RFPs: Investigator Initiated Clinical Trials Grant Programme (Denmark)

Deadline: 18-Aug-2026

The Investigator Initiated Clinical Trials Grant Programme supports larger non-commercial clinical trials in Denmark that aim to improve patient treatment through new medicines, technologies, and better clinical routines. Funding ranges from DKK 6 million to DKK 22 million per project for three to five years, with a total programme allocation of DKK 89 million. Eligible applicants must be specialist physicians with an MD, employed at the Danish hospital where the project is anchored, and serving as principal investigator.

Overview

The Investigator Initiated Clinical Trials Grant Programme is seeking applications to strengthen opportunities for conducting larger clinical trials in Denmark.

The programme supports non-commercial clinical trials involving patients and aims to improve treatment routines, patient care, and clinical outcomes.

Funding is available for monocentric trials, multicenter national trials, and certain international multicenter trials coordinated from or involving Denmark.

Purpose of the Programme

The purpose of the programme is to support larger investigator-initiated clinical trials that have no commercial purpose.

The programme aims to improve patient treatment by testing or evaluating new medicines, technologies, and treatment routines.

It supports trials that demonstrate strong clinical relevance, high scientific quality, and clear potential to improve care for patients.

Key Focus Areas

The programme focuses on non-commercial clinical trials, investigator-initiated research, patient treatment, innovative medicines, medical technologies, existing treatment routines, monocentric trials, multicenter national trials, international multicenter trials, Good Clinical Practice, randomized controlled trials, non-randomized trials, data sharing, clinical relevance, and high scientific quality.

What the Programme Supports

The programme supports larger clinical trials involving patients.

Supported trials may include:

• Monocentric clinical trials in Denmark
• Multicenter national clinical trials
• International multicenter clinical trials coordinated from Denmark
• Danish participation in international studies coordinated outside Denmark
• Randomized controlled trials
• Non-randomized clinical trials
• Trials testing new medicines
• Trials evaluating new technologies
• Trials improving existing treatment routines
• Trials designed to improve patient care and clinical quality

All projects must be non-commercial and focused on patient benefit.

Funding Amount

Funding ranges from DKK 6 million to DKK 22 million per project.

The total funding allocated to the programme is DKK 89 million.

Applicants should request a budget that matches the scale, duration, trial design, patient recruitment needs, data management, and implementation requirements of the project.

Project Duration

Projects may run for three to five years.

Applicants should prepare a realistic project timeline that covers trial preparation, approvals, recruitment, intervention or follow-up, data analysis, reporting, and dissemination.

Eligible Trial Types

The programme supports several types of clinical trials.

Eligible trial types include:

• Larger non-commercial clinical trials
• Monocentric national trials
• Multicenter national trials
• International multicenter trials coordinated from Denmark
• Danish components of international trials coordinated outside Denmark
• Randomized controlled trials
• Non-randomized trials

The trial must involve patients and must aim to improve treatment or clinical practice.

International Trial Requirements

International multicenter trials are eligible when the coordinating investigator and the trial are anchored at a hospital in Denmark.

For international studies coordinated outside Denmark, funding may only be requested for the Danish part of the project.

In such cases, the Danish applicant must have a key role in the trial.

Applicants should clearly explain Denmark’s role, the Danish trial sites, the responsibilities of the Danish investigator, and the added value of Danish participation.

Good Clinical Practice Requirement

All funded trials must comply with Good Clinical Practice guidelines.

Good Clinical Practice supports ethical and scientifically sound clinical research involving patients.

Applications should show how the trial will maintain quality, safety, documentation, monitoring, data integrity, and patient protection throughout the project.

Required Application Components

Applications must include a strong and complete clinical trial package.

