Investigator-Initiated Trials: Building Superior IIT Capabilities

Published by: Cutting Edge Information

Published: Apr. 1, 2008 - 169 Pages

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

Abstract

• Develop strategic thinking to align IITs with corporate strategy
• Compare timelines and best practices for IIT proposal evaluation and approval
• Improve ongoing IIT oversight
• Discover IIT management trends
• Benchmark structures and investments
• Examine profiles of 16 companies' IIT efforts

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