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 17:00 Swiss local time on 27 May 2024. The platform will be available to researchers as of mid-April 2024. In addition, together with the submission of the letter of intent, a preparatory grant for patient engagement during the development of the application (PPI preparatory grant) of up to CHF 5000 can be requested.
Details
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 and regulated by the Ordinance on Clinical Trials with the exception of Clinical Trials of Medical Devices (Clinical Trials Ordinance, ClinO)* and the Ordinance on Clinical Trials with Medical Devices (ClinO-MD).
The IICT programme goes beyond the scope of SNSF project funding in terms of its research questions, comprehensive nature, duration, complexity and costs. The trials generally require a multicentric setting, sometimes international collaborations, and are not in the industry focus.
Included are randomised controlled trials (RCTs) such as:
- Treatment trials
- Prevention trials
- Screening trials
- Diagnostic trials
- Quality of life trials
- Adaptive trials (i.e. platform trials)
- Repurposing trials
- Replication trials with significant knowledge gain
Excluded from support under the IICT programme are:
- Studies conducted for direct commercial purposes
- Non-randomised and uncontrolled studies
- Pilot studies
- Proof of concept studies (phase I and phase IIa)
- Studies with safety endpoints only
- Observational studies
- Preclinical studies
* 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
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. 3 and 4 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, patient representative, researchers who contribute to the inclusion of patients in recruiting centres, statisticians or CTU representatives. 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
Deadlines
The deadlines for the call 2024 are:
- Submission of letters of intent via mySNF by 27 May 2024, 17:00 Swiss local time
- If applicable, submission of PPI Preparatory Grant applications via mySNF by 27 May 2024, 17:00 Swiss local time
- Submission of full proposals via mySNF by 1 November 2024, 17:00 Swiss local time.
Patient and public involvement (PPI)
In the research plan, applicants must document their efforts and plans to actively involve patients, members of their family, carers, the public or the relevant patient organisations across the entire lifecycle of the project (from the design of the study to its management and conduct, data analysis, dissemination of results and final evaluation). For more information on PPI, please refer to the SCTO webpage.
Together with the submission of the letter of intent, a preparatory grant for patient engagement during the development of the application (PPI preparatory grant) of up to CHF 5000 can be requested. This grant aims to support activities during which PPI representatives can provide input for the development of the grant application/protocol. The budget must be outlined in a patient engagement plan and can include compensation of the PPI representatives for the time spent on providing input, as well as reimbursement of travel costs and expenses for accommodation and meals. In addition, the costs associated with the organisation of meetings for PPI activities can be charged to this grant.
Note: maximum duration 01.07.2024 - 31.10.2024 (4 months)
After checking the formal requirements, the SNSF Administrative Offices directly award these preparatory grants.
Clinical trial unit involvement
The involvement of a clinical trial unit (CTU) is highly recommended. You are advised to contact your local CTU as early as possible. If a CTU is involved, a letter of support describing its involvement must be submitted together with the letter of intent as well as the full proposal.
Providing open access to research data
From an ethical and public health perspective, but also in view of an efficient use of research resources, it is essential that clinical trials are conducted in an open and transparent manner and that the findings are made available to the whole research community and society. As required by the Swiss regulations (Clinical Trials Ordinance, ClinO) and based on the WHO Joint statement on public disclosure of results from clinical trials, the SNSF expects that the requirements described under article 8.4 of the call (PDF) are met.
Recruiting centres
Recruiting centres must confirm their participation in writing. These confirmations (letters of commitment) are of central importance for assessing the feasibility of the study and must include 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 to 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.
Guidelines for CV and major achievements
The SNSF has signed the “San Francisco Declaration on Research Assessment (DORA)”, which recommends funders to be explicit about the criteria used in evaluating the scientific productivity of applicants. The scientific quality, value and impact of the entire research output is taken into consideration (including datasets, software, prototypes) in addition to research publications. In this context, the scientific content of a paper is much more important than publication metrics or the name of the journal in which it was published. Within the scope of this evaluation, the scientific discipline and the academic age (incl. career breaks, care duties, etc.) of the applicants will be considered.
In order to comply with the DORA principles, the SNSF defined a new structure for the CV and requests a standardised set of information from all applicants.
Specifically, applicants will have to compile their CV according to a new template on the SNSF-Portal and subsequently upload a PDF in the data container “CV and major achievements”.
You find more information on the CV website and on the SNSF-Portal.
This information, which must be provided each applicant and written in the language of the research plan, is sent out for peer-reviewing.
Documents
Call for proposals
Templates and instructions
- Checklist (PDF)
- IICT 2024 Letter of Intent Template (Word)
- IICT 2024 Proposal Template (Word)
- Template for CTU Services (Word)
- Template for CTU Services (Excel)
- Template for scientific reports (Word)
- Template "Letter of commitment" for patient representatives (Word)
- SPIRIT 2013, explanation and elaboration: guidance for protocols of clinical trials (PDF)
- DMP – Guidelines for researchers
Regulations
Supplementary measures
News