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医師主導治験 (IIT:Investigator Initiated Trial) の管理:承認までのスケジュールの迅速化とコンプライアンスに基づく資金管理の確立

Investigator-Initiated Trial Management: Expedite Approval Timelines and Establish Compliant Funding Practices

発行 Cutting Edge Information 商品コード 214214
出版日 ページ情報 英文 253 Pages
納期: 即日から翌営業日
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医師主導治験 (IIT:Investigator Initiated Trial) の管理:承認までのスケジュールの迅速化とコンプライアンスに基づく資金管理の確立 Investigator-Initiated Trial Management: Expedite Approval Timelines and Establish Compliant Funding Practices
出版日: 2015年02月01日 ページ情報: 英文 253 Pages
概要

医師主導治験 (IIT:Investigator Initiated Trial)の届出件数の増加により、すでに存在するIITの管理上の課題が深刻化しています。IITの最終成果は医薬品企業の手から離れたところで出されるため、IITチームによる各プロポーザルの適切かつ入念な精査が必要不可欠です。科学的メリットを示し、常に変化する企業目標と合致するIITプロポーサルを承認する優秀なチームが必要であり、また、高効率のIIT管理を行える体制が必要です。

当レポートでは、医薬品企業による医師主導治験(IIT:Investigator Initiated Trial)の効果的な管理について調査し、治験申請の選定、体制および人材配置、パフォーマンスメトリクス、コンプライアンス、コストなどにおける課題、ベストプラクティス、提言などをまとめています。

エグゼクティブサマリー

  • 医師主導治験 (IIT:Investigator Initiated Trial) 管理:成功のための提言

実施体制と人事階層によるIITプロセスの強化

  • IIT目標に基づく体制の整備
  • 適切な規模の人員配置とプログラムプロファイルの検証
  • 統合型のIIT管理戦略の実施
  • 治験成果がIITの価値を示す

IIT承認戦略・パフォーマンスメトリクスの創出

  • パフォーマンス評価のためのIITの届出およびタイムラインの追跡
  • 企業目標に向けた前進および製品データポートフォリオの強化のためのIIT承認戦略の形成
  • 承認済みIITに関するトレンド

最適なIIT予算の構築

  • IIT支出のケーススタディから学ぶ予想されるコスト

IITチームのプロファイル

このページに掲載されている内容は最新版と異なる場合があります。詳細はお問い合わせください。

目次
Product Code: PH212

As the number of investigator-initiated trial (IIT) submissions increases, existing IIT management challenges magnify. The final outcome of an IIT is out of a pharma company's hands, so it is essential for teams to properly vet each proposal. Otherwise, companies risk putting their products - and the resulting data - into poorly designed studies with inexperienced or unqualified investigators. To avoid problems down the road, successful teams approve IIT proposals that demonstrate scientific merit and align with shifting corporate objectives. Structure plays a key role in ensuring efficient IIT management. IIT structures that facilitate communication across global and local teams align company goals with IIT strategies and approvals.

Performance metrics provide another avenue for teams to boost IIT efficiency. Teams can track the number of submissions they receive, evaluate and approve. Another key metric is the time it takes an IIT team to move a submission through the stages of IIT approval and contract negotiations. Besides providing a productivity lift, performance metrics enable IIT teams to further demonstrate their value to the company.

IITs advance product support while promoting KOL engagement. However, these benefits also come with compliance risks. Proper documentation of investigator services and FMV payments are a primary concern - and a requirement - for teams navigating current compliance codes. A surefire way to reduce many compliance issues is to enable investigators to submit proposals online. Internet portals have built-in systems that document submissions and approvals. They act as a gateway for investigator communication and updates. IIT teams can also turn to third-party vendors for fair market value (FMV) assessments to safeguard against overpaying investigators.

This report delves into each of these challenges - IIT proposal selection, resources, performance metrics and compliance - and serves as a guide to improving IIT management. Its four chapters contain best practices and benchmarks for efficient and rigorous IIT evaluation.

INVESTIGATOR-INITIATED TRIAL MANAGEMENT: KEY RECOMMENDATIONS FOR SUCCESS

Cutting Edge Information analysts synthesized the following five key recommendations from the full breadth and depth of this project's research. These principles are signposts to help improve your IIT team performance. These points emphasize this study's central and most critical concepts.

