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市場調查報告書

市售後臨床試驗的優點:為了展示實際成果的第四階段實驗的設計

Postmarketing Study Excellence: Design Phase 4 Trials to Demonstrate Real-World Outcomes

出版商 Cutting Edge Information 商品編碼 214209
出版日期 內容資訊 英文 275 Pages
商品交期: 最快1-2個工作天內
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市售後臨床試驗的優點:為了展示實際成果的第四階段實驗的設計 Postmarketing Study Excellence: Design Phase 4 Trials to Demonstrate Real-World Outcomes
出版日期: 2016年07月21日 內容資訊: 英文 275 Pages
簡介

本報告提供醫藥品經營者的第四階段實驗 (市售後臨床試驗)的實施趨勢調查,組織結構、人力資源配置比較與最佳業務實踐,介入研究、觀察研究、回顧性研究的比較與最佳業務實踐,外包趨勢,主要的第四階段實驗 (市售後臨床試驗)的詳細介紹,成功的建議等彙整資料。

摘要整理

上市後監測:成功的主要建議

  • 關於本報告

由於強力的組織結構及人力資源,提高第四階段的有效監視能力的

  • 市售後研究部門的組織化:全球、地區層級的隊伍的專門群組的階層
  • 市售後策略的建立流程

上市後監測的資源和人力資源

  • 預算的最佳化支援第四階段實驗
  • 有效的市售後團隊的人員結構
  • 為了最大化能力的市售後活動的外包

市售後臨床試驗趨勢

  • 市售後臨床試驗的目的
  • 規劃及實行開始的生命週期階段
  • 每個產品的實驗數檢討
  • 實施實驗的類型
  • 文獻

為了得到有益的臨床表現而多樣化介入研究的設計

  • 介入研究趨勢
  • 介入研究的資源
  • 介入研究的時間軸
  • 介入研究簡介
  • 文獻

觀察研究的實資料分析

  • 觀察研究趨勢
  • 觀察研究的資源
  • 觀察研究的時間軸
  • 觀察研究簡介
  • 文獻

早期規劃最大化回顧性研究的成果

  • 回顧性研究的資源:有效利用公司內部能力以節約相關成本
  • 研究的實施:配合措施的時間軸與課題
  • 回顧性研究簡介
  • 附錄

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目錄
Product Code: PH220

Postmarketing studies are undergoing a revolution. No longer seen as optional, latestage studies are conducted to investigate product effectiveness, health economic outcomes, product utilization and other key data not readily collected in Phase 3 trials. Phase 4 studies are necessary for some products to maintain market authorization and are crucial for earning product reimbursement and market share.

Late-stage study teams are innovating trial designs beyond traditional randomized controlled trials (RCTs) to examine specific endpoints and to collect real-world data. These study designs include newer interventional studies such as pragmatic RCTs as well as advances in observational and retrospective studies. This report analyzes the percentage of postmarketing studies that adhere to different interventional and observational study designs and compares benchmarks for these designs.

As postmarketing studies teams innovate, team structure could play a large role in whether teams receive the support they need to succeed. Similarly, decisions regarding budgets, staffing and outsourcing are critical to ensuring that study teams have the necessary resources. Chapters 1 and 2 of this report offer structure best practices and resource benchmarks.

While trial success is often contingent on the results of the study, late-stage study teams can also demonstrate value by maintaining efficient study timelines, outlined throughout the report. Furthermore, cutting edge teams want to keep up with postmarketing study trends, such as the number of studies conducted and the average number of studies conducted per product.

Finally, the last three chapters of this report analyze patient enrollment, costs, outsourcing, study objectives and timeline benchmarks for specific interventional, observational and retrospective studies for which survey respondents provided data. These chapters help teams to compare resources and study plans across different trial designs. Each of these chapters ends with more detailed profiles of select studies to help postmarketing study leaders understand the study's story.

POSTMARKETING STUDIES: 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 postmarketing studies team performance. These points emphasize this study's central and most critical concepts.

LEVERAGE MEDICAL AFFAIRS' EXPERTISE TO GUIDE POSTMARKETING STUDY DEVELOPMENT AND EXECUTION

Dedicated teams conducting Phase 4 research often turn to medical affairs to provide additional guidance for their activities. Indeed, of the surveyed life science teams with dedicated postmarketing groups, 78% align them under medical affairs. The nextclosest function - clinical development - oversees dedicated postmarketing groups' activities at only 17% of surveyed companies.

