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

With the biopharmaceutical industry utilizing investigator-initiated trials (IITs) to increase the breadth of clinical programs, it is critical that organizations don't let costs leapfrog results.

Thus as companies accelerate their IIT programs, it is important that they appropriately resource and effectively manage communications with investigators.

Best Practices, LLC undertook this benchmarking research to provide a detailed roadmap for improving IIT management at bio-pharmaceutical companies, capturing critical metrics and insights on IIT management team staffing, budget and communication. This study also identifies the top challenges and future improvements to IIT management process.


KEY TOPICS

• 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?
• 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?
• Does your company require publication (abstract or peer review manuscript) as a condition for final milestone payment?
• What are the top challenges to IIT management process?
• How do you plan to improve your IIT management process?

• Companies are requiring more frequent IIT updates
  • Cycle times are shrinking for key IIT categories, such as (1) protocol review to protocol decision; (2) protocol decision to contract negotiation start, and (3) contract execution to first patient in study.
  • The percent of company staff fully dedicated to IIT management has risen by 30% from 2017 to 2020, which may partially explain how IIT cycle times are being compressed.
    

Best Practices, LLC engaged 46 leaders from 34 bio-pharmaceutical and medical device companies in this research through a benchmarking survey. Nearly three-fourths of the respondents serve at the director level or above.

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