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Products & Services Medical Affairs Clinical Trials

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

ID: 5709


Features:

5 Info Graphics

18 Data Graphics

240+ Metrics

4 Narratives


Pages/Slides: 34


Published: 2021


Delivery Format: Online PDF Document


 

License Options:


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  • STUDY OVERVIEW
  • BENCHMARK CLASS
  • SPECIAL OFFER
Non-members: Click here to review a complimentary excerpt from “Best Practices in the Management of Investigator Initiated Trials in Oncology: Resource Allocation, Communication and Future Prospects”

STUDY OVERVIEW

With oncology companies 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 conducted this benchmarking research to provide a detailed roadmap for improving IIT management within oncology companies, capturing critical metrics and insights on IIT management team staffing, budget, future improvements and challenges.

KEY TOPICS

  • IIT Funding
  • Future Improvements
  • Challenges

KEY METRICS
  • 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?

SAMPLE KEY FINDINGS
  • 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.

METHODOLOGY

Best Practices, LLC engaged 18 leaders from 15 oncology organizations in this research through a benchmarking survey. More than three-fourths of the benchmark respondents serve at the director level or above.

Industries Profiled:
Medical Device; Pharmaceutical; Manufacturing; Biotech; Consumer Products; Diagnostic; Health Care; Biopharmaceutical; Clinical Research; Laboratories


Companies Profiled:
Becton Dickinson; Bayer; Cipla; Daiichi Sankyo; Eisai; EMD Serono; Guerbet; Ipsen; Jazz Pharmaceuticals; Karyopharm Therapeutics; Merck; Sandoz; Sanofi; Solidfarma; Takeda Pharmaceuticals

If you purchase Best Practice Database document(s), you will have 30 days from the date of purchase to apply some or all of the cost of the document(s) toward the cost of a Full Access Individual, Pharma, Group or University Membership. Write us at DatabaseTeam@bestpracticesllc.com or call David Guinn at 919-767-9179 if you have any questions.