Best Practices in the Management of Investigator Initiated Trials in Oncology: Resource Allocation, Communication and Future Prospects

• IIT Funding
• Future Improvements
• Challenges

• Please specify the number of FTEs dedicated to IIT management at your company
• What was your total budget for IIT management in the last fiscal year ($USD)?
• How many IITs were included in your total budget in the last fiscal year?
• What are the methods of budget forecasting for your IIT program?
• What functions provide financial support to IITs?
• Where do oncology companies spend money from their IIT budgets?
• What are the allowable indirect cost rates (in %)?
• Does your company pay for fringe benefits on salary? If yes, then what is the allowable percentage on salary do you pay? If no, then how do you manage budgets with fringe benefits request?
• If there are multiple Investigators submitting similar proposals, does your organization allow introducing these Investigators to each other in case they may be interested in collaborating?
• What determines milestone payments for clinical IITs?
• What is the payment milestone used for IITs?
• What percentage of IITs generated publications in the last year?
• Does your company require publication (abstract or peer review manuscript) as a condition for final milestone payment?
• What is the preferred channel for receiving IIT updates at your company?
• How frequently are IIT updates received?
• What is the extent of feedback does your IIT committee provide to the investigators after the concept submission review?
• Looking forward over the next 24-36 months, what do you expect will be the trend regarding the IIT funding?
• Does your organization invite investigators onsite to present on their study findings after their study is complete, or does your organization have an ‘IST Day’?
• What are the top challenges to IIT management process?
• How do you plan to improve your IIT management process?

• Streamlining the process is most cited future improvement that those involved in IIT management at oncology companies would like to see: Optimizing resources and training stakeholders would help in managing IIT process.

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