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.
- The clinical trials must conform to good clinical practice guidelines (GCP).
- Clinical relevance and scientific quality is imperative, and a detailed protocol including calculation of power, data management plan, and plan for statistical analysis of data must be included.
- The project must be anchored at a hospital in Denmark and must be led by a specialist physician.
- Any clinical trial that receives a grant from the Novo Nordisk Foundation must be registered at ClinicalTrials.gov or clinicaltrialsregister.eu (EudraCT).
- 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.
- The main applicant (investigator) must be a specialist physician employed at the hospital where the project is anchored.
- The main applicant must have documented experience in research leadership and well-documented research activities.
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 2018 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.
For the full description of eligibility and requirements for the application please thoroughly read: ”Information and guidelines for applicants – Investigator Initiated Clinical Trials 2018”.
The application must be submitted in English and completed using the internet-based application system.