Table of Contents
Executive Summary
- Study Methodology and Definifions
- Profiled Companies and Therapeufic Areas
- Phase 4 Clinical Trials: Conclusions and Recommendations
Study Management Structure, Oversight and Strategy
- Phase 4 Study Management Structure
- Developing a Phase 4 Strategy
Phase 4 Trial timelines, Activities and Performance Metrics
- Post-Marketing Trial timelines
- Post-Marketing Trial Activities
- Performance Measurement
Budgets, Statfing and Outsourcing
- Phase 4 Study Budgets and Outsourcing
- Phase 4 Trial Stafing
CHARTS & GRAPHICS
Executive Summary
- Figure E.1: Percentage of Phase 4 Clinical Trial Budgets Outsourced, by
Therapeutic Area
- Figure E.2: Percentage of Phase 4 Studies for Which Survey Respondents
Submitted
- ASRs to FDA, 2005 and 2006
Study Management Sfructure. Oversight and Strategy
- Phase 4 Study Management Structure
- Figure 1.1: Phase 4 Study Management Structure
- Figure 1.2: Phase 4 Study Management Structure by Company Size
- Figure 1.3: Company 7' s Phase 4 Management Structure
- Figure 1.4: Company 12' s Phase 4 Management Structure
- Figure 1.5: Total Number of Patients per Therapeutic Area
- Figure 1.6: Average Number of Patients per Therapeutic Area Trial by
Company Size
- Figure 1.7: Number of Patients per Site
- Figure 1.8: Average Number of Patients per Site by Company Size
- Figure 1.9: Percentage of In-House Phase 4 Infrastructures
- Figure 1.10: Percentage of In-House Phase 4 Infrastructures by Company
Size
- Figure 1.11: Percentage of Companies that Outsource Phase 4 Activities
- Figure 1.12: Percentage of Companies that Outsource Phase 4 Activities
by Company Size
- Developing a Phase 4 Strategy
- Figure 1.13: Motivation for Conducting Phase 4 Studies
- Figure 1.14: Average Number of Active Studies Per Motivation Category
- Figure 1.15: Number of Active Phase 4 Studies by Company
- Figure 1.16: Number of Active Phase 4 Studies Per Marketed Product by
Company
- Figure 1.17: Average Number of Active Phase 4 Studies Per Marketed
Product by Company Size
- Figure 1.18: Percentage Breakdown for Phase 4 Motivation by Company Size
- Figure 1.19: Average Number of Active Phase 4 Trials by Motivation and
Company Size
- Figure 1.20: Number of Active Phase 4 Studies Per Small Company
- Figure 1.21: Number of Active Phase 4 Studies Per Mid-Size Company
- Figure 1.22: Number of Active Phase 4 Studies Per Large Company
- Figure 1.23: Key Motivating Factors for Conducting Phase 4 Studies
- Figure 1.24: Functional Oversight of Phase 4 Study Strategy
- Figure 1.25: Functional Oversight of Phase 4 Study Strategy by Company
Size
- Figure 1.26: Participants' Self-Asse ssm e n ts of Study Pla nn ing and
Design
- Figure 1.27: Functional Oversight of Phase 4 Study Execution
- Figure 1.28: Functional Oversight of Phase 4 Study Strategy by Company
Size
- Figure 1.29: Participants' Self-Assessments of Study Execution
- Table 1.1: Participating Companies' Phase 4 Study Challenges
Phase 4 Trial Timelines, Activities and Performance Metrics
- Post-Marketing Trial Timelines
- Figure 2.1: Percentage of NDAs with At Least One Post-Marketing Study C
o m m itm e nt
- Table 2.1: Post-Marketing Study Commitments (September 2005, FDA Federal
Register)
- Table 2.2: Post-Marketing Study Commitments from Fiscal Years 1990-2004
- Figure 2.2: Products with Post-Marketing Studies Conducted
- Figure 2.3: Products with Post-Marketing Studies Conducted by Company
Size
- Figure 2.4: Phase 4 Studies Initiated by All Surveyed Companies
- Figure 2.5: Phase 4 Studies Initiated by Small Companies
- Figure 2.6: Phase 4 Studies Initiated by Mid -Size Companies
- Figure 2.7: Phase 4 Studies Initiated by Large Companies
- Figure 2.8: Phase 4 Average & Projected Trial Duration
- Figure 2.9: Percentage of Da ys Be yo nd Average Phase 4 Trial D ura tio
n
- Figure 2.10: Company Sponsored vs. Investigator Sponsored Post-Marketing
US Studies
- Post-Marketing Trial Activities
