Countries covered: United States, Europe
Whether building a better product profile, establishing comparative effectiveness or accomplishing any number of other objectives, post-marketing research grants companies a range of clinical and commercial benefits. Amid rigorous payer demands and competitive pressures, Phase IV studies are a growing necessity — but they often remain deprioritized and under-resourced as teams struggle to marshal needed support for both strategy and execution.
Use this study to reinforce Phase IV research and perfect study management. Examine benchmarks for US and EU data across major therapeutic areas and five trial types:
Integrate study planning and execution
Explore real-company structures as you work to maximize expertise and dissolve communication blocks. Clarify roles so that Phase IV objectives receive adequate attention.
Win post-marketing study resource support
Match your needs to trial size and scope — compare planned versus actual spending and peruse staffing tables for 51 real-world Phase IV trials. Track per patient budgets and headcounts by trial type, geography and company size. Along the way, learn strategies for balancing outsourcing with in-house capabilities to ensure consistent trial support and top performance.
Accelerate the trial timeline
Track timing using data broken down by study types, geography and nine key trial activities.
Measure performance
Discover the metrics top companies use to track performance and drive improvement in their Phase IV operations.
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- Chapter 1: Study Management Structure, Oversight and Strategy
- Chapter Benefits
- Ensure adequate infrastructure and support for Phase IV trials.
- Understand and designate clear roles for Phase IV strategy, management and execution.
- Benchmark patient enrollment numbers for specific therapeutic areas.
- Chapter Data
- 54 charts reveal Phase IV structure and strategy data in the US and EU:
- Examples of real-world structures for Phase IV program management
- Percentage of Phase IV work handled in-house
- Number of ongoing Phase IV studies, with breakdowns by trial type
- Departments included in Phase IV strategic development and execution
- Patient enrollment and average patients per investigator site across all therapeutic areas (comparative effectiveness trials, registries and observational trials, investigator initiated studies (IIS), large simple safety trials)
- Average patients per investigator site data for specific therapeutic areas (oncology, cardiovascular diseases, cardiology & thrombosis, CNS/neurology, vaccines, type 2 diabetes, musculoskeletal)
- Chapter 2: Phase IV Trial Timelines, Activities and Performance Metrics
- Chapter Benefits
- Target areas/activities that present opportunities to accelerate trials.
- Understand which trial types are being conducted where, and why.
- Learn which metrics other companies use to track Phase 4 trial performance.
- Understand the unique challenges patient enrollment presents in post-marketing research.
- Chapter Data
- 63 charts focused on trial execution and measurement:
- Percentage of drugs for which groups conduct Phase IV trials (in US and EU)
- Point at which US and EU groups initiate studies
- Average and percentage difference between planned versus actual trial duration
- Time consumed by key trial activities
- Planned versus actual enrollment
- Opportunities for accelerating trial timelines (in US and EU)
- Performance measurement self-ratings for study design & concept development, protocol development/writing, CRO/vendor selection, site selection/enrollment/contracting, patient enrollment, data collection and cleaning, and statistical analysis
- Percentage of companies tracking performance metrics (in US and EU), including efficiency/operations metrics, resource management metrics, time milestone metrics
- Weighted rankings of performance metrics and KPIs
- Chapter 3: Phase IV Study Budgets and Outsourcing
- Chapter Benefits
- Use real-company data to justify and win resources for your Phase IV programs.
- Benchmark costs for Phase IV trials in four major therapeutic areas.
- Examine real-company staffing data for 51 trials.
- Balance the benefits and disadvantages of Phase IV outsourcing trends.