Medical affairs functions play a key role in late-stage research, even among companies without dedicated postmarketing groups. Among all companies surveyed, medical affairs functions overwhelmingly handle the planning aspect of postmarketing research. Broadly, medical affairs functions are involved in strategic study planning at 93% of surveyed life science teams (Figure E.1). Taking a look at how this trend stacks up globally and regionally shows that:

  • All surveyed global teams involve their medical affairs functions in strategic study planning.
  • Medical affairs functions at 86% of surveyed US-level teams contribute to the postmarketing study planning process.
  • Nearly all surveyed country-level teams (92%) outside the US also expect medical affairs functions to assist with postmarketing study development.

Figure E.1:
Functions Involved in Different Postmarketing Study Activities

Table of Contents

Executive Summary

Postmarketing Studies: Key Recommendations for Success

  • About This Report

Promote Efficient Phase 4 Oversight Capabilities with Robust Postmarketing Structures and Staffing

  • Organizing Postmarketing Structures: The Hierarchy of Dedicated Groups Across Global and Regional Team Levels
  • The Process Behind Building a Postmarketing Strategy

Resourcing and Staffing Postmarketing Studies

  • Optimizing Budgets to Support Phase 4 Research
  • Staffing Effective Postmarketing Teams
  • Outsourcing Postmarketing Activities to Maximize Capabilities

Postmarketing Study Trends

  • Postmarketing Study Objectives
  • Lifecycle Stage When Study Planning and Execution Begin
  • Consider Number of Studies per Product When Planning Number of Studies Conducted
  • Types of Conducted Studies Consistent Across Years and Regions
  • References

Diversify Interventional Study Designs to Yield Informative Clinical Findings

  • Interventional Study Trends
  • Interventional Study Resources
  • Interventional Study Timelines
  • Interventional Study Profiles
  • References

Explore Real-World Data with Observational Studies

  • Observational Study Trends
  • Observational Study Resources
  • Observational Study Timelines
  • Observational Study Profiles
  • References

Maximize Retrospective Study Outcomes Through Early Planning

  • Retrospective Study Resources: Leverage Internal Expertise to Conserve Associated Costs
  • Study Execution: Activity Timelines and Challenges
  • Retrospective Study Profiles
  • Appendix

Executive Summary

Postmarketing Studies: Key Recommendations for Success

  • Figure E.1: Functions Involved in Different Postmarketing Study Activities
  • Figure E.2: Average Number of Postmarketing Studies per Product, by Company Size and Year
  • Figure E.3: Percentage of Companies Outsourcing Specific Postmarketing Trial Activities
  • Figure E.4: Number of Days to Complete Specific Postmarketing Trial Activities
  • Figure E.5: Percentage of Companies Providing the Product to Patients for Observational Studies
  • Figure E.6: Primary Objectives for Postmarketing Studies: 2015, by Team Region

Promote Efficient Phase 4 Oversight Capabilities with Robust Postmarketing Structures and Staffing

  • Figure 1.1: Function Under Which Dedicated Postmarketing Studies Teams Sit

Organizing Postmarketing Structures: The Hierarchy of Dedicated Groups Across Global and Regional Team Levels

  • Figure 1.2: Postmarketing Studies Groups' Scope of Responsibility at Surveyed Companies, by Team Region
  • Figure 1.3: Postmarketing Studies Groups' Scope of Responsibility at Surveyed Companies, by Company Size
  • Figure 1.4: Functions Involved in Certain Postmarketing Study Activities
  • Figure 1.5: Percentage of Teams with Certain Functions Involved in Study Strategic Planning, by Team Region
  • Figure 1.6: Percentage of Teams with Certain Functions Involved in Study Execution, by Team Region

The Process Behind Building a Postmarketing Strategy

Resourcing and Staffing Postmarketing Studies

Optimizing Budgets to Support Phase 4 Research

  • Figure 2.1: Postmarketing Study Costs, by Year: Global Teams
  • Figure 2.2: Postmarketing Study Costs, by Year: Small Company 14's US Team
  • Figure 2.3: Postmarketing Study Costs, by Year: Country-Level Teams
  • Figure 2.4: Postmarketing Study Costs, by Year: Device Company 23's Country-Level Team
  • Figure 2.5: Percentage of Study Costs Allocated to Different Types of Studies, by Year: Global Teams
  • Figure 2.6: Percentage of Study Costs Allocated to Different Types of Studies, by Year: Country-Level Teams
  • Figure 2.7: Total Interventional Study Costs, by Year
  • Figure 2.8: Total Observational Study Costs, by Year
  • Figure 2.9: Total Retrospective Study Costs, by Year
  • Figure 2.10: Postmarketing Study Team Salaries and Overhead Costs: Top 10 Company 1's Global Team
  • Figure 2.11: Postmarketing Study Team Salaries and Overhead Costs: Country-Level Teams

