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市場調查報告書
研究者主導型臨床實驗（IIT：Investigator Initiated Trial）：製藥公司的活用
Investigator-Initiated Trials: Building Superior IIT Capabilities
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研究者主導型臨床實驗（IIT：Investigator Initiated Trial）：製藥公司的活用 是由出版商Cutting Edge Information在2008年04月所出版的。
這份英文市場調查報告書包含169 pages 價格從美金4995起跳。
此報告書調查分析了關於製藥公司的IIT管理集團的合作，並且彙整了IIT與企業戰略的調整、IIT提案的評價•認可的比較分析•最佳執行，以及IIT管理的改善、IIT管理現況、成為標竿的構造•投資資料，還有16家製藥企業關於IIT的合作等。報告書之內容摘要如下所示。
第1章 IIT的戰略性作用
- IIT成果的自我評價
- 贊助廠商的臨床實驗與IIT分享
- 使用IIT成果的部門
- 被公佈出來的經認可IIT分享
- IIT的益處
- 在開發方面的IIT分享
- 用於IIT管理集團的自我識別改善領域
第2章 IIT選定過程的概要
- IIT申請評價過程的圖表
- IIT認可路線：評價•認可•公告提案的分享
- 領取•評價•認可提案的分享
- IIT提案的領取過程圖表
- IIT提案的收集•接受：持有既有過程的企業之分享
- IIT提案的追蹤過程：持有既有過程的企業之分享
- 到達最終認可的領取提案的比例
- IIT認可的時間線明細
- IIT認可的審查過程
- 從提案領取到決策組織為止的時間
- 正式的IIT提案委員部門
- 從決策組織到最終認可為止的時間、等
第3章 IIT的基盤架構
- 擁有IIT專業集團的企業
- 沒有IIT專業集團的企業明細
- IIT專業功能的FTE
- 擁有領取•評論•認可IIT提案的正式委員會的企業
- 正式的IIT提案委員部門
- 提出正式的IIT提案委員部門的數量
- 領導IIT提倡的行政部門等級
- IIT提案最終認可的委員1人•委員會全體的決定力
- 管理IIT結果的部門
- 管理IIT結果的部門數、等
第4章 IIT計畫的概況
- 16家公司在IIT上的合作
- 管理基盤架構
- IIT份量
- 生產性•管理
- 影響•改善
封面圖片： 
Abstract
Establish and perfect internal controls to capitalize on IIT opportunities
Investigator-initiated clinical trials (IITs) provide companies with the
clinical data to further scientific understanding of their drugs. IIT findings
help to expand on- and off-label usage, reach new patient populations,
generate data for publication and solidify relationships with key opinion
leaders. Once considered an afterthought, IITs are now often regarded as
critical pieces of product development strategy.
Reflecting this different mindset, many companies have established centralized
IIT management groups and processes. While such efforts mark a giant step
forward, all organizations still routinely confront challenges that range from
slowdowns in the IIT-approval process to issues with trial oversight.
Investigator-Initiated Trials addresses such obstacles and provides solutions
by outlining steps to refine IIT management efforts. Use this report to
accomplish the following goals:
- - 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
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
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