Investigator-Initiated Trials: Building Superior IIT Capabilities

Table of Contents

Charts and Graphics

Chapter 1: Strategic Role of IITs

• Self-Assessment of IIT Performance
• Share of Company-Sponsored Versus Investigator-Initiated Trials
• Departments Involved in Use of IIT Study Findings
• Average Share of Approved IITs that Generate Medical Publications
• Share of Approved IITs that Generate Medical Publications (by Company)
• Average Usefulness of IITs in Accomplishing Key Objectives
• Average Share of IITs Conducted per Development Phase
• Share of IITs Conducted per Development Phase (by Company)
• Self-Identified Improvement Areas for IIT Management Groups

Chapter 2: Overview of the IIT Selection Process

• IIT Proposal Evaluation Process Diagram
• IIT Approval Pipeline: Share of Proposals that are Evaluated, Approved and Published
• Number of Proposals that are Received, Evaluated and Approved (by Company)
• IIT Proposal Receipt Process Diagram
• Share of Companies with Established Process for Collecting and Accepting IIT Proposals
• Share of Companies with an Established Process for Tracking IIT Proposals
• Percentage of Received Proposals that Reach Final Approval
• IIT Approval Timeline Breakdowns
• IIT Proposal Screening Process
• Time Spent from Proposal Receipt to Decision-Making Body
• Departments that Sit on the Formal IIT Proposal Committee
• Time Spent from Decision-Making Body to Final Approval
• Meeting Frequency Versus Average Approval Time
• Frequency of Meetings to Review IIT Proposals
• Challenges in the IIT Evaluation Process
• Time Spent from Final Approval to Notifying Investigator
• Share of Companies with an Established Process for Managing IITs
• IIT Management Process Diagram
• Contract Negotiations & Ongoing Management
• Most Problematic Aspects of the IIT Management Process

Chapter 3: Building an IIT Infrastructure

• Companies with Dedicated IIT Groups
• Breakdown of Companies without Dedicated IIT Groups
• FTEs per Dedicated IIT Management Function: Company-Wide Groups
• FTEs per Dedicated IIT Management Function: Therapeutic-Area Focused Groups
• Companies with a Formal Committee to Receive, Review and Approve IIT Proposals
• Departments that Sit on the Formal IIT Proposal Committee
• Number of Departments Sitting on the Formal Review Committee
• Level of Executive that Leads IIT Initiatives
• Single Executive Versus Committee Decision for Final Approval of IIT Proposal
• Departments Overseeing IIT Outcomes
• Number of Departments Overseeing IIT Outcomes
• Number of Departments Involved in Determining Use of IIT Study Findings
• Departments Involved in Evaluating Use of Trial Findings
• Self-Identified Improvement Areas for IIT Management Groups
• Percentage of Companies with a Dedicated IIT Budget
• Departments that Provide Funding for IIT Initiatives
• Percentage of Budget Allocated to Salaries and Overhead Expenses
• IIT Groups' Dedicated Budgets: Company-Wide
• IIT Groups' Dedicated Budgets: Therapeutic-Area Focused
• Budget Per IIT Proposal Approved
• Funds Spent on IITs by Brands with Less than $1b in Sales
• Funds Spent on IITs by Brands with More than $1b in Sales
• Forms of Support Companies Provide for IIT Investigators

Chapter 4: IIT Program Profiles

This chapter contains profiles of 16 companies' IIT efforts. The findings are presented in a series of charts and graphs for each company. Each profile follows the same structure:

• Figure 1: Management Infrastructure
  • Dedicated IIT management: budget and staffing for the company' s IIT group, if such a group exists
  • Proposal review committee: review committee membership, leadership and meeting frequency
• Figure 2: IIT Volume
  • IIT proposals: Number of proposals received, evaluated and approved
  • IITs by development stage: IIT breakdown by clinical development
• Figure 3: Productivity and oversight
  • Proposal process and timelines: average duration of IIT evaluation stages
  • Oversight and data management: groups involved in overseeing IITs and determining uses for completed studies.
• Figure 4: Impact and improvement
  • Value to objectives: impact of IITs on different company goals
  • Key improvement areas: improvement opportunities for proposal evaluation and ongoing study management