Staffing Effective Postmarketing Teams

  • Figure 2.12: Postmarketing Studies Team Size, by Year: Global Teams
  • Figure 2.13: Percentage Change in Staffing: Global Teams
  • Figure 2.14: Postmarketing Studies Team Size, by Year: US Teams
  • Figure 2.15: Postmarketing Studies Team Size, by Year: Country-Level Teams
  • Figure 2.16: Percentage Change in Postmarketing Team Staffing: Country-Level Teams

Outsourcing Postmarketing Activities to Maximize Capabilities

  • Figure 2.17: Percentage of Actual Study Costs Outsourced, by Study Type
  • Figure 2.18: Comparing Timelines and Outsourcing Practices: Protocol Development
  • Figure 2.19: Comparing Timelines and Outsourcing Practices: Investigator and Site Recruitment
  • Figure 2.20: Comparing Timelines and Outsourcing Practices: Investigator and Site Contract Negotiations
  • Figure 2.21: Comparing Timelines and Outsourcing Practices: Investigator and Site Training

Postmarketing Study Trends

  • Figure 3.1: Use of Digital Technology in Postmarketing Studies, by Study Type
  • Figure 3.2: Percentage of US Studies Requiring an IND, by Study Type
  • Figure 3.3: Range and Average Number of Days Spent from Study Planning to Submission of Manuscript for Publication
  • Figure 3.4: Range and Average Number of Days Spent from Study Planning to First Patient In Study

Postmarketing Study Objectives

  • Figure 3.5: Average Primary Objectives for Postmarketing Studies, by Year: All Teams
  • Figure 3.6: Average Primary Objectives for Postmarketing Studies, by Year: Global Teams
  • Figure 3.7: Average Primary Objectives for Postmarketing Studies, by Year: US Teams
  • Figure 3.8: Average Primary Objectives for Postmarketing Studies, by Year: Country-Level Teams
  • Figure 3.9: Primary Objectives for Postmarketing Studies, by Study Type
  • Figure 3.10: Primary Objectives for Postmarketing Studies, by Product Type

Lifecycle Stage When Study Planning and Execution Begin

  • Figure 3.11: Stage When Postmarketing Study Planning and Execution Began: All Studies
  • Figure 3.12: Stage When Postmarketing Study Execution Began, by Product Type

Consider Number of Studies per Product When Planning Number of Studies Conducted

  • Figure 3.13: Total and Average Number of Studies per Product for 2014, by Company: Global Teams
  • Figure 3.14: Total and Average Number of Studies per Product for 2015, by Company: Global Teams
  • Figure 3.15: Total and Average Number of Studies per Product for 2016, by Company: Global Teams
  • Figure 3.16: Total and Average Number of Studies per Product for 2014, by Company: US Teams
  • Figure 3.17: Total and Average Number of Studies per Product for 2015, by Company: US Teams
  • Figure 3.18: Total and Average Number of Studies per Product for 2016, by Company: US Teams
  • Figure 3.19: Total and Average Number of Studies per Product for 2014, by Company: Country-Level Teams
  • Figure 3.20: Total and Average Number of Studies per Product for 2015, by Company: Country-Level Teams
  • Figure 3.21: Total and Average Number of Studies per Product for 2016, by Company: Country-Level Teams

Types of Conducted Studies Consistent Across Years and Regions

  • Figure 3.22: Average Percentage of Postmarketing Studies That Are Certain Study Types, by Year: All Teams
  • Figure 3.23: Average Percentage of Postmarketing Studies That Are Certain Study Types, by Team Region: 2015
  • Figure 3.24: Number of Postmarketing Studies Conducted in 2014, by Study Type: Global Teams
  • Figure 3.25: Number of Postmarketing Studies Conducted in 2015, by Study Type: Global Teams
  • Figure 3.26: Number of Postmarketing Studies Conducted in 2016, by Study Type: Global Teams
  • Figure 3.27: Number of Postmarketing Studies Conducted in 2014, by Study Type: US Teams
  • Figure 3.28: Number of Postmarketing Studies Conducted in 2015, by Study Type: US Teams
  • Figure 3.29: Number of Postmarketing Studies Conducted in 2016, by Study Type: US Teams
  • Figure 3.30: Number of Postmarketing Studies Conducted in 2014, by Study Type: Country-Level Teams
  • Figure 3.31: Number of Postmarketing Studies Conducted in 2015, by Study Type: Country-Level Teams
  • Figure 3.32: Number of Postmarketing Studies Conducted in 2016, by Study Type: Country-Level Teams