ADOPT APPROVAL PROCESSES THAT FACILITATE INTERACTION BETWEEN GLOBAL AND LOCAL IIT STRUCTURES

Although companies organize their IIT approval programs in different ways, most structures involve input from teams at both the local and global levels. Involving local and global IIT structures in companies' approval processes helps teams to avoid replicating trials. This practice also ensures that global and local teams outside of IIT support are aware of ongoing studies and are prepared to leverage trial outcomes to support their individual activities. For example, with upcoming IITs in mind, medical communication teams may develop tentative publication timelines. Alternately, marketing teams may plan to use IIT outcomes as an opportunity to refresh existing external-facing materials.

Across many surveyed life science companies, IIT approval processes equate to a two-tiered structure in which global committees furnish the final decision. Surveyed large pharma companies across US and EU markets are especially keen on using twotiered review structures. In these two-tiered structures, local committees may filter incoming IITs first to identify the ones that best fit company needs. Global committees then review the selected proposals and provide final approval. In still other cases, companies may prefer to consolidate global and local feedback within a single, joint committee. An executive at Company B noted that because his team operates under a joint alliance agreement, having a joint committee composed of local and global team members makes IIT approval much easier.

Companies may also have more than one committee operating at local and global levels. The number of committees that companies enlist may be contingent on local markets and the types of IIT proposals. At Company B, separate global committees may review complete protocols and concept design submissions. At Company G, prospective studies undergo more rigorous review than retrospective studies.

Regardless of companies' preferred structures, review committees are often small and contain individuals from a variety of backgrounds. Most frequently, global- and local-level review committees include staff from legal, compliance, medical affairs and clinical teams. To a limited extent, company committees may also house commercialfacing personnel such as marketing and business development team members.

However, not all companies enable each of their committee members to vote. Commercial FTEs rarely have voting privileges, compared to their regulatory, medical affairs and clinical counterparts. Figure E.1 shows that among committees that allow all members to vote, 77% assign either a corporate-level team or a high-level executive to serve as final decision maker. This is the case at only a third of committees in which only selected members have voting privileges.

image1

IMPLEMENT ONLINE PORTALS TO PROVIDE CONSISTENT IIT SUPPORT DURING IIT APPROVAL AND MANAGEMENT

Internet portals facilitate efficient IIT programs by highlighting what types of submissions teams are looking for and by allowing investigators to develop and submit proposals around their busy schedules. Generally, physicians can consult pharma companies' websites to verify which therapeutic areas and study types IIT programs are currently seeking. Having this resource readily available helps physicians to submit their ideas to the companies most likely to both benefit from and accept their proposed trials. This resource also helps companies save time by reducing the number of submissions they receive that fall outside of specified interest areas.

Even before investigator-initiated trials begin, online portals foster external communication between third-party investigators and companies' IIT teams by keeping investigators apprised of submitted concepts' and protocols' approval statuses. For example, by returning to one Top 25 company's site, physicians who have submitted an IIT proposal can view whether the company has opted to accept or reject it - or whether approval is still pending. Being able to track where IITs are on companies' dockets in real time is useful as physicians do not always receive an immediate decision on the IIT proposals they submit. In some cases, this delay is because of the sheer number of proposals that companies' lean IIT structures must process. In others, companies may be interested in an investigator's trial but may lack the resources to move forward with it. In latter situations, companies may delay their approval in hopes that necessary funding or staffing resources will later become available.

Portals are beneficial beyond the proposal evaluation stage as well. Once investigator studies are approved, online portals serve as a point of contact for both investigators and IIT teams. If investigators encounter an unforeseen issue during their trial, they can use the portal to communicate with company team members. Depending on how often companies require investigators to provide updates, this online portal may also replace face-to-face meetings.

Figure E.2 shows that just under half of surveyed teams receive IIT updates quarterly. Another 21% of teams expect investigators to check in once a month. However, it may not be feasible for companies' MSLs to meet with lead investigators every month, or even every quarter. Instead, companies may expect investigators to submit trial updates using online platforms. Figure E.3 shows that all IIT teams surveyed prefer investigators to deliver trial progress updates using a remote resource. Of these teams, 45% favor use of a company-sponsored website.

image2

INCREASE APPROVAL EFFICIENCY BY PRE-SCREENING PROPOSALS

IIT teams strive to evaluate proposals more efficiently to save both time and money. For teams receiving more than 100 proposals a year, evaluations can be especially cumbersome. However, teams do not have to thoroughly assess each proposal they receive. IIT teams can pre-screen proposals to weed out low-quality submissions before they reach the evaluation stage.

