IICT Grant Partnering

• Start by discussing your project concept with colleagues including assessing its feasibility and relevance. Questions include:
  • Is it about a clinical decision that matters for patients and clinicians?
  • Are you aware of all evidence in context (via systematic searchers, including a check of registries such as  ClinicalTrials.gov for potential ongoing studies)
  • Is it clearly without an industry-driven agenda?
  • Does it fit in the SNF IICT scope?
  • Is preliminary feasibility confirmed (population, sites, timeline)?

• Also check your eligibility for the grant on the program website.

• Contact DCR for a consultation, ideally using the project enquiry form. We recommend reaching out in January or February to make the most of our partnering support. Last-minute requests cannot be supported. 

Also consider enrolling in the DCR Grant Writing Program for Clinicians to ensure you are in the best position for the next steps,

How DCR can support you:

• By providing expert assessment and advice on adequacy and relevance of the project idea for the IICT program

• The Letter of Intent and full proposal, along with all related administrative data must be submitted in mySNF. All co-applicants must also create a mySNF account if not already done.

N.B.: Account activation can take up to one week, so allow sufficient time.

• For all co-applicants, a curriculum vitae must be prepared using the dedicated template of the Swiss National Science Foundation using their SNSF portal. More information can be found on the CV website. If you have not used the format before, plan enough time to enter all the information on the website.

The Letter of Intent (LOI) is a non-binding pre-proposal that outlines the main idea of your planned project. It helps the SNSF prepare for the evaluation process and will provide initial feedback on whether your application meets formal requirements regarding eligibility of applicants. Changes can still be made later in the full proposal.

• Make sure to read the instructions carefully and note the key dates.
• Create your LOI using the template provided on the program website. The PPI preparatory grant needs to be prepared and submitted at the same time as the LOI (see next section).

How DCR can support you:

• Provide advice and support in completing the LOI template
• Provide a Letter of Support of DCR involvement (only provided following a consultation and provided DCR has capacity)

PPI Preparatory Grant

The SNSF will fund Patient and Public Involvement (PPI) activities during the planning phase of your project with up to CHF 5,000, regardless of whether you ultimately receive a grant. These funds cover the costs of PPI activities for developing the project proposal (July to the end of October).

• You must create a separate application for the PPI Preparatory Grant. In step 2, select the LOI as a template and this will automatically transfer the relevant information. Please note that this application will be assigned its own project number in mySNF.

The PPI Preparatory Grant application must be submitted at the same time as the LOI.

• Once the grant is approved, please notify PPI DCR as soon as possible. This applies only to PPI preparatory grants supported by DCR since their inception.

How DCR can support you:

• Guidance, review, and comments on PPI activities planning and associated budget for meaningful involvement.

For more information please see DCR PPI.

• Prepare the final application with full project details, ensuring that the perspectives of PPI contributors are included. This includes finalizing your research question and thus all methodological aspects of your project (population, intervention, control group, study design and sample size, etc.) as well as the visit plan, recruitment strategy, and data collection.
• Complete the Proposal on the SNSF template and check the IICT checklist available on the program website.

How DCR can support you:

• Regular exchange and brainstorm as needed
• Support regarding clinical study management and regulatory affairs, data management, methodology & study design, monitoring, PPI, statistics, and study conduct by CIU.
• Support with completing the Proposal template
• Critical review of the application

Research question and study design

An impactful and relevant research question starts from a thorough current state of knowledge. A systematic review of ongoing and completed clinical trials is essential to identify existing knowledge gaps and provides a strong rationale for the relevance of your proposal. It also facilitates the clear definition of the research question and informs key aspects of study design, including the selection of patient-relevant endpoints, sample size determination, and practical implementation considerations.

How DCR can support you

• Advice on high-quality trial design, including pragmatic, decentralized, and advanced approaches
• Support systematic reviews, ensuring evidence is contextualized and actionable
• Meaningful outcome selection
• Recruitment strategies and feasibility assessment

Sample size calculation

Sample size is critical in designing a robust study and for the feasibility and success of a clinical trial. The sample size must be carefully justified, including a clear explanation of the clinical rationale and statistical assumptions underlying the calculation.

To perform the sample size calculation, you will need the following:

• The primary endpoint, clearly specified
• The anticipated variability (variance) of the outcome
• The effect size of interest

How DCR can support you:

• Provide rigorous sample size planning
• Support you in clarifying plausible assumptions informing the statistics

Please note that defining the research question and study design, as well as estimating the sample size, are often developed through an iterative collaborative process over several weeks, involving experts in biostatistics, data science, and clinical epidemiology.