References

Diversify Interventional Study Designs to Yield Informative Clinical Findings

  • Figure 4.1: Percentage of Teams Conducting Interventional Studies, by Year
  • Figure 4.2: Percentage of Interventional Studies That Included Retrospective Data

Interventional Study Trends

  • Figure 4.3: Average Percentage of Interventional Studies Following Particular Trial Designs
  • Figure 4.4: Objectives for Traditional RCTs
  • Figure 4.5: Percentage of Target Patient Enrollment Achieved: Interventional Studies
  • Figure 4.6: Number of Patients per Site: Interventional Studies

Interventional Study Resources

  • Figure 4.7: Difference in Planned and Actual Study Costs: Interventional Studies
  • Figure 4.8: Percentage of Actual Study Costs Outsourced: Interventional Studies
  • Figure 4.9: Percentage of Interventional Studies That Outsourced Certain Items
  • Figure 4.10: Number of Days Spent Recruiting and Selecting Vendors: Interventional Studies
  • Figure 4.11: Number of Days Spent Negotiating Vendor Contracts: Interventional Studies
  • Figure 4.12: Total Staffing for Interventional Studies

Interventional Study Timelines

  • Figure 4.13: Stage When Study Planning and Execution Began: Interventional Studies
  • Figure 4.14: Number of Days Spent from Study Planning to First Patient In: Interventional Studies
  • Figure 4.15: Number of Days Spent from First Patient In to Last Patient In: Interventional Studies
  • Figure 4.16: Number of Days Spent from Last Patient In to Data Lock: Interventional Studies
  • Figure 4.17: Number of Days Spent from Data Lock to Submission of Manuscript for Publication: Interventional Studies
  • Figure 4.18: Number of Days Spent Training Investigators and Sites: Interventional Studies

Interventional Study Profiles

  • Figure 4.19: Interventional Study A: Background
  • Figure 4.20: Interventional Study A: Costs and Outsourcing
  • Figure 4.21: Interventional Study A: Staffing
  • Figure 4.22: Interventional Study A: Study Timeline
  • Figure 4.23: Interventional Study H: Background
  • Figure 4.24: Interventional Study H: Costs and Outsourcing
  • Figure 4.25: Interventional Study H: Staffing
  • Figure 4.26: Interventional Study H: Study Timeline
  • Figure 4.27: Interventional Study I: Background
  • Figure 4.28: Interventional Study I: Costs and Outsourcing
  • Figure 4.29: Interventional Study I: Staffing
  • Figure 4.30: Interventional Study I: Study Timeline
  • Figure 4.31: Interventional Study J: Background
  • Figure 4.32: Interventional Study J: Costs and Outsourcing
  • Figure 4.33: Interventional Study J: Staffing
  • Figure 4.34: Interventional Study J: Study Timeline
  • Figure 4.35: Interventional Study M: Background
  • Figure 4.36: Interventional Study M: Costs and Outsourcing
  • Figure 4.37: Interventional Study M: Staffing
  • Figure 4.38: Interventional Study M: Study Timeline

References

Explore Real-World Data with Observational Studies

  • Figure 5.1: Percentage of Teams Conducting Observational Studies, by Year
  • Figure 5.2: Percentage of Observational Studies That Included Retrospective Data

Observational Study Trends

  • Figure 5.3: Average Percentage of Observational Studies Following Particular Trial Designs
  • Figure 5.4: Percentage of Observational Studies with Certain Objectives, by Study Design
  • Figure 5.5: Percentage of Target Patient Enrollment Achieved: Observational Studies
  • Figure 5.6: Number of Patients per Site: Observational Studies
  • Figure 5.7: Percentage of Companies Providing the Product to Patients for Observational Studies

Observational Study Resources

  • Figure 5.8: Difference in Planned and Actual Study Costs: Observational Studies
  • Figure 5.9: Percentage of Actual Study Costs Outsourced: Observational Studies
  • Figure 5.10: Percentage of Observational Studies That Outsourced Certain Items
  • Figure 5.11: Number of Days Spent Recruiting and Selecting Vendors: Observational Studies
  • Figure 5.12: Number of Days Spent Negotiating Vendor Contracts: Observational Studies
  • Figure 5.13: Total Staffing for Observational Studies
  • Figure 5.14: Stage When Study Planning and Execution Began: Observational Studies