Required elements include:

• Detailed clinical trial protocol
• Power calculation
• Data management plan
• Statistical analysis plan
• Description of clinical relevance
• Description of scientific quality
• Trial design and methodology
• Patient recruitment strategy
• Good Clinical Practice compliance plan
• Project budget
• Timeline and milestones
• Data sharing plan through public repositories
• Description of principal investigator experience
• Scientific and financial reporting responsibilities

The application should be detailed enough to demonstrate feasibility, quality, and patient benefit.

Data Sharing Requirement

The programme encourages data sharing through public repositories.

Applicants should describe how trial data will be managed, stored, protected, and shared where appropriate.

A strong data management plan should address:

• Data collection
• Data quality control
• Data security
• Patient confidentiality
• Public repository use
• Long-term access
• Compliance with relevant regulations
• Responsible data sharing

Who Is Eligible?

Eligibility is limited to main applicants who meet specific professional and institutional requirements.

The main applicant must:

• Hold a medical degree
• Be a specialist physician
• Be employed at the Danish hospital where the project is anchored
• Serve as the principal investigator
• Demonstrate documented experience in research leadership
• Demonstrate substantial research activity
• Take responsibility for scientific reporting
• Take responsibility for financial reporting

The applicant must have the capacity to lead a large clinical trial and manage the scientific and administrative responsibilities of the grant.

Who Is Not Eligible?

Applicants who do not meet the main applicant requirements are not eligible.

Ineligible applicants may include:

• Applicants without an MD
• Applicants who are not specialist physicians
• Applicants not employed at the Danish hospital where the project is anchored
• Applicants who will not serve as principal investigator
• Applicants without documented research leadership experience
• Applicants without substantial research activity

The programme is designed for experienced clinical researchers with the authority and capacity to lead major investigator-initiated trials.

Existing Grant Holders

Researchers who already hold an active grant under the Investigator Initiated Clinical Trials programme may submit a new application during the final year of the existing grant.

However, the existing and new grant periods must not overlap.

Applicants in this situation should clearly explain the timing of the current grant and the proposed new project.

Why It Matters

Large non-commercial clinical trials are essential for improving patient care, testing treatment routines, and generating evidence that may not be driven by commercial interests.

These trials can help determine whether medicines, technologies, or clinical practices improve outcomes in real healthcare settings.

This programme matters because it strengthens Denmark’s capacity to conduct high-quality investigator-led clinical trials that directly support better treatment, stronger evidence, and improved quality of care.

How to Apply

Applicants should prepare a complete clinical trial application that demonstrates eligibility, scientific quality, clinical relevance, feasibility, and compliance with Good Clinical Practice.

Step 1: Confirm Applicant Eligibility

The main applicant must be an MD, specialist physician, and principal investigator employed at the Danish hospital where the trial is anchored.

The applicant should also confirm documented research leadership experience and substantial research activity.

Step 2: Define the Clinical Trial Question

The proposal should clearly explain the clinical problem and research question.

The trial should aim to improve existing treatment routines, test new medicines or technologies, or generate evidence that can improve patient care.

Step 3: Choose the Trial Design

Applicants should describe whether the trial is monocentric, multicenter national, international multicenter, randomized, or non-randomized.

The trial design should be appropriate for the research question and patient population.

Step 4: Prepare the Trial Protocol

The protocol should include detailed information on:

• Background and rationale
• Objectives
• Trial design
• Patient population
• Inclusion and exclusion criteria
• Intervention or exposure
• Comparator, if relevant
• Outcomes
• Recruitment plan
• Follow-up plan
• Safety monitoring
• Ethical considerations
• GCP compliance

Step 5: Prepare the Power Calculation

The application must include a power calculation.

This should justify the sample size and show that the trial is designed to answer the research question with appropriate statistical strength.

Step 6: Prepare the Data Management Plan

Applicants must explain how trial data will be collected, stored, protected, managed, and shared.

The plan should also address public repository use where relevant.

Step 7: Prepare the Statistical Analysis Plan

The statistical analysis plan should describe how trial results will be analysed.

