Support to Nordic clinical research projects
The Nordic Trial Alliance (hereafter NTA) is a pilot project jointly funded by the Nordic Council of Ministers (NCM) and NordForsk for the period from 2013-2016. The NCM funding stems from the programme "Sustainable Nordic Welfare - Infrastructure for Welfare" which aims to identify new, innovative solutions to renew the Nordic welfare systems. For more information on the official Nordic cooperation, see www.norden.org
It is essential to increase access to research infrastructure and join forces to make the most of our combined national skills and resources if the Nordic region is to continue to maintain its strong position in the international arena. Nordic health cooperation on trials in new therapies and drugs has great potential for increasing the quality of health care and enhancing patient safety and health in the Nordic region.
The overall aim of the NTA is therefore to expand Nordic cooperation on clinical multi-centre trials. Increased Nordic cooperation in clinical research will lead to a rise in the number of joint clinical trial operations, thus boosting the attractiveness of the Nordic countries as partners in research. Such activities will also promote knowledge transfer as well as increased efficiency and output.
The Nordic Trial Alliance aims to:
- establish a Nordic collaboration platform with the aim of supporting multi-centre clinical studies in the Nordic countries;
- establish an organisational structure that includes the key environments for clinical studies in the Nordic countries;
- attract research networks, environments and partners to the Nordic network;
- initiate development projects in priority areas, such as gap analysis, ethical issues and legal issues.
The NTA will also seek to provide industry support to promote links to relevant researchers and networks as well as disseminate information about the benefits of conducting clinical trials in the Nordic region. The NTA will invite patient organisations to take part in the project to enable them to remain informed and provide input to the sub-projects.
In June 2013, the NTA issued a call for proposals focusing on the implementation of NTA aims with an application deadline of 20 September 2013. More information on funded projects will be presented at nta.nordforsk.org early 2014.
Thematic framework of the call
The number of clinical studies, i.e. studies of the effects of a drug or treatment, has declined in the Nordic countries over the past years. This may have a negative impact on the health care sector, and, among other things, increase the time it takes for new methods and treatments to be introduced to patients.
The Nordic Trial Alliance (NTA) project aims to reverse this negative trend by coordinating support to existing and developing Nordic networks in clinical research and by providing researchers with information on where to find relevant research infrastructure. The NTA also aims to identify and provide solutions to obstacles that prevent or impede Nordic research cooperation.
This call for pilot projects is part of the array of support functions that will be provided to Nordic studies by the NTA. The present call aims to support ongoing Nordic clinical research projects or expansion of ongoing national projects into Nordic ones.
The proposed study should encompass an area of high interest and medical need for patients in the Nordic countries, for which a study at the Nordic level will lead to benefits beyond those of a single country study, e.g. a disease in a vulnerable population, in the area of individualised medicine or rare diseases, or targeting an area in which a positive study outcome may change the conditions for Nordic patients with an endemic disease.
Funding will be granted for Nordic research collaboration as specified in the proposal. The funding can be used to fund researchers and research groups at academic institutions and research institutes in the Nordic countries or for other costs associated with the proposed project.
As the funded project should be able to report within the NTA project period, the proposed total time frame for a project should not exceed two years.
The total available funding for this call is 6 MNOK for one to two projects. Each project may apply for up to 4 MNOK.
Processing of proposals
The application must be submitted in electronic format via the NordForsk application portal no later than 21 March 2014. Decisions are to be announced at the end of June, 2014.
The final funding decision will be taken by the NordForsk board based on a recommendation by the NTA board following external peer review performed by an international referee panel.
The referee panel will provide written feedback to the NTA Secretariat. The outcome of the application will be communicated to the applicants via the NTA Secretariat, who will initiate contract negotiations with the approved project/s and their host organisations shortly thereafter. The projects granted funding are expected to launch their activities during autumn 2014.
NordForsk's Guidelines on Impartiality will be applied in order to avoid conflicts of interest in the prioritisation and funding decisions.
- In order to be eligible for funding within this call, a proposed study should have been initiated in at least one Nordic country.
- The funded project should have partners from a minimum of three Nordic countries (Denmark, Finland, Iceland, Norway, Sweden or the autonomous areas of Faroe Islands, Greenland and Åland Islands).
- The Project Leader should be an established senior researcher based in one of the Nordic countries. The formal applicant must be an institution or other research-performing legal entity based in one of these countries. NordForsk will enter into a contract with this institution, which will be responsible for the administration of the project. This is also the legal entity to which NordForsk will disburse the grant.
