Developing the full proposal is labor intensive. It not only requires dozens of working hours but also time for repeated discussions and networking activities. The Department of Clinical Research can support you in various activities.
Writing of the full proposal
Writing the full proposal usually requires more work than the standard project grant proposal. Therefore, plan enough time and start early! Department of Clinical Research provides support for writing grant proposals. We also have templates for specific parts of the proposal. For those, you do not need to write anything, this will be done by us. Responsibilities will be defined once the letter of intent is submitted.
Please do not forget that it is important to document how the Patient and Public Involvement activities in the development of the full proposal influenced the proposal.
Patient and Public Involvement activities
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 organizations 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). During the development of the full proposal, activities focus on two main areas:
- Getting input to the clinical trial itself
- Developing a Patient and Public Involvement activities plan for the project
The Department of Clinical Research will support you in these activities.
Sample size calculation and statistical study design
Sample size is often critical for the feasibility and success of a clinical trial. The Department of Clinical Research can provide you with the appropriate sample size calculation. Note that this is usually not a one-off calculation but rather an iterative process where we provide several scenarios and where changes to the design (can) happen. The amount of work varies a lot, from a few hours too dozens of hours. Please take this into account.
Contacting potential trial sites and collection of Letters of Commitment
Start very early to contact potential trial sites. They will need to provide a letter of commitment. The letter must contain evidence for 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!
Logistics and collecting offers (especially in case of trials with medicinal products)
Especially for trials with medicinal products (medical devices), explore different options for the supply. The grant can cover these costs. Placebo production can be expensive, so different suppliers should be approached. You will need formal offers for the submission. We can help identifying suppliers and support you in the discussions with the suppliers.
Budget
The budget for the IICT Call is different to the normal project funding budget. It has much more details. Plan enough time for entering in mySNF. Applicants can ask for money to employ personnel. We suggest that this is restricted to personnel for management and coordination of the project. Costs related to participants care should be budgeted as “patient fee”, usually also for the site of the applicants. Patient fees can also be paid to non-Swiss sites. The budget must be split in yearly tranches. These are primarily of relevance for the administration/accounting of the Swiss National Science Foundation. If in doubt, budget activities rather too early than too late. The budget for CTU activities requires a special format. We provide this to you. Department of Clinical Research will support you in the development of the budget including the justification for the patient fee (which is required).