menu
https://novonordiskfonden.dk/da/grants/investigator-initiated-clinical-trials/

Investigator Initiated Clinical Trials

Investigator Initiated Clinical Trials

Area
Biomedicine and health sciences
Place of research
Denmark
Amount
Up to DKK 20 mio. per grant
Recurring call
Expected February 2021
Call opens
February
05
2020
Deadline
June
16
2020, 2pm (14:00 CEST)
How to apply Apply
Call opens
05 Feb 2020
Deadline
16 Jun 2020, 2pm (14:00 CEST)
How to apply
Amount
Up to DKK 20 mio. per grant
Announcement of results:
Mid-December 2020
Apply

Purpose

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 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.

Eligibility

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 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.
  • All 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.
  • 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.

Main applicant:

  • The main applicant (investigator) must be a specialist physician 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.

Funding

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 2020 is DKK 80 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

Please read ‘Information and guidelines for applicants Investigator Initiated Clinical Trials 2020’ carefully before initiating the application process. Additional and essential information is found in these guidelines.

The application and any additional uploads must be written in English and completed using the internet-based application system.