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