Investigator Initiated Trials Management: Structure and Resource Allocation

STUDY OVERVIEW

With the pharmaceutical industry utilizing investigator-initiated trials (IIT) to increase the breadth of clinical programs, it is important that organizations don't let costs leapfrog results. Thus as companies accelerate their IIT programs, it is critical that they appropriately resource and effectively manage their partnerships with trial leaders.

Best Practices, LLC undertook benchmarking research to provide a detailed roadmap for improving IIT management at biopharmaceutical companies, capturing critical metrics and insights on IIT management team structure, staffing and budget.

This study provides current benchmarks around IITs and management, staffing and budgets and can serve as a guide for leaders who oversee or work in investigator-initiated trials.

KEY TOPICS

• IIT Submission Review and Systems
• Functional Involvement and Responsibilities
• SOPs and Impact of IIT Process
• IIT Funding
• Challenges to IIT Management Process

KEY METRICS

• Which functions are involved in leading and supporting roles during different stages of IIT management - proposal collection and initial screening of the IIT process, IIT oversight, IIT conclusion and use of data findings and IIT publication?
• How is your IIT management group structured?
• What type of IIT studies does your organization support?
• What is most challenging part of IIT structure & management process?
• Please specify the number of FTEs dedicated to IIT management at your company
• Do you have an IIT committee that oversees the selection process?
• How many days does your IIT committee spend on IIT submission review, approval and investigator notification?
• What is the payment milestone used for IITs?
• What was your total budget for IIT management in the last fiscal year (USD)?
• What functions provide financial support to IITs?
• Looking forward over the next 24-36 months, what do you expect will be the trend regarding the IIT funding?

SAMPLE KEY FINDINGS

• Almost all Companies have SOPs Documented: 97% of the benchmark companies have SOPs documented for IIT management. 3/4th of the benchmark class state that SOPs provide roadmap, guide, and govern the process of IIT management.

METHODOLOGY

Best Practices, LLC engaged 30 leaders from 23 bio-pharmaceutical and medical device companies through a benchmarking survey. Nearly 60% of participants are at the level of director or above.

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.