- Figure 2.11: Percentage s of Tim e Consumed by Trial Activities: Overall
Average
- Figure 2.12: Percentage s of Tim e Consumed by Trial Activities: Small
Companies
- Figure 2.13: Percentage s of Tim e Consumed by Trial Activities:
Mid-Size Companies
- Figure 2.14: Percentage s of Tim e Consumed by Trial Activities: Large
Companies
- Figure 2.15: Opportunities for Trial Acceleration : Overall Average
- Figure 2.16: Opportunities for Trial Acceleration : Small Companies
- Figure 2.17: Opportunities for Trial Acceleration : Mid-Size Companies
- Figure 2.18: Opportunities for Trial Acceleration : Large Companies
- Figure 2.19: Overall Performance Measurement Self-Ratings: All Activities
- Figure 2.20: Performance Measurement Self-Ratings: Study Design &
Concept Development
- Figure 2.21: Performance Measurement Self-Ratings: Protocol
Development/W riting
- Figure 2.22: Performance Measurement Self-Ratings: Site Selection
/Enrollment/Contracting
- Figure 2.23: Performance Measurement Self-Ratings: Patient Enrollment
- Figure 2.24: Performance Measurement Self-Ratings: CRO /Vendor Protocol
- Figure 2.25: Performance Measurement Self-Ratings: CRO /Vendor
Contracting
- Figure 2.26: Performance Measurement Self-Ratings: Data Collection &
Cleaning
- Figure 2.27: Performance Measurement Self-Ratings: Statistical Analysis
- Performance Measurement
- Figure 2.28: Self-Ratings: Measuring Performance
- Figure 2.29: Self-Ratings: Using Performance Measurement to Effect
Organizational Change
- Figure 2.30: Self-Ratings: Measuring Performance (by Company Size )
- Figure 2.31: Self-Ratings: Usin g Performance Measurement to Effect
Organizational Change (by Company Size )
- Figure 2.32: Percentage of Companies Tracking Efficiency/Operations
Performance Metrics
- Figure 2.33: Percentage of Companies Tracking Resource Metrics
- Figure 2.34: Percentage of Companies Tracking Time Milestone Metrics
- Table 2.3: Phase 4 Performance Metrics - Average Performance
- Table 2.4: Phase 4 Performance Metrics - Target Performance
- Table 2.5: Additional Phase 4 Performance Measures
Budgets, Staffing and Outosourcing
- Phase 4 Study Budgets and Outsourcing
- Figure 3.1: Percentage of Total R& D Spending Allocated to Phase 4
Trials, by Company
- Figure 3.2: Percentage of Total R& D Spending Allocated to Phase 4
Trials, by Company Size
- Figure 3.3: Average Cost Per Patient of Phase 4 Clinical Trials in the
US, by Therapeutic Area
- Figure 3.4: Percentage of In-House Phase 4 Infrastructures
- Figure 3.5: Percentage of In-House Phase 4 Infrastructures, by Company
Size
- Figure 3.6: Percentage of Phase 4 Clinical Trial Budgets Outsourced , by
Therapeutic Area
- Phase 4 Trial Staffing
- Figure 3.7: Average Numbers of Patients and Investigator Sites in Phase
4 Stafing Data
- Figure 3.8: Average Patients-Per-Site and Patients-Per-CRA Ratios in
Phase 4 Staffing Data
- Table 3.1: Average Phase 4 Trial Stafing Across All Therapeutic
Areas(FTEs)
- Table 3.2: Phase 4 Trials (Trials 1-3)
- Table 3.3: Phase 4 Trials: (Trials 4-6)
- Table 3.4: Phase 4 Trials: (Trials 7-10)
- Table 3.5: Phase 4 Trials: (Trials 11-14)
- Table 3.6: Phase 4 Trials: (Trials 15-19)
- Table 3.7: Phase 4 Trials: (Trials 20-23)
- Table 3.8: Phase 4 Trials: (Trials 24-28)
- Table 3.9: Phase 4 Trials: (Trials 29-31)
- Table 3.10: Phase 4 Trials: (Trials 32-34)
- Table 3.11: Phase 4 Trials: (Trials 35-39)
- Figure 3.9: Average Patient Counts of Therapeutic Area-Specific Trials
- Table 3.12: Average Phase 4 Trial Stafing by Therapeulic Area (FTEs)
- Figure 3.10: Percentage of Staff Outsourced by Product Type
- Table 3.13: Average Phase 4 Trial Stafing by Roduct Type (FTEs)
- Figure 3.11: Average Patient Counts of Company Size-Specific Trials
- Figure 3.12: Patients Per FTE by Company Size
- Table 3.14: Average Phase 4 Trial Stafing by Company Size(FTEs)
- Table 3.15: Average Phase 4 Trial Stafing by Trial Management Approach
(FTEs)
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