Clinical trials with an industrial and/or commercial purpose will not be considered!
- 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 agreement (before project start) between the researcher and the industrial partner ensuring the researcher full ownership of obtained data and the rights to publish independently of the industry sponsor.
- 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.
- If an application for the clinical trial previously has been unsuccessfully applied for at the Novo Nordisk Foundation, it is imperative that it is described how the application has been improved since last submitting the proposal.
- 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.
- The main applicant (investigator) must have a MD and must be a specialist physician or at a similar level. 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.
The budget frame for each grant is from DKK 5 million to DKK 20 million over a period of 3–5 years. The grant capital in 2023 is DKK 80 million.
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.
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.