Observational Study Timelines

  • Figure 5.15: Number of Days Spent from Study Planning to First Patient In: Observational Studies
  • Figure 5.16: Number of Days Spent from First Patient In to Last Patient In: Observational Studies
  • Figure 5.17: Number of Days Spent from Last Patient In to Data Lock: Observational Studies
  • Figure 5.18: Number of Days Spent from Data Lock to Submission of Manuscript for Publication: Observational Studies
  • Figure 5.19: Number of Days Spent Training Investigators and Sites: Observational Studies

Observational Study Profiles

  • Figure 5.20: Observational Study B: Background
  • Figure 5.21: Observational Study B: Costs and Outsourcing
  • Figure 5.22: Observational Study B: Staffing
  • Figure 5.23: Observational Study B: Study Timeline
  • Figure 5.24: Observational Study R: Background
  • Figure 5.25: Observational Study R: Costs and Outsourcing
  • Figure 5.26: Observational Study R: Staffing
  • Figure 5.27: Observational Study R: Study Timeline
  • Figure 5.28: Observational Study V: Background
  • Figure 5.29: Observational Study V: Costs and Outsourcing
  • Figure 5.30: Observational Study V: Staffing
  • Figure 5.31: Observational Study V: Study Timeline
  • Figure 5.32: Observational Study AA: Background
  • Figure 5.33: Observational Study AA: Costs and Outsourcing
  • Figure 5.34: Observational Study AA: Staffing
  • Figure 5.35: Observational Study AA: Study Timeline

References

Maximize Retrospective Study Outcomes Through Early Planning

  • Figure 6.1: Percentage of Teams Conducting Retrospective Studies, by Year
  • Figure 6.2: Source of Data for Retrospective Studies
  • Figure 6.3: Objectives for Retrospective Studies

Retrospective Study Resources: Leverage Internal Expertise to Conserve Associated Costs

  • Figure 6.4: Difference in Planned and Actual Study Costs: Retrospective Studies
  • Figure 6.5: Percentage of Actual Study Costs Outsourced: Retrospective Studies
  • Figure 6.6: Percentage of Retrospective Studies That Outsource Certain Items
  • Figure 6.7: Number of Days Spent Recruiting and Selecting Vendors: Retrospective Studies
  • Figure 6.8: Number of Days Spent Negotiating Vendor Contracts: Retrospective Studies
  • Figure 6.9: Total Staffing for Retrospective Studies

Study Execution: Activity Timelines and Challenges

  • Figure 6.10: Stage When Study Planning and Execution Began: Retrospective Studies
  • Figure 6.11: Number of Days Spent from Study Planning to Protocol Approval: Retrospective Studies
  • Figure 6.12: Number of Days Spent from Protocol Approval to Data Lock: Retrospective Studies
  • Figure 6.13: Number of Days Spent from Data Lock to Submission of Manuscript for Publication: Retrospective Studies

Retrospective Study Profiles

  • Figure 6.14: Retrospective Study A: Background
  • Figure 6.15: Retrospective Study A: Costs and Outsourcing
  • Figure 6.16: Retrospective Study A: Staffing
  • Figure 6.17: Retrospective Study A: Study Timeline
  • Figure 6.18: Retrospective Study I: Background
  • Figure 6.19: Retrospective Study I: Costs and Outsourcing
  • Figure 6.20: Retrospective Study I: Staffing
  • Figure 6.21: Retrospective Study I: Study Timeline
  • Figure 6.22: Retrospective Study L: Background
  • Figure 6.23: Retrospective Study L: Costs and Outsourcing
  • Figure 6.24: Retrospective Study L: Staffing
  • Figure 6.25: Retrospective Study L: Study Timeline
  • Figure 6.26: Retrospective Study N: Background
  • Figure 6.27: Retrospective Study N: Costs and Outsourcing
  • Figure 6.28: Retrospective Study N: Staffing
  • Figure 6.29: Retrospective Study N: Study Timeline

Appendix

  • Table 1: Interventional Study Background Information
  • Table 2: Interventional Study Enrollment and Costs
  • Table 3: Observational Study Background Information
  • Table 4: Observational Study Enrollment and Costs
  • Table 5: Retrospective Study Background Information
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