Call for proposals
The national programme for clinical therapy research in the specialist health service, KLINBEFORSK, shall contribute towards giving Norwegian patients improved opportunities to participate in clinical trials and is set up as a contribution to implementation of the strategy plan HelseOmsorg21. The call is open to all clinical disciplines; however, it should focus on meeting needs and close knowledge gaps that are of the greatest importance to patient treatment.
The Norwegian regional health authorities jointly announces a call for applications for funding of clinical multicentre studies with the aim of improving existing treatment procedures and/or developing or evaluating new regimens. The total budget available for 2020 is approximately 140 mill. kroner, with an allocation of up to 50 mill. kroner towards «needs-identified research» for a study programme for personalised/precision medicine in cancer treatment. All projects funded by KLINBEFORSK should include participation from clinical research groups in all four health regions, provide equal inclusion opportunities for all Norwegian patients and user involvement.
Applications should be submitted using the electronic platform: eSøknad.
For 2020, specific guidelines have been developed for:
NB! New deadline for all applications: June 30th 2020, 16:00.
Who may apply?
Applications must be put forward by health institutions or private, non-profit hospitals given access to funding from the regional health authorities (cfr. list of institutions). Other private institutions with access to regional funding cannot act as an applicant institution, but may participate in the projects as collaborating partners.
The principal investigator (applicant) and main collaborating partners (at least one per health region) should hold at least a 20% position in an applicant institution at the time of application and throughout the project period.
Any individual principal investigator may only submit one application to KLINBEFORSK; however, he/she may contribute as a collaborating partner in several projects.
A person over the age of 70 may not apply to KLINBEFORSK. If an applicant reaches this age during the project period, the applicant institution should submit a written statement describing how the project will be handled with a new PI.
Funding will not be awarded more than once to any main project within one and the same project period.
A. Project applications to KLINBEFORSK (Open call)
Projects are supported by KLINBEFORSK for a period of up to five years. The budget should be within the range of 5-20 million NOKs for the entire project period. Budgets should be realistic and described in detail.
Costs arising from the implementation of the research project may be covered by the KLINBEFORSK grant, however, expenses incurred by ordinary treatment of patients should be covered by the hospitals / institutions themselves.
Support for recruitment of patients is limited to Norwegian patients only.
Establishment of a national research network may be included as an integral part of the project.
Priority: In the open call for projects from KLINBEFORSK in 2020, priority will be given to applications related to comparative studies of intensive habilitation of children / adolescents with brain damage, provided that the projects are of sufficient quality. The priority follows from a decision made by the KLINBEFORSK programme board October 14th, 2019.
Available budget items
- Academic positions: PhD duration of 3 FTEs;
positions may be taken as 50 – 100% employment during the project period.
- postdoctor, researcher or medical personnel.
- Support personnel (e.g. research coordinator, research nurse etc.)
- Operating costs, including production of medicinal products and materials
- Services purchased from research support units, including additional infrastructure costs for implementation of the projects (e.g. monitoring, data handling, eCRF etc.)
- Costs to cover user involvement
Funding to cover the indirect costs of an institution such as rent, electricity, maintenance, administrative support etc., is not available through the programme.
Requirements for applications to KLINBEFORSK
- The application and all attachments should be written in English.
- The project should be affiliated with and managed from an institution with access to funding (cfr. list of institutions).
- The project should have partners from all four health regions with affiliation with at least one of the specified institutions in each region. Project partners should be listed in the application form.
- Mandatory attachments:
- Project description, max. 10 pages (see template).
- CV and list of publications for the principal investigator and main collaborating partners from each of the three other regions (max. 5 pages for each participant).
Other attachments should not be included in the application and will not be evaluated.
B. Applications for funding for needs-identified research (sketches)
KLINBEFORSK should seek to cover knowledge needs and gaps of great importance for patient care. To achieve this goal, the tool «needs-identified research» has been implemented, bringing input from knowledge summaries and established systems such as Nye Metoder into the program. For the 2020 call, the regional medical directors, via Nye Metoder, have identified a need for research on structured, experimental treatment of patients with metastatic cancer.
The program board for KLINBEFORSK has decided, based on the input, to allocate up to NOK 50 million kroner of the 2020 call for a study program dedicated to personalized medicine / precision medicine in the cancer field.
Applications for research funding for such study programs shall fulfill the intention of the program plan. Applicants are also asked to include the following points:
- Equal access for patients from all health regions should be facilitated in accordance with guidelines fprovided by the Ministry of Health and Care Services and KLINBEFORSK’s programme plan. Criteria for patient inclusion that safeguard such access rights shall be described.
- The study program requires collaboration with industry, e.g. with contributions of medicines and coverage of additional costs for patient inclusion. The industry partnership must be described, including opportunities for industrial collaboration related to both diagnostics and treatment.
- Cooperation with key partners beyond the pharmaceutical industry, such as the Cancer Registry, should be described.
Requirements for the application
- The project description and all attachments must be written in English. The project description should provide an outline of the project within a time frame of up to five years (sketch, maximum 5 pages).
- The project must be led by an eligible institution (cf. the list of applicant institutions) with approval from the .
- The project should have partners in all four health regions from at least one of the specified eligible institutions. Partners should be listed in the application form.
- CV with publication list for project manager and key partners from each of the three other regions (maximum 5 pages per participant)
The project outline will describe a study protocol that takes into account the guidelines for allocation to needs-identified research. A national organization for the study program will also be described.
Applications (project sketches and attachments) for funding in the needs-identified research call will be evaluated by international experts. In addition, the programme board will evaluate the strategic orientation of the applications. The programme board will also conduct a dialogue with the applicants before invitations to submit a complete application are given. The date for completion of the complete application will be set after this dialogue. Assessment of complete applications will be conducted as described for ordinary applications to the KLINBEFORSK open call.
General requirements for applications
User involvement is mandatory for all applications to KLINBEFORSK. Recruitment of patients from all health regions should be facilitated, and the projects must include active, clinical research collaborations between hospitals or private, non-profit hospitals in all four health regions. The collaborations must comply with established regulations awarding co-authorships (Vancouver convention). Roles, tasks and responsibilities should be stated clearly for all researchers / research groups participating in the project, and the application should describe how a national collaboration will bring added value.
The projects should preferably make use of dedicated infrastructure, e.g. NorCRIN. It is assumed that the projects will use system resources (such as eCRF solutions) that meets relevant legal requirements. A project may be part of an international network/collaboration provided that the Norwegian branch of the project takes on a central role.
Projects may include collaborations with pharmaceutical industry, provided that the project is promoted by an applicant institution and meets the needs of the patient and the specialist health care service. Any contributions from industry should be described in detail in the project description and in the budget module.
Each project should be managed by one project manager/principal investigator only and affiliated with a single responsible institution. The participating institutions should set up a joint agreement regulating their contributions, privileges and responsibilities prior to the start of the project.
NB! It is not permitted to submit applications with identical or very similar project descriptions. If this is the case, these applications may be rejected.
Applications to KLINBEFORSK must be submitted using the regional health authorities’ joint electronic platform – eSøknad.
Applications that do not meet the above requirements will be rejected.
In case of any discrepancies between the Norwegian and English versions, the Norwegian version takes precedence.