Best Practices in the Management of Investigator Initiated Trials: Structure, Activities and Responsibilities

As the number of investigator initiated trial (IIT) submissions continues to rise, it is important for biopharmaceutical companies to properly vet each proposal and approve the ones that demonstrate scientific merit and align with corporate objectives.

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 structure, activities, responsibilities, leadership, SOPs, proposal evaluation and review process.

This study serves as a reference point for pharma leaders who oversee or work in investigator-initiated trials so that they can compare the critical aspects of their IIT program with those of industry peers.


KEY TOPICS

• IIT Submission Review and Systems
• Functional Involvement
• Important Criteria for IIT Evaluation
• Key Reasons for Rejecting IIT Proposals

• What type of IIT studies does your organization support?
• What is the involvement of various functions during proposal collection and initial screening of the IIT process?
• What is the level of position of the IIT operational team lead?
• Do you have written SOPs for IIT processes?
• How frequently does the IIT review committee meet?
• What role do MSLs play in IIT management?
• What are the most important criteria when evaluating an IIT proposal?
• How do you review concept proposals on a rolling basis or within a submission window?

• Strategic fit and scientific merit most often determine IIT approval; high costs and strategic misalignment lead to IIT denials
  • The most used criteria for evaluating new IIT proposals were “strategic fit” and “scientific value.”
  • Some companies also evaluate based on “clinical feasibility” and “potential impact.” IIT denials occur most often because of strategic misalignment and high costs.

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.

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.