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 20 May 2022. The platform will be available to researchers as of mid-April 2022.
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)*.
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.
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
- NEW: 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.
***i.e. different setting, greater sample size, more relevant endpoint
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 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.
- The deadlines for the call 2022 are:
- Submission of letters of intent via mySNF on 20 May 2022 until 5 p.m. Swiss local time. The platform will be available to researchers as of mid-April 2022.
- Submission of full proposals via mySNF on 1 November 2022 until 5 p.m. Swiss local time. The platform will be available to researchers as of 1 July 2022.
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.
NEW: after submission of the letter of intent, a preparatory grant for patient engagement of up to CHF 5000 can be requested. This grant aims to support activities during which patient representatives can provide input for the development of the grant application/protocol. The budget must be outlined in a patient engagement plan and must include compensation of the patient 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 patient involvement activities can be charged to this grant.
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
All clinical trials funded under the IICT programme must be registered and trial protocols made publicly accessible on a trial registry (SNCTP portal as well as on any WHO primary registry or ClinicalTrials.gov) before the first participant receives an intervention. After completion of the study, appropriately anonymised datasets must be made available for further analysis wherever possible.
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.
Call for proposals
Templates and instructions