Support IICT Call

Support for submissions to the SNSF Investigator-Initiated Clinical Trials (IICT) program

The Investigator-Initiated Clinical Trials program of the Swiss National Science Foundation is a funding scheme targeting clinical researchers who wish to conduct a multicenter randomized-controlled trial which is beyond the normal Swiss National Science Foundation project funding scheme in terms of its research question, comprehensive nature, duration, complexity, and costs. More information about the program can be found on the program website. The whole process follows a five-step approach (for details see below):

  1. Call for proposals
  2. Submission of a letter of intent
  3. Submission of full proposal
  4. Rebuttal to written peer reviews
  5. Decision by an independent panel

Preparation of the grant proposal is also different to the preparation of a proposal for normal project funding i.e., involves more people including the public or patients, requires more time, and additional preparatory work. The Department of Clinical Research encourages clinical researchers to consider a submission and supports submissions for this funding scheme.

Due to the number of submissions each year and the amount of work and time required to prepare a high-quality proposal; we ask applicants to follow the below described process. Otherwise, we cannot guarantee appropriate support and even might not be able to support an application at all. Please also take note, that you must contact us until April 14th if you plan to submit a proposal. Otherwise, we cannot guarantee appropriate support.

Idea

Develop the project idea and discuss with colleagues. The program is dedicated to large, multicenter randomized-controlled trials. The majority of participants should be enrolled within Switzerland (with some exceptions) at more than two sites but non-Swiss sites are allowed. The intervention to be tested can be treatment(s), preventive intervention(s), screening procedure(s), or diagnostic(s). Previous budgets ranged from a few hundred thousand CHF to 3.4 Mio. Treatment costs are eligible e.g., for the production of the Investigational Medicinal Product.

Non-randomized, pilot, or proof-of-concept trials are not eligible as well as observational or preclinical studies.

 

Summary

Once the project idea has become clear, we suggest to draft:

  1. A summary based on the PICO scheme (Population, Intervention, Control, Outcome(s))
  2. A first version of the trial flow chart
  3. A rough study schedule table

This serves for further discussions and to clarify the main objectives.

Contact DCR

Once you have the summary ready it is time to contact the Department of Clinical Research for a first discussion (consulting). To do so, please send an e-mail with all what you have so far (especially summary, draft flow chart and study schedule)

     until  April 14th, 2024 latest
     to  info.dcr@unibe.ch

Otherwise, we cannot guarantee appropriate support and even might not be able to support an application at all.

Consulting

During the first consulting session, we will discuss the study question, trial design aspects, and feasibility as well as whether the project fits to the call.

Based on the number of project ideas, DCR support for proposal development can vary.

Letter of Intent

A letter of intent has to be submitted to the Swiss National Science Foundation until May 27th. The letter needs to use the dedicated template. The letter itself is not peer reviewed. Its primary purpose is to facilitate selection of peer reviewers by the Swiss National Science Foundation and to allow a formal eligibility check of the applicants. Therefore, the general study population and the experimental interventions to be evaluated are fixed, once the letter is submitted. Other aspects such as the sites, the sample size, or the budget are only indicative and can be adapted in the full proposal.

If a clinical trials unit is involved and planned to act as partner, a letter of support must also be submitted.

CV

A curriculum vitae must be prepared using the dedicated template of the Swiss National Science Foundation. More information can be found on the CV website. If you have not used the format so far, plan for enough time to enter all the information on the website (no Word template or similar). We suggest to do it at least 10 days before submission deadline.

PPI Preparatory Grant

Active involvement of patients, members of their family, carers, the public, or the relevant patient organizations (Patient and Public Involvement) is mandatory across the entire lifecycle of the project (development, set-up, conduct, and completion). To allow for appropriate planning of these activities, Swiss National Science Foundation provides a preparatory grant of up to CHF 5,000. The grant covers Patient and Public Involvement activities for developing the full proposal including the plan for activities over the course of the project.

The preparatory grant proposal is primarily a budget justified by a patient engagement plan. The budget can cover compensation of 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 organization of meetings for PPI activities can be charged to this grant.

The proposal is not sent out for peer reviewer but is evaluated by the Swiss National Science Foundation internally to ensure that formal requirements are met.

Submission LoI & PPI

The Letter of Intent and the PPI Preparatory Grant proposal have to be submitted to the Swiss National Science Foundation until May 27th, 2024 17:00 via mySNF (not the SNSF Portal).