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Call: Nordic Clinical Trial Projects on Paediatric Cancer Treatment


The submission deadline for this call has passed
Application deadline
03.10.2018 13:00
Background

NordForsk, the Norwegian Cancer Society and the Research Council of Norway are collaborating to fund research in the area of personalised cancer treatment for children. The call will be announced as a Nordic Trial Alliance activity under the Nordic Programme on Health and Welfare.

The overall objective of the Nordic Programme on Health and Welfare is to improve health in the Nordic countries by finding solutions to societal and public health challenges through high-quality research. The Nordic Trial Alliance (NTA) project is entering its second phase, and is working to expand Nordic cooperation on clinical multi-centre trials. During 2017-2019, the NTA will focus on the use of real-world data to support the development and implementation of personalised medicine.

Increased Nordic cooperation in clinical research will raise the number of joint clinical trials, thus boosting the attractiveness of the Nordic countries as partners in research. These activities will also promote knowledge transfer as well as increased efficiency and output. The NTA seeks to identify and provide solutions to obstacles that prevent or impede Nordic research cooperation.

Who is eligible to apply?

Researchers and research groups at universities, hospitals and other research-performing institutions in the Nordic countries are eligible to apply for funding. The Nordic countries are defined here as Denmark, Finland, Iceland, Norway, Sweden, Aaland Islands, Faroe Islands and Greenland. The formal applicant must be an institution, organisation or other legal entity based in one of the Nordic countries.

Joint applications with shared public-private sponsorship are welcomed, however, applicants should note that private companies are not eligible to receive NordForsk funding.

Thematic framework

The call target is paediatric cancer treatment. Every year, several hundred children and young people in the Nordic countries are diagnosed with cancer, and there is a need for new knowledge to further develop satisfactory treatment services. There is a need for solutions that not only ensure higher survival rates but also facilitate good quality of life for children after completed treatment.

The expanding field of genomic medicine has empowered personalised cancer treatment. This entails giving each patient treatment that is more specifically customised to his or her individual biological characteristics. Not everyone with the same type of cancer should necessarily receive the same treatment - instead, the biological conditions will determine the treatment regime.

When treatment is more personalised, the patient groups become smaller. As a result, each Nordic country on its own often has too small a patient base to conduct national trials. However, the Nordic countries together can provide a solid foundation for numerous types of research of high international scientific value. By joining forces, the Nordic countries can become an attractive arena for new trials and treatment regimes. Paediatric medicine is an area with ongoing disciplinary cooperation that would clearly benefit from increased Nordic cooperation.

This call for projects aims to support Nordic researcher projects in cancer medicine or expansion of ongoing national projects into Nordic ones. A study at the Nordic level should lead to benefits beyond those of a single country study. The study should exemplify personalised paediatric cancer treatment and user perspectives should be taken into account.

Projects of interest may focus on e.g. new drugs, new indications for existing drugs, new personalised applications of old treatments, and development of new medical devices. Evaluation of new treatments and new methods including new or revised surgical procedures will also be of relevance.

The Nordic countries have access to a unique collection of health data information, including register and biobank data. A deeper understanding of mechanisms underlying disease can be studied using trajectories of health and social conditions throughout the life span for patients and controls. Projects supported under the call are expected to utilise data from existing Nordic health data resources (e.g. quality registers, medical records, omics and biobank data) to support the different clinical study phases.

Projects should give special attention to documenting any cross-border obstacles (including administrative hindrances and time-consuming processes) to Nordic collaboration and propose ways to overcome these.

The projects awarded funding under this call should aim to establish Nordic competence networks within clinical research on paediatric cancers. Projects are expected to set up procedures for knowledge sharing in and between the Nordic countries in order to support quality improvement in health care services for this particular patient group.

Projects awarded funding are also expected to consider cooperation with existing Nordic e-Infrastructure and paediatric medicine initiatives.

Financial framework

This call for proposals is administered by NordForsk. The total budget for this call is maximum NOK 38 million, and the maximum funding amount that may be sought is NOK 10 million. Funding will be granted for a period of three to five years.

Funding may be used for:

  • Running costs (including sample handling, drug costs);

  • Data collection, analysis and curation;

  • Research positions; study support personnel;

  • Administrative expenses related to project management;

  • Travel and mobility;

  • Meeting costs;

  • Communication and dissemination activities.

Eligibility criteria

To be eligible for funding, projects must satisfy the following conditions:

  • The Project Leader must be an established senior researcher based at a research institution in one of the Nordic countries. NordForsk will enter into a contract with this institution, which will be responsible for the administration of the research project. This is also the legal entity to which NordForsk will disburse the grant.