In a pre-screening process, personnel eliminate - at the very least - submissions that completely lack scientific merit, are missing information or are not in any way related to the company's corporate research objectives. At Top 50 Company A, a study manager peruses IIT submissions and sends recommendations to the IIT team's medical director. If the medical director likes the proposal then - and only then - will the IIT committee evaluate the submission.

An example of rigorous pre-screening is found at Company 6, which only evaluated 10% of the 100 proposals it received in 2014 (Figure E.4 ). Of the 10 proposals that reached evaluation, the IIT committee approved 8 (80%). The high percentage of approved proposals indicates that the team spent time evaluating only high-quality submissions. By comparison, Top 25 Company 1 received 800 submissions in 2014 and evaluated all 100% of them. In turn, the IIT team approved only 31% of the evaluated proposals.

While these two companies represent only a segment of surveyed teams, they illustrate two ends of the spectrum in terms of evaluation processes. When evaluating submissions, each IIT team will receive different types of submissions and have different criteria, budget concerns or corporate objectives. Hence, the percentage of approved IITs will vary by team. Regardless of the number of approvals, teams can save time and effort by vetting proposals carefully and evaluating only those that are likely to succeed

image3

ACCELERATE AND SIMPLIFY CONTRACT NEGOTIATIONS BY ENTRUSTING THE TASK SOLELY TO LEGAL PERSONNEL

Executives participating in this research report that clinical trial agreement (CTA) negotiations are one of the greatest challenges their IIT teams face. These negotiations can drag on for an average of 70.5 days among companies surveyed (Figure E.5).

image4

Two main reasons for elongated timelines are:

  • Complicated contract review processes
  • Complex negotiations and/or disagreements

CTA negotiation processes vary among surveyed teams, but many have one thing in common: they are complicated. Company 11, for example, channels CTA reviews through legal, budget and clinical groups. Company 24 has an even more involved process: these three groups - as well as compliance, financial, FMV and executive teams - review the contract. This process can create a labyrinth of contract reviews and changes. Instead, Companies 6, 18 and 28 - which have the fastest contract negotiations at only 30 days - entrust legal to handle all CTA negotiations. Though it may seem obvious, legal departments are best suited to review contracts, and their expertise facilitates relatively speedy negotiations.

IIT teams may be wary to leave all contract discussions to legal teams because of the second issue with CTAs: complex negotiations or disagreements over budget or patient safety reporting, for example. CTAs will become more complicated when the IIT involves an interventional study with high-risk products or intellectual property (IP) protection concerns, for example. Teams may fear that legal departments do not have all the resources to discuss these nuances. However, entrusting negotiations to legal does not have to mean that the IIT team loses ownership over the contract.

An executive from Top 25 Company D explained that teams can simplify contract discussion - while maintaining team involvement - by making a clear list of what items are negotiable and non-negotiable. Some teams may not allow the investigator liberties with IP protection, whereas other teams may be more concerned with patient safety reporting. Legal teams armed with a list of the IIT team's requirements and flexible criteria will be poised to conduct efficient and relatively painless CTA negotiations.

AVERAGE SPENDING PER IIT TOPS $100,000

Trial protocol complexity has a major impact on the proposed budget of each IIT, and funding requests can vary greatly from proposal to proposal. Surveyed IIT managers offered examples of funding requests ranging from $10,240 for a urology chart-review study up to $6.5 million for a 50-site, 1,000 patient multiple sclerosis study.

