosystems and real-world application

🤝 5. Strong Institutional & Collaborative Environment

High success rates are associated with:

Leading research institutions
International collaborations
Multi-disciplinary teams

👉 NNF frequently funds:

Research centres
Large collaborative programs

👩‍🔬 6. Investigator Excellence & Leadership Potential

Strong publication record
Proven research leadership (for large grants)
For early-career:
- Clear independence trajectory

👉 NNF funds both:

Elite senior scientists
Emerging “future leaders”

🧪 7. Feasible, Well-Structured Research Plan

Clearly defined:
- Objectives
- Methodology
- Milestones
Realistic timelines

👉 Large grants require highly structured project planning

📊 8. Ability to Build Research Capacity or Ecosystems

NNF strongly values:

Creation of:
- Research centres
- Infrastructure
- Innovation hubs
Long-term impact beyond a single project

👉 Funding often goes to ecosystem-building initiatives

🌐 9. Global & Strategic Relevance

Increasing support for:
- International collaborations
- LMIC-focused health initiatives
Expansion beyond Denmark

👉 Reflects global health and sustainability priorities

📑 10. Strong Proposal Communication

Clear articulation of:
- Innovation
- Impact
- Strategic relevance
Studies show effective “promotional framing” improves success rates

👉 Communication style influences reviewer perception

📊 Summary: Key Predictors (Ranked)

Highest impact factors:

Strategic alignment (life sciences, health, sustainability)
Scientific excellence & innovation
Societal/health impact

Moderate predictors:
4. Translational potential
5. Investigator strength
6. Collaboration & institutional quality

Supporting factors:
7. Feasibility & planning
8. Ecosystem-building potential
9. Proposal clarity

💡 Insider Insight

Compared to other funders:

Novo Nordisk Foundation is:
👉 science-driven like ERC/AACR
👉 but also impact- and innovation-focused like industry funders

👉 Key evaluation question:
“Will this research create significant scientific breakthroughs AND long-term societal impact?”

Specialties

Clinical Trials

Others

Eligibility Requirements

Clinical trials with an industrial and/or commercial purpose will not be considered!

Project:

The clinical trials must conform to good clinical practice guidelines (GCP).
Clinical relevance and scientific quality are imperative, and a detailed protocol including calculation of power, data management plan, and plan for statistical analysis of data must be included.
All clinical trials that receive a grant from the Novo Nordisk Foundation must be registered at ClinicalTrials.gov or Clinical Trials Information System (CTIS).
In case of industry sponsored material(s) there must be a written and signed agreement (before application deadline) between the researcher and the industrial partner describing the nature of sponsorship and ensuring the researcher full ownership of obtained data and the rights to publish independently of the industry sponsor. If this agreement is not uploaded before application deadline, the application will be administratively rejected!
When the clinical trial ends, the anonymized data must be made available to other researchers through public databases such as the Zenodo open data repository (CERN) or other equivalent databases.
An applicant can submit an application to the foundation before all legal approvals have been obtained, but the grant cannot be activated until all approvals from the relevant public authorities have been obtained. If a grant is not activated within one year following the date of the grant letter, the grant will be considered annulled.

Main applicant:

The main applicant (investigator) must have a MD and must be a specialist physician. Main applicant must be employed at the hospital in Denmark where the project is anchored, and he/she must be a clear driver/PI of the trial.
The main applicant must have documented experience in research leadership and well-documented research activities.
The main applicant is responsible for the project and for scientific and financial reporting.
Researchers who already hold an active grant within ‘Investigator Initiated Clinical Trials’ from the Novo Nordisk Foundation, as main applicant, are eligible to apply for a new grant during the final year of the existing grant. The grant period for the new grant cannot overlap the active grant. They can, however, be co-applicants on new projects/applications.
Employees on the project, including postdocs and PhD students cannot be co-applicants.

Eligible Countries:

Denmark

Sponsor Details

Sponsor Institute/Organizations: Novo Nordisk Foundation

Sponsor Type: Corporate/Non-Profit

Address: Tuborg Havnevej 19 2900 Hellerup

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