It should include primary and secondary outcomes, analysis methods, handling of missing data, subgroup analysis where relevant, and interpretation strategy.

Step 8: Prepare the Budget

Applicants may request between DKK 6 million and DKK 22 million.

The budget should reflect the trial’s scale, duration, patient recruitment, data management, personnel, monitoring, and other necessary costs.

Step 9: Demonstrate Clinical Relevance and Scientific Quality

The application should clearly explain why the trial matters for patients and clinical practice.

It should show how the study can improve treatment, care quality, or healthcare decision-making.

Step 10: Submit the Application

Applicants should submit the completed application with all required documents, including the protocol, power calculation, data management plan, statistical analysis plan, budget, and information on applicant qualifications.

Selection Considerations

Applications are likely to be assessed based on clinical relevance, scientific quality, feasibility, and applicant capacity.

Key assessment areas may include:

• Strength of the clinical research question
• Potential to improve patient treatment
• Non-commercial purpose
• Quality of trial design
• Good Clinical Practice compliance
• Strength of the protocol
• Validity of power calculation
• Quality of data management plan
• Quality of statistical analysis plan
• Feasibility of recruitment and implementation
• Principal investigator qualifications
• Research leadership experience
• Budget realism
• Data sharing plan
• Relevance to Danish clinical care

Tips for a Strong Application

Applicants should:

• Present a clear patient-focused research question
• Demonstrate strong clinical relevance
• Ensure the trial has no commercial purpose
• Prepare a detailed and rigorous protocol
• Include a justified power calculation
• Provide a strong statistical analysis plan
• Explain GCP compliance clearly
• Show realistic recruitment capacity
• Demonstrate strong research leadership
• Justify the budget carefully
• Include a clear data sharing plan
• Explain Denmark’s role in international trials, if applicable

Common Mistakes to Avoid

Common mistakes include:

• Applying without meeting the MD and specialist physician requirements
• Not anchoring the project at a Danish hospital
• Submitting a weak or incomplete trial protocol
• Missing the power calculation
• Missing the data management plan
• Missing the statistical analysis plan
• Not explaining Good Clinical Practice compliance
• Proposing a trial with unclear patient benefit
• Providing weak evidence of research leadership
• Requesting funding outside the DKK 6 million to DKK 22 million range
• Not clarifying the Danish role in international trials
• Submitting a new application while existing grant periods would overlap

FAQ

1. What is the Investigator Initiated Clinical Trials Grant Programme?

It is a funding programme that supports larger non-commercial clinical trials in Denmark aimed at improving patient treatment, clinical routines, and care quality.

2. How much funding is available per project?

Projects may receive between DKK 6 million and DKK 22 million.

3. What is the total programme funding?

The total funding allocated to the programme is DKK 89 million.

4. How long can projects last?

Projects may run for three to five years.

5. Who can apply?

The main applicant must hold an MD, be a specialist physician, be employed at the Danish hospital where the project is anchored, and serve as principal investigator.

6. Are international trials eligible?

Yes. International multicenter trials are eligible if coordinated from Denmark and anchored at a Danish hospital. For trials coordinated outside Denmark, funding may only be requested for the Danish part, and the Danish applicant must have a key role.

7. What documents must the application include?

Applications must include a detailed protocol, power calculation, data management plan, statistical analysis plan, and information demonstrating clinical relevance, scientific quality, and applicant capacity.

Conclusion

The Investigator Initiated Clinical Trials Grant Programme provides major support for larger non-commercial clinical trials that can improve patient treatment and clinical practice in Denmark. With funding from DKK 6 million to DKK 22 million over three to five years, the programme supports high-quality monocentric, multicenter national, and eligible international clinical trials anchored in Danish hospitals. Applicants should submit rigorous proposals with strong clinical relevance, Good Clinical Practice compliance, a detailed protocol, power calculation, data management plan, statistical analysis plan, and clear evidence of principal investigator leadership.

For more information, visit Novo Nordisk Foundation.