- The funded project must have binding institutional commitment from at least three Nordic countries. Letters of intent are required from all partners in the proposal stage.
- Proposals must include an overall budget detailing the anticipated costs of the project and a specification of how these costs will be distributed among the various collaborating partners. All project partners must document their own contribution (cash and in-kind) to the principal and formal applicant institution.
- Proposals must include a description of the frameworks and procedures needed to perform the research (protocol), including the approval obtained by the applicant from a separate external scientific evaluation body/granting committee, an ethical committee and when applicable from a national Competent Authority.
- Proposals must describe gender perspectives relating to the research and the organisation of the project.
The quality of the project will be assessed based on the following components:
- Relevance of the research plan (protocol) in relation to fulfilling NTA aims (relevance relative to the call for proposals, originality and novelty of research, feasibility and expected results, appropriateness of budget, potential for knowledge transfer and use of knowledge to other areas, potential for long-term cooperation beyond the funding period). Data quality is expected to be assessed by adhering to ICHGCP, including systems for monitoring, reporting and audits when needed.
- Competence of personnel (scientific merits; leadership of clinical trials; experience and skills related to management) in preparing, running and reporting the clinical study.
- The assessment of the research plan includes an assessment of the feasibility of the proposed budget describing the total costs and overall funding contributions to the project, including the impact of the funding requested from the NTA.
- The project must already have been subject to scientific assessment (e.g. for previous funding) and approval by relevant authorities in at least in one Nordic country. One possible reason for the application may be to implement the study in more than one Nordic country to expand the possibility of rapid patient recruitment.
- If the study includes countries outside the Nordic region, the number of participating Nordic countries must be in majority, and a description must be provided of how the NTA funding will be monitored to ensure its intended use.
- Added value of the Nordic cooperation including justification as to why the project should be carried out as a joint Nordic effort and how the results will benefit the Nordic countries
- If two proposals are judged equal, priority will be given to projects of greater impact on public health.
Examples of projects of interest are those including new drugs, new indications for existing drugs, development of new medical devices, studies utilising tissue banks, or registry studies, and in particular those evaluating the introduction of new treatments. Evaluation of new treatments and new methods including new or revised surgical procedures is also of relevance.
The sponsor for the study is assumed to be of public origin, e.g. a university hospital or a regional hospital. Joint applications with shared public-private sponsorship are welcomed. Priority will be given to applications where private partners fulfil the criteria for small and medium enterprises (Recommendation 2003/361/EC: SME Definition). The SME or private investment in the project must be detailed in the application. The NTA grant cannot exceed the SME investment.
As the NTA is a three-year pilot project ending April 2016, it is necessary that the study is up and running in at least one Nordic country at time of application. The number of patients already recruited should be specified in the application (including date for the measurement) and the total number estimated to be included should also be stated, if relevant.
The successful applicant/-s will be expected to provide short written reports on the progress of the study every six months, and to be available for oral presentation at least once a year at the NTA stakeholder meeting. In addition to monitoring the research project, the progress reports will also be used to identify obstacles preventing or impeding cross-border Nordic collaboration. A final report must be delivered to the NTA within 3 months from the completion of the project. If a funded project runs beyond March 2016, an additional status report should be submitted at the latest by March 2016.
An application should include proof of scientific review (e.g. original grant decision), a full protocol with enclosures (e.g. case record forms or e-forms), copies of relevant approvals from the ethical review board and medicines agency (when applicable), the budget including other funding, a statement on the size (in terms of employees) of any private partner (SME) and an accompanying letter explaining how the grant will be used and the benefits that will be achieved by the project if the grant is approved.
Management and organisation
NordForsk will sign a contract with the host institution where the Project Leader is employed, and this contract will set out the specific funding rates and details. The grant will be disbursed to this institution and a consortium agreement regulating the rights and obligations of the various institutions involved in the project must be drawn up. Performance of the project will be monitored through scientific progress reports submitted every six months. A final report should be submitted to the NTA Secretariat at NordForsk after the end of the funding period. This final report is to include the scientific report and a financial report.
The Project Leader will be responsible for the implementation of human resource strategies for researchers in line with the basic principles of the EU Charter for Researchers and the EU Code for the Recruitment of Researchers.
Maximum applied amount (NOK): 4.000.000
NTA project leader, Pierre Lafolie
Responsible advisor at NordForsk
Senior Adviser Maria Nilsson
Phone: +47 99 38 02 64