Although each proposed IIT budget should be closely scrutinized to ensure fair market value, average funding per IIT is a very useful budgeting metric. Figure E.6 shows that IIT teams fund an average of $115,000 per study. This number is helpful for top-down budgeting analysis: given a $1 million budget to start the year, an IIT team can comfortably approve about nine studies. It is also useful for building the annual budget from the ground up based on the desired activity level.

image5

Table of Contents

  • 11 Executive Summary
  • 12 Investigator-Initiated Trial Management: Key Recommendations for Success
  • 21 Strengthen IIT Processes by Implementing Structure and Staffing Hierarchies
  • 24 Develop Structure Configurations Based On IIT Objectives
  • 54 Consider Program Profiles When Right-Sizing IIT Staffing
  • 57 Implement Consolidated IIT Management Strategies
  • 84 Trial Outcomes Underscore IIT Value
  • 91 Crafting IIT Approval Strategy and Performance Metrics
  • 95 Tracking IIT Submissions and Timelines to Measure Performance
  • 153 Shaping IIT Approval Strategies to Advance Corporate Goals and Enhance Product Data Portfolios
  • 163 Identifying Trends in Approved IITs
  • 181 Build the Perfect IIT Budget
  • 207 Learn Expected Costs from IIT Spending Case Studies
  • 236 IIT Team Profiles
  • 11 Executive Summary
  • 12 Investigator-Initiated Trial Management: Key Recommendations for Success
  • 13 Figure E.1: IIT Committee Structure: All Teams
  • 15 Figure E.2: Frequency of Receiving IIT Updates from Investigators: All Teams
  • 15 Figure E.3: Teams' Preferences for Receiving IIT Updates: All Teams
  • 17 Figure E.4: Percentage of Evaluated and Approved Proposals in 2014: Global Teams
  • 18 Figure E.5: Number of Days Spent from Contract Negotiation Start to Contract Execution
  • 20 Figure E.6: Average Funding Per Approved IIT in 2014
  • 21 Strengthen IIT Processes by Implementing Structure and Staffing Hierarchies
  • 22 Figure 1.1: A Broad Look at IIT Management
  • 24 Develop Structure Configurations Based on IIT Objectives
  • Figure 1.2: Percentage of Companies with Dedicated IIT Management Groups Over Time
  • Figure 1.3: Corporate IIT Management Structure: All Teams
  • Figure 1.4: Corporate IIT Management Structure: Global IIT Teams
  • Figure 1.5: Corporate IIT Management Structure: US IIT Teams
  • Figure 1.6: Number of IIT Groups, by Company and Region
  • Figure 1.7: Function Involvement in IIT Proposal Collection and Initial Screening: All Teams
  • Figure 1.8: Function Involvement in IIT Proposal Collection and Initial Screening: Global Teams
  • Figure 1.9: Function Involvement in IIT Proposal Collection and Initial Screening: US Teams
  • Figure 1.10: Function Involvement in IIT Proposal Evaluation and Approval: All Teams
  • Figure 1.11: Function Involvement in IIT Proposal Evaluation and Approval: Global Teams
  • Figure 1.12: Function Involvement in IIT Proposal Evaluation and Approval: US Teams
  • Figure 1.13: Function Involvement in IIT Oversight: All Teams
  • Figure 1.14: Function Involvement in IIT Oversight: Global Teams
  • Figure 1.15: Function Involvement in IIT Oversight: US Teams
  • Figure 1.16: Function Involvement in IIT Conclusion and Use of Data Findings: All Teams
  • Figure 1.17: Function Involvement in IIT Conclusion and Use of Data Findings: Global Teams
  • Figure 1.18: Function Involvement in IIT Conclusion and Use of Data Findings: US Teams
  • Figure 1.19: Percentage of All Teams with Written SOPs for Specific IIT Processes
  • Figure 1.20: Percentage of Global Teams with Written SOPs for Specific IIT Processes
  • Figure 1.21: Percentage of US Teams with Written SOPs for Specific IIT Processes
  • Figure 1.22: Ratings of Challenges Associated with IIT Structure and Management

Consider Program Profiles When Right-Sizing IIT Staffing Implement Consolidated IIT Management Strategies

