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Investigator-Initiated Trials:
Building Superior IIT Capabilities (PH114)

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Published 2008
169 pages
400+ Metrics
100+ Charts and Diagrams

  Overview

Companies Metrics Content

Call Oveda Slade at 919-403-6583 to learn more about investigator-initiated trial (IIT) management departments, processes, and strategy.
 
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

 


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