Practices and Attitudes of Swiss Stakeholders Regarding Investigator-Initiated Clinical Trial Funding Acquisition and Cost Management

Key Points Question What are the practices and attitudes of Swiss stakeholders regarding funding acquisition and cost management in investigator-initiated clinical trials (IICTs)? Findings In this qualitative study, including interviews of 48 IICT stakeholders, respondents reported that they lacked experience and expertise in the budgeting of IICTs. A lack of responsibility for the quality assurance of this task was also identified. Meaning These findings suggest that there is a need for empirical and transparent data on IICT costs, including budget monitoring and calculation tools, which may help avoid further conflict among stakeholders and promote adequate funding for IICTs.


Primary investigators interview guide
1. To start, could you tell me a bit about the types and how many clinical trials you have conducted? a. Were these single or multi-center clinical trials? …. 4. Did you consider conducting a pilot clinical trial or other feasibility work?
a. If yes, did you actually do it? How did you fund it? b. If no, why not? 5. When you are planning a clinical trial, how do calculate the budget? a. Did you get help with calculating the budget (e.g. from a Clinical Trial Unit)? b. Did you use a budget calculation tool? i. If yes: Which calculator did you use? How satisfied were you with the tool? What were the strengths and weaknesses of the tool? What could be done to improve the tool?
ii. If no: Did you use your own template or did someone else (e.g. from a CTU) calculate the budget for you? What were the strengths and limitations of the approach you used? c. Did you consider empirical cost data from a similar clinical trial when calculating the budget?
i. If yes, from where did you get the empirical cost data? 6. What is important to you when calculating the budget for a clinical trial? What would the ideal procedure and ideal budgeting tool include? 7. What were the main challenges to fund the trial? a. Where did the funds for your clinical trial come from? (proportion for each funding source) b. Did you have the clinical trial "fully funded" when recruiting the first patient into the clinical trial? i. Do you think the Swiss funders have a policy of fully or only partially funding clinical trials? Does this influence how much funding you request? c. Did you have to compromise on any aspects of your clinical trial because of funding limitations? What did you compromise on/sacrifice? d. What would you estimate was the proportion/total of "hidden costs"? That is, work you had to do that isn't reimbursed/funded e.g. feasibility work, resource use that was necessary to write the protocol and/or funding proposal, discussions with peers or reviews by experts, or establish a trial team/network? 8. How did you monitor costs during the trial? Did you use any tool?
a. If yes, which tool did you use? How satisfied were you with the tool? What are the strengths and weaknesses of the tool? What could be done to improve the tool? b. If no, did someone else (e.g. from a CTU) monitor resource use and costs for you? Would you like to have a tool available? What functions should such a tool have? 9. From your experience, are the actual costs of an RCT often higher or lower than the estimated/planned costs or mostly on budget?
a. If costs are higher, what were in your view the reasons for that? 10. In general, what do you think are the main cost drivers of a clinical trial? From your experience where could/should costs be saved? 11. In general, what would you suggest to facilitate/improve the acquisition of funds for clinical trials in Switzerland?
Funding agencies interview guide 1. To start, could you tell me a bit about the types and how many investigator-initiated clinical trials applications you receive each year? a. How many of these are single or multi-center clinical trials?