  • The project consortium must involve partner institutions from at least three Nordic countries. Partner institutions from non-Nordic countries must fund their own participation.

  • Proposals must include a description of the frameworks and procedures needed to perform the research (protocol). When relevant, the approvals from separate external scientific evaluation bodies/granting committees, ethical committees and, when applicable, from a national Competent Authority should be included.

  • The proposed research projects must describe how Nordic real-world data will be utilised to support the clinical trial.

  • Proposals must be submitted in English.

Other requirements:
  • Partners from private companies must fund their own participation.

  • A institutional commitment (Letter of Intent) from partners from at least three Nordic countries.

  • An overall budget detailing the anticipated costs of the research project and a specification of how these costs will be distributed among all funding sources, including funding sought from the Programme.

  • A description of the relevant legal and ethical frameworks and procedures needed to perform the research.

  • A plan for dissemination and implementation of the project results, including, if relevant, plans for market orientation.

  • A description of how gender perspectives will be incorporated into the research,and, in the case of a significant gender imbalance of the project team composition, a description of what measures will be made to improve this; please consult the NordForsk's Gender Policy.

  • A plan for how the user perspective will be taken into account in the study.

  • A plan for open access to publications in accordance with Science Europe's Principles for the Transition to Open Access to Research Publications.

  • A plan for how data quality is expected to be assessed, including systems for monitoring, reporting and audits when needed.

  • A description of how data management will be aligned with the FAIR data principles (Findable, Accessible, Interoperable, Re-usable). For guidance see Annex 1.

Assessment criteria

An international expert panel will assess the proposals on the basis of the following criteria:

  • The scientific quality of the grant proposal, including the scientific potential and quality of the project plan/study protocol, and potential to develop the Nordic paediatric cancer treatment;

  • Relevance relative to the call for proposals;

  • Competence of the Project Leader and project group, including clinical trial management (preparing, running and reporting the clinical study), scientific merits and output, academic leadership, and experience and skills related to the project;

  • Research environment including profile, cohesion, possibility for specialisation;

  • Expected results and impact, including long-term scientific as well as societal impact of the cooperation;

  • Feasibility and rigour of the project plan in relation to proposed resources (human resources, budget, schedule);

  • Involvement of user perspectives;

  • Feasibility of the proposed budget describing the total costs of and overall funding contributions to the research project, including the impact of the funding sought from the Nordic Programme on Health and Welfare;

  • Gender perspective of research and, if relevant, measures to improve gender balance of the project team composition;

  • Contribution to open science: plans as described in Annex 1, merits in the area of open science.

The Call Committee will assess the proposals on the basis of the following criteria:

  • 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;

  • Alignment with the overall goal of the Nordic Programme on Health and Welfare and the aims of Nordic Trial Alliance.

Processing of proposals

The application must be submitted in electronic format via the NordForsk application portal no later than 3 October 2018 at 13:00 CEST. No attachments are to be included unless specifically requested in the application form. In order to access the application form, applicants must register as a user on the NordForsk Application Portal and create a draft application.

Based on the assessments of the expert panel, the Nordic added value of the projects, and the balance of the project portfolio, the Call Committee will forward a recommendation of projects to be awarded funding to the NordForsk Board, which will take the final funding decision.

The final funding decision is expected winter 2018/2019.

NordForsk Guidelines on Impartiality will be applied to handle possible conflicts of interest. Applicants will be notified of the outcome of the funding decision in writing, and then NordForsk will sign contracts with the approved research projects and their host organisations shortly thereafter. Start-up of projects awarded funding is expected to take place in Q1 2019 and no later than Q3 of 2019.

Management and organisation

NordForsk will sign a contract with the host institution for the project, 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. NordForsk will not transfer any funds before the consortium agreement has been signed. Implementation of the project will be monitored through annual progress reports comprising a scientific progress report and a financial report. A final report must be submitted to NordForsk at the end of the funding period.

The Project Leader will be responsible for the implementation of human resource strategies for researchers in keeping with the basic principles of the EU Charter for Researchers and the EU Code for the Recruitment of Researchers.

Max amount of funding that may be sought (NOK million):

10

Responsible adviser:

Maria Nilsson, Special Adviser
Email: maria.nilsson@nordforsk.org
Phone: +47 99 38 02 64

Responsible adviser:

Marianne Aastebøl Minge, Senior Adviser
E-mail: marianne.minge@nordforsk.org
Phone: +47 936 02 527

Technical support

For technical support, please contact: support@nordforsk.org or +47 905 51 520

Appendices
NordForsk, Stensberggata 25, 0170 Oslo, Tlf: +47 476 14 400, E-post: support@nordforsk.org, Organisasjonsnummer: 971 274 255