• Please plan accordingly and reach out to DCR as soon as possible.

PPI activities

Your proposal must reflect how you have involved patient and public contributors in its development, from the identification of the research questions to designing the study, through to the PPI activities planned. This also includes defining how you plan to involve contributors throughout the remaining life cycle of your project including the design of the study, its management and conduct, data analysis, dissemination of results, and the final evaluation.

How DCR can support you:

• Assist with constituting the study PPI panel and facilitating PPI contributors training
• Organizing, completing and documenting preparatory PPI activities
• With advice and support in planning and budgeting PPI implementation throughout the next phases of your project

For more information please see DCR PPI.

Logistics and collecting offers

Especially for trials with drugs (investigational medicinal product; IMP) or medical devices, you will need to explore different supply options. Please be aware that manufacturing the study medication, including the blinding of active treatment and placebo, may influence the regulatory classification and feasibility of the study. It is therefore important to assess the feasibility of producing the study medication at an early stage.

• The grant can cover these costs, but they can be expensive and budgets may be complex
• Plan for logistics around blinding and delivery of IMP to trials sites.

How DCR can support you:

• Identify suppliers and support in the discussions and negotiations with them.
• Identify logistic requirements and how to fulfil them.
• Identify options for decentralized approaches.

Contacting potential trial sites and collection of a Letter of Commitment

• Reach out to potential trial sites as early as possible and ensure feasibility of recruitment.
• Collect letters of commitment from all participating sites identified as project partners (or co-applicants). The letter must contain evidence of the site-specific enrolment potential. This evidence can come from pilot studies, previous trials (of similar population and interventions) or extracts from the data warehouse of the hospital/institution (preferably multiple sources). Simple statements about enrolment potential are not sufficient.

How DCR can support you:

• Guidance and support on assessment of recruitment feasibility.

Budget

The budget for the SNSF IICT call is considerably more detailed than many other funding schemes.

• Be sure to allocate sufficient time for entering your project into mySNF and carefully review the specific requirements, as these may vary from year to year.
• Previously prepared budgets should not be assumed to be directly reusable.
• In addition, all budget items must be thoroughly justified.

How DCR can support you:

• Leverage our expertise in preparing grant budget
• Provide a budget adapted to your study including support from DCR on clinical study management and regulatory affairs, data management, monitoring, PPI, statistics, study conduct by CIU
• Provide guidance in budgeting PPI contributors activities

Submission

• Make sure you have the following information:
  • All required standardized CV from co-applicants
  • Letters of Commitment from all the participating centers and project partners (where relevant)
  • All administrative details for project partners (including dates of birth)
• Request Letters of Support from your PPI panel

How DCR can support you:

• Provide a Letter of Commitment detailing our partnership with you

• Double check the SNF IICT checklist available on the program website.
• You are now ready to submit.

For the SNSF IICT call, all proposals that meet formal requirements (as checked by SNSF internally) are sent out for international peer review. You will typically receive at least four written peer reviews, one of which is from a biostatistician and another from a patient expert.

• You will typically receive the outcomes of the peer review from the SNSF in early March. 
• You must provide a letter of rebuttal within two weeks.

The date for receiving the feedback will be announced early. As soon as it is known, we highly encourage you to schedule a meeting with DCR. Once you receive the feedback, please forward it to DCR ahead of the meeting.

• Your rebuttal should be a point-by-point discussion of the elements raised by the peer reviewers. No changes to the proposal are possible at this stage, and the rebuttal can only clarify misunderstandings or provide further explanations and justifications for certain design choices.

How DCR can support you:

• Feedback and discussion on the points raised by reviewers
• Critical review of the rebuttal letter

The decision of which proposals were successful is usually announced in late June or early July. Please inform DCR as early as possible of the outcome of your proposal whether it was accepted or declined.

Acceptance

If your project is funded by SNSF, the official start of the funding period must be between July of the decision year and June of the following year. Be aware that activities (e.g., drafting the trial protocol or other documents) can be started even before the official start of the funding period if you have sufficient resources.

• The partnership with DCR will then be formalized and a start date agreed upon.

Rejection

If your proposal is declined, you have the option to resubmit. Note a resubmission still requires completing the whole submission process again, from LOI to the full proposal.

How DCR can support you

• Debrief and improvement strategy
• Planning resubmission or alternative funding