  • Figure 1.23: Processes for Increasing IIT Review Efficiency for Global Teams: Company B
  • Figure 1.24: IIT Committee Structure: All Teams
  • Figure 1.25: IIT Committee Structure: Global Teams
  • Figure 1.26: IIT Committee Structure: US Teams
  • Figure 1.27: Total Number of IIT Committee Members, by Function: Global Teams
  • Figure 1.28: IIT Committee Voting Members, by Function: Global Teams
  • Figure 1.29: Total Number of IIT Committee Members, by Function: US Teams
  • Figure 1.30: IIT Committee Voting Members, by Function: US Teams
  • Figure 1.31: IIT Committee Voting Members, by Function: ex-US Teams
  • Figure 1.32: Functions with Voting Privileges on IIT Committees for Teams That Segment Voting Responsibilities
  • Figure 1.33: Milestone Payments Used for IITs: All Teams
  • Figure 1.34: Milestone Payments Used for IITs: Global Teams
  • Figure 1.35: Milestone Payments Used for IITs: US Teams
  • Figure 1.36: Teams' Preferences for Receiving IIT Updates: All Teams
  • Figure 1.37: Teams' Preferences for Receiving IIT Updates: Global Teams
  • Figure 1.38: Teams' Preferences for Receiving IIT Updates: US Teams
  • Figure 1.39: Frequency of Receiving IIT Updates from Investigators: All Teams
  • Figure 1.40: Frequency of Receiving IIT Updates from Investigators: Global Teams
  • Figure 1.41: Frequency of Receiving IIT Updates from Investigators: US Teams
  • Figure 1.42: Frequency of IIT Meetings Compared to Update Method
  • Figure 1.43: MSLs' Role in IIT Management: All Teams
  • Figure 1.44: MSLs' Role in IIT Management: Global Teams
  • Figure 1.45: MSLs' Role in IIT Management: US Teams

Trial Outcomes Underscore IIT Value

  • Figure 1.46: Percentage of IITs Published, by Company and Region
  • Figure 1.47: Tactics to Ensure Publication Strategies Are Met

Crafting IIT Approval Strategy and Performance Metrics

  • Figure 2.1: Three Steps for Increasing IIT Efficiency
  • Figure 2.2: Ratings of Challenges Associated with IIT Approvals

