Investigator initiated clinical trials (IICT)

Support for investigator initiated clinical trials

The IICT programme is targeted at researchers who wish to conduct an investigator initiated clinical trial. Support will be given to trials that are of value to the patients and address important unmet medical and societal needs but are not in industry focus.

Applicants must submit a letter of intent (LOI) via mySNF by 5 p.m. Swiss local time on 25 May 2021. The platform will be open to researchers as of 1 April 2021.

  • Details

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    The programme for Investigator Initiated Clinical Trials (IICTs) of the Swiss National Science Foundation (SNSF) offers targeted support for clinical studies that are of value to the patients and address important unmet medical and societal needs. These studies are designed and conducted according to the highest international standards.

    Clinical trials are defined in the Federal Act on Research involving Human Beings (Human Research Act, HRA)* and regulated by the Ordinance on Clinical Trials in Human Research (Clinical Trials Ordinance, ClinO)**.

    IICT studies go beyond the scope of project funding in terms of their research questions, comprehensive nature, duration, complexity and costs. They generally require a multicentric setting, sometimes international collaborations, and are not in the industry focus.

    Excluded from support under the IICT programme are:

    • Non-randomized and uncontrolled studies
    • Pilot studies, proof of concept studies
    • Studies with safety endpoints only
    • Observational studies
    • Preclinical studies
    • Studies conducted for direct commercial purposes

    * Clinical trial means a research project in which persons are prospectively assigned to a health-related intervention** in order to investigate its effects on health or on the structure and function of the human body.

    ** Health-related intervention means a preventive, diagnostic, therapeutic, palliative or rehabilitative measure investigated in a clinical trial.

  • Participation requirements

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    ​Applicants

    Natural persons are eligible to submit applications if they meet the general eligibility requirements for the submission of applications pursuant to Arts. 10 and 12 of the Funding Regulations and Arts. 4 and 5 of the Regulations on Project Funding and if they form a research group pursuant to Art. 12 of the Funding Regulations.

    The members of the research group must have an excellent scientific track record over several years and the ability to lead a clinical study involving various experts and institutions in a multicentric setting.

    The research group consists of a maximum of 5 persons. The members of the research group have clearly defined roles and responsibilities with regard to the implementation of the project as a whole.

    The members of the research group appoint a corresponding applicant (Art. 12 para. 4 of the Funding Regulations); this person is generally the leader of the clinical study.

    ​Project partners

    Project partners are researchers who contribute to a research project through cooperation without being responsible for the project. In a clinical research context, project partners may be, for instance, researchers who contribute to the inclusion of patients in recruiting centres. They must be designated as such in the application. Within the scope of their contributions, such as analyses etc., project partners benefit from the SNSF grant. However, they do not count as (remunerated) employees of the project and are not among those responsible for the project as a whole. They may not refer to the support received from the SNSF as a grant they have themselves acquired.

  • How To

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    Deadlines

    The deadlines for the call 2021 are:

    • Submission of letters of intent via mySNF on 25 May 2021 until 5 p.m. Swiss local time (for details see: 5.3 Formal requirements, item a). The platform will be open to researchers as of 1 April 2021.
    • Submission of full proposals via mySNF on 1 November 2021 until 5 p.m. Swiss local time. Applications must be submitted via the mySNF platform ("Programmes", "Investigator Initiated Clinical Trials"). The platform will be open to researchers as of 1 July 2021.

    Please note that the opening of a new mySNF account can take up to 5 days.

    For further information, please refer to the call document.

    Patient and public involvement

    In the research plan, applicants must document their efforts and plans to actively involve patients, members of their family, carers, and the public in the design and delivery of the project. If no patient or public involvement was or will be possible, the reasons need to be outlined in the research plan.

    For example, patients, members of their family, carers and members of the public may work with researchers to:

    • Help select research that is important
    • Devise relevant research questions
    • Identify outcomes that matter most to patients
    • Design studies so they are easier to take part in
    • Develop clear information about research studies
    • Help create plain English summaries of studies
    • Co-produce consent forms
    • Make sure communication is sensitive and appropriate for participants
    • Help collect research data, for example through interviews
    • Analyse research findings from a patient perspective
    • Raise awareness amongst the public of what research is taking place
    • Share findings of important research
    • Help make sure research is reported in understandable ways
    • Be part of a research project steering group

    Providing open access to research data

    All clinical trials funded through the IICT programme must be registered and trial protocols made publicly available before the first participant receives an intervention. After completion of the study, appropriately anonymised datasets have to be made available for further analysis wherever possible.

    Recruiting centres

    Recruiting centres must confirm their participation in writing. These confirmations (letters of commitment) form part of the application to be submitted on the mySNF portal and consist of the following items:

    • Confirmation of participation in the trial (giving the title of the trial and PI's name)
    • Name and position of the person responsible for patient recruitment;
    • Number of patients that will be included in the trial at the centre;
    • Evidence for the feasibility of patient numbers, e.g. experiences made in previous studies, patient registers or retrospective case studies.

    The letters of commitment must be written in English. The SNSF accepts PDFs sent as e-mail attachments if they include the information set out above.

    Evaluation procedure

    Proposals that meet the personal and formal requirements and that are not manifestly inadequate will be evaluated by an international panel including experts and members of the public.

    For further information, please refer to the call document.

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