Tracking IIT Submissions and Timelines to Measure Performance

  • Figure 2.3: Average Number of Proposals Received in 2014, by Region
  • Figure 2.4: Average Number of Proposals Evaluated in 2014, by Region
  • Figure 2.5: Average Number of Proposals Approved in 2014, by Region
  • Figure 2.6: Average Percentage of Submitted Proposals that Were Evaluated in 2014, by Region
  • Figure 2.7: Average Percentage of Evaluated Proposals that Were Approved in 2014, by Region
  • Figure 2.8: Number of Proposals Submitted, Evaluated and Approved in 2013: Global Teams
  • Figure 2.9: Number of Proposals Submitted, Evaluated and Approved in 2014: Global Teams
  • Figure 2.10: Number of Proposals Submitted, Evaluated and Approved in 2015: Global Teams
  • Figure 2.11: Percentage of Proposals Received that Were Evaluated, by Year: Global Teams
  • Figure 2.12: Percentage of Proposals Evaluated that Were Approved, by Year: Global Teams
  • Figure 2.13: Number of Proposals Submitted, Evaluated and Approved in 2013: Top 25 and Top 50 US Teams
  • Figure 2.14: Number of Proposals Submitted, Evaluated and Approved in 2014: Top 25 and Top 50 US Teams
  • Figure 2.15: Number of Proposals Submitted, Evaluated and Approved in 2015: Top 25 and Top 50 US Teams
  • Figure 2.16: Percentage of Proposals Received that Were Evaluated, by Year: Top 25 and Top 50 US Teams
  • Figure 2.17: Percentage of Proposals Evaluated that Were Approved, by Year: Top 25 and Top 50 US Teams
  • Figure 2.18: Number of Proposals Submitted, Evaluated and Approved in 2013: Small and Device Company US Teams
  • Figure 2.19: Number of Proposals Submitted, Evaluated and Approved in 2014: Small and Device Company US Teams
  • Figure 2.20: Number of Proposals Submitted, Evaluated and Approved in 2015: Small and Device Company US Teams
  • Figure 2.21: Percentage of Proposals Received that Were Evaluated, by Year: Small and Device Company US Teams
  • Figure 2.22: Percentage of Proposals Evaluated that Were Approved, by Year: Small and Device Company US Teams
  • Figure 2.23: Number of Proposals Submitted, Evaluated and Approved in 2013: ex-US Teams
  • Figure 2.24: Number of Proposals Submitted, Evaluated and Approved in 2014: ex-US Teams
  • Figure 2.25: Number of Proposals Submitted, Evaluated and Approved in 2015: ex-US Teams
  • Figure 2.26: Percentage of Proposals Received that Were Evaluated, by Year: ex-US Teams
  • Figure 2.27: Percentage of Proposals Evaluated that Were Approved, by Year: ex-US Teams
  • Figure 2.28: Average Percentage of IIT Proposals Received through Different Channels, by Region
  • Figure 2.29: Percentage of IIT Proposals Received through Different Channels: Global Teams
  • Figure 2.30: Percentage of IIT Proposals Received through Different Channels: Top 25 and Top 50 US Teams
  • Figure 2.31: Percentage of IIT Proposals Received through Different Channels: Small Company US Teams
  • Figure 2.32: Percentage of IIT Proposals Received through Different Channels: ex-US Teams
  • Figure 2.33: Average Percentage of IIT Submissions First Received as Concept and Protocol Proposals
  • Figure 2.34: Percentage of IIT Submissions First Received as Concept and Protocol Proposals: Global Teams
  • Figure 2.35: Percentage of IIT Submissions First Received as Concept and Protocol Proposals: US Teams
  • Figure 2.36: Percentage of IIT Submissions First Received as Concept and Protocol Proposals: ex-US Teams
  • Figure 2.37: Frequency of IIT Proposal Evaluation Meetings, by Region
  • Figure 2.38: Frequency of Meetings Compared to Number of Evaluated IIT Proposals
  • Figure 2.39: Number of Days Spent from IIT Concept Submission to Concept Review, by Company and Region
  • Figure 2.40: Number of Days Spent from IIT Concept Review to Concept Decision, by Company and Region
  • Figure 2.41: Number of Days Spent from IIT Concept Decision to Investigator Notification, by Company and Region
  • Figure 2.42: Number of Days Spent from Investigator Notification to Protocol Submission, by Company and Region
  • Figure 2.43: Number of Days Spent from IIT Protocol Submission to Protocol Review: Global Teams
  • Figure 2.44: Number of Days Spent from IIT Protocol Submission to Protocol Review: Top 25 and Top 50 US Teams
  • Figure 2.45: Number of Days Spent from IIT Protocol Submission to Protocol Review: Small and Device Company US Teams
  • Figure 2.46: Number of Days Spent from IIT Protocol Submission to Protocol Review: ex-US Teams
  • Figure 2.47: Number of Days Spent from IIT Protocol Review to Protocol Decision: Global Teams
  • Figure 2.48: Number of Days Spent from IIT Protocol Review to Protocol Decision: Top 25 and Top 50 US Teams
  • Figure 2.49: Number of Days Spent from IIT Protocol Review to Protocol Decision: Small and Device Company US Teams
  • Figure 2.50: Number of Days Spent from IIT Protocol Review to Protocol Decision: ex-US Teams
  • Figure 2.51: Number of Days Spent from IIT Concept Decision to Protocol Decision, by Company and Region
  • Figure 2.52: Number of Days Spent from IIT Protocol Decision to Contract Negotiation Start: Global Teams
  • Figure 2.53: Number of Days Spent from IIT Protocol Decision to Contract Negotiation Start: Top 25 and Top 50 US Teams
  • Figure 2.54: Number of Days Spent from IIT Protocol Decision to Contract Negotiation Start: Small and Device Company US Teams
  • Figure 2.55: Number of Days Spent from IIT Protocol Decision to Contract Negotiation Start: ex-US Teams
  • Figure 2.56: Number of Days Spent from IIT Concept Submission to Contract Negotiation Start, by Company and Region
  • Figure 2.57: Number of Days Spent from IIT Contract Negotiation Start to Contract Execution, by Company and Region
  • Figure 2.58: Number of Days Spent from IIT Contract Execution to First Patient in Study, by Company and Region
  • Figure 2.59: Timeline for Approving and Beginning an IIT: Company 1 (Top 25 Global Team)
  • Figure 2.60: Timeline for Approving and Beginning an IIT: Company 4 (Top 25 Global Team)
  • Figure 2.61: Timeline for Approving and Beginning an IIT: Company 6 (Top 50 Global Team)
  • Figure 2.62: Timeline for Approving and Beginning an IIT: Company 7 (Top 50 Global Team)
  • Figure 2.63: Timeline for Approving and Beginning an IIT: Company 9 (Top 25 US Team)
  • Figure 2.64: Timeline for Approving and Beginning an IIT: Company 10 (Top 25 US Team)
  • Figure 2.65: Timeline for Approving and Beginning an IIT: Company 14 (Top 50 US Team)
  • Figure 2.66: Timeline for Approving and Beginning an IIT: Company 18 (Top 50 US Team)
  • Figure 2.67: Timeline for Approving and Beginning an IIT: Company 25 (Top 25 ex-US Team)
  • Figure 2.68: Timeline for Approving and Beginning an IIT: Company 28 (Device ex-US Team)
  • Figure 2.69: Comparing IIT Timelines with Similar Cumulative Days Spent to Contract Negotiation Start

Shaping IIT Approval Strategies to Advance Corporate Goals and Enhance Product Data Portfolios

  • Figure 2.70: Ratings of Important IIT Outcomes
  • Figure 2.71: Criteria Ranked Most Important When Evaluating an IIT Proposal: 1st Through 4th Important Criteria
  • Figure 2.72: Criteria Ranked Most Important When Evaluating an IIT Proposal: 5th Through 8th Important Criteria
  • Figure 2.73: Reasons for Automatically Rejecting an IIT Proposal Identifying Trends in Approved IITs
  • Figure 2.74: Average Percentage of IITs with Different Target Patient Enrollment, by Region
  • Figure 2.75: Percentage of IITs with Different Target Patient Enrollment: Global Teams
  • Figure 2.76: Number of Approved IITs in 2014 by Target Patient Enrollment: Global Teams
  • Figure 2.77: Percentage of IITs with Different Target Patient Enrollment: US Teams
  • Figure 2.78: Number of Approved IITs in 2014 by Target Patient Enrollment: US Teams
  • Figure 2.79: Percentage of IITs with Different Target Patient Enrollment: ex-US Teams
  • Figure 2.80: Number of Approved IITs in 2014 by Target Patient Enrollment: ex-US Teams
  • Figure 2.81: Average Percentage of IITs with Different Numbers of Sites, by Region
  • Figure 2.82: Percentage of IITs with Different Numbers of Sites: Global Teams
  • Figure 2.83: Number of Approved IITs in 2014 by Company and Number of Sites: Global Teams
  • Figure 2.84: Percentage of IITs with Different Numbers of Sites: US Teams
  • Figure 2.85: Number of Approved IITs in 2014 by Company and Number of Sites: US Teams
  • Figure 2.86: Percentage of IITs with Different Numbers of Sites: ex-US Teams
  • Figure 2.87: Number of Approved IITs in 2014 by Company and Number of Sites: ex-US Teams
  • Figure 2.88: Average Percentage of Approved IITs That Are Retrospective Studies, by Region
  • Figure 2.89: Average Percentage of Approved IITs That Are Interventional Studies, by Region
  • Figure 2.90: Average Percentage of Approved IITs That Gather Data About a Secondary Indication, by Region
  • Figure 2.91: Average Percentage of Approved IITs That Gather Data about a New Patient Population/Subgroup, by Region
  • Figure 2.92: Average Percentage of Approved IITs That Gather Data About New Dosing, by Region
  • Figure 2.93: Average Percentage of Approved IITs That Gather Comparative Effectiveness Data, by Region
  • Figure 2.94: Average Percentage of Approved IITs That Gather Patient-Reported Outcomes, by Region

Build the Perfect IIT Budget

  • Figure 3.1: Sample IIT Budget
  • Figure 3.2: Ratings of Challenges Associated with IIT Budgets
  • Figure 3.3: Percentage of IIT Budget Dedicated at Beginning of Year, by Region
  • Figure 3.4: Percentage of IIT Budget Dedicated at Beginning of Year: Global Teams
  • Figure 3.5: Percentage of IIT Budget Dedicated at Beginning of Year: US Teams
  • Figure 3.6: Percentage of IIT Budget Dedicated at Beginning of Year: ex-US Teams
  • Figure 3.7: Average Percentage of IIT Spending from Different Functions, by Region
  • Figure 3.8: Percentage of IIT Spending from Different Functions: Global Teams
  • Figure 3.9: Percentage of IIT Spending from Different Functions: Top 25 and Top 50 US Teams
  • Figure 3.10: Percentage of IIT Spending from Different Functions: Small and Device Company US Teams
  • Figure 3.11: Percentage of IIT Spending from Different Functions: ex-US Teams
  • Figure 3.12: Percentage of Budget Spent on IIT Funding and Internal Management, by Company and Region
  • Figure 3.13: Internal IIT Management Costs, by Year: Global Teams
  • Figure 3.14: Internal IIT Management Costs, by Year: US Teams
  • Figure 3.15: Internal IIT Management Costs, by Year: ex-US Teams
  • Figure 3.16: Average Funding per Approved IIT in 2014
  • Figure 3.17: IIT Funding Compared to the Number of Approvals for 2014: Global Teams
  • Figure 3.18: IIT Funding Compared to the Number of Approvals for 2014: US Teams
  • Figure 3.19: IIT Funding Compared to the Number of Approvals for 2014: ex-US Teams
  • Figure 3.20: IIT Budget Changes from 2015 to 2016
  • Figure 3.21: IIT Funding for Investigators, by Year: Global Teams
  • Figure 3.22: IIT Funding for Investigators, by Year: Top 25 and Top 50 US Teams
  • Figure 3.23: IIT Funding for Investigators, by Year: Small Company US Teams
  • Figure 3.24: IIT Funding for Investigators, by Year: ex-US Teams
  • Figure 3.25: IIT Teams' Responses to Unacceptable Proposed Budgets
  • Figure 3.26: Number of Allowed IIT Budget Revisions, by Region

Learn Expected Costs from IIT Spending Case Studies

  • Figure 3.27: Total Company Funding for an IIT: Trials with More Than 100 Patients Enrolled
  • Figure 3.28: Total Company Funding for an IIT: Trials with Fewer Than 100 Patients Enrolled
  • Figure 3.29: Total Company Funding for an IIT: Oncology Trials
  • Figure 3.30: IIT Funding: Cost of IRB (Initial Review)
  • Figure 3.31: IIT Funding: Cost of IRB (Continued Review)
  • Figure 3.32: IIT Funding: Cost of IRB (Amendments)
  • Figure 3.33: IIT Funding: Cost of IND and Other Regulatory Requirements
  • Figure 3.34: IIT Funding: Cost of Publication
  • Figure 3.35: IIT Funding: Cost of Study and Laboratory Supplies
  • Figure 3.36: IIT Funding: Cost of Diagnostic Fees and Services
  • Figure 3.37: IIT Funding: Cost of Pharmacy Start-Up Fees
  • Figure 3.38: IIT Funding: Cost of Data Management
  • Figure 3.39: IIT Funding: Cost of Document Storage Fees
  • Figure 3.40: IIT Funding: Cost of Patient Recruitment
  • Figure 3.41: IIT Funding: Cost of Staffing Overhead
  • Figure 3.42: IIT Funding: Cost of Initiation Fees
  • Figure 3.43: IIT Funding: Cost of Office Supplies
  • Figure 3.44: Budget Case Study: Company 15
  • Figure 3.45: Budget Case Study: Company 10
  • Figure 3.46: Budget Case Study: Company 9
  • Figure 3.47: Budget Case Study: Company 4
  • Figure 3.48: Budget Case Study: Company 25
  • Figure 3.49: Budget Case Study: Company 14
  • Figure 3.50: Budget Case Study: Company 17
  • Figure 3.51: Budget Case Study: Company 22
  • Figure 3.52: Budget Case Study: Company 16
  • Figure 3.53: Budget Case Study: Company 6
  • Figure 3.54: Budget Case Study: Company 28
  • Figure 3.55: Budget Case Study: Company 26

IIT Team Profiles

  • Figure 4.1: Company 1: Structure
  • Figure 4.2: Company 1: Budgets and Proposals
  • Figure 4.3: Company 4: Structure
  • Figure 4.4: Company 4: Budgets and Proposals
  • Figure 4.5: Company 6: Structure
  • Figure 4.6: Company 6: Budgets and Proposals
  • Figure 4.7: Company 10: Structure
  • Figure 4.8: Company 10: Budgets and Proposals
  • Figure 4.9: Company 14: Structure
  • Figure 4.10: Company 14: Budgets and Proposals
  • Figure 4.11: Company 15: Structure
  • Figure 4.12: Company 15: Budgets and Proposals
  • Figure 4.13: Company 25: Structure
  • Figure 4.14: Company 25: Budgets and Proposals
  • Figure 4.15: Company 28: Structure
  • Figure 4.16: Company 28: Budgets and Proposals
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