- Chapter Data
- 49 charts and tables focusing on resource benchmarks for the five examined post-marketing trials:
- Average cost per patient for oncology, cardiovascular diseases, CNS/neurology, cardiology & thrombosis
- Staffing tables with in-house and outsourcing data for 12 clinical positions for 51 trials
- Average numbers of patients and investigator sites
- Average number of patients per CRA and patients per site ratios
- Average percentage of trial budgets outsourced
- Planned versus actual cost for IIS
- CHARTS AND GRAPHICS
- Executive Summary
- Phase 4 Clinical Trials: Key Findings
- Figure E.1: Patient Enrollment Stands as Largest Bottleneck in Phase 4 Trials
- Figure E.2: Company C’s Current Phase 4 Management Structure
- Figure E.3: Company C’s Planned Phase 4 Management Structure
- Figure E.4: Average Percentage of Phase 4 Trial Budgets Outsourced
- Figure E.5: Average Staffing Across 51 Phase 4 Trials
- Figure E.6: Percentage that Each Type of Study Represents of US Groups’ Total Phase 4 Trials
- Figure E.7: Percentage that Each Type of Study Represents of EU Groups’ Total Phase 4 Trials
- Study Management Structure, Oversight and Strategy
- Phase 4 Study Management Structure
- Figure 1.1: Centralization of Phase 4 Management (All Companies)
- Figure 1.2: Centralization of Phase 4 Management (US)
- Figure 1.3: Centralization of Phase 4 Management (EU)
- Figure 1.4: Percentage of Companies with Internal Resources to Conduct Phase 4 Trials In-House (All Companies)
- Figure 1.5: Percentage of Companies with Internal Resources to Conduct Phase 4 Trials In-House (US)
- Figure 1.6: Percentage of Companies with Internal Resources to Conduct Phase 4 Trials In-House (EU)
- Figure 1.7: Percentage of Companies with Internal Resources to Conduct Phase 4 Trials In-House (Large US)
- Figure 1.8: Percentage of Companies with Internal Resources to Conduct Phase 4 Trials In-House (Large EU)
- Figure 1.9: Percentage of Phase 4 Work Handled In-House by Companies with Available Infrastructure (All Companies)
- Figure 1.10: Company C’s Current Phase 4 Management Structure
- Figure 1.11: Company C’s Future Phase 4 Management Structure
- Figure 1.12: Company A’s Phase 4 Management Structure
- Figure 1.13: Company B’s Phase 4 Management Structure
- Defining Phase 4 Strategy
- Figure 1.14: Motivation for Ongoing Phase 4 Studies
- Figure 1.15: Top Reasons for Conducting Phase 4 Trials
- Figure 1.16: Percentage of Ongoing Studies by Type of Phase 4 Trial
- Figure 1.17: Departments Playing a Role in Phase 4 Strategic Development (All Companies)
- Figure 1.18: Departments Playing a Role in Phase 4 Strategic Development (US)
- Figure 1.19: Departments Playing a Role in Phase 4 Strategic Development (EU)
- Figure 1.20: How Executives Rate their Companies’ Performance at Designing/Planning Phase 4 Studies
- Figure 1.21: Departments Playing a Role in Phase 4 Execution (All Companies)
- Figure 1.22: Departments Playing a Role in Phase 4 Execution (US)
- Figure 1.23: Departments Playing a Role in Phase 4 Execution (EU)
- Figure 1.24: How Executives Rate their Companies’ Performance at Executing Phase 4 Studies
- Figure 1.25: Number of Ongoing Phase 4 Studies
- Phase 4 Patient Benchmarks
- Figure 1.26: Patient Enrollment for IIS
- Figure 1.27: Patient Enrollment for Comparative Effectiveness Trials
- Figure 1.28: Patient Enrollment for Registries and Observational Trials
- Figure 1.29: Average Patients per Investigator Site for IIS (All Therapeutic Areas)
- Figure 1.30: Average Patients per Investigator Site for Comparative Effectiveness Trials (All Therapeutic Areas)
- Figure 1.31: Average Patients per Investigator Site for Registries and Observational Trials (all Therapeutic Areas)
- Figure 1.32: Average Patients per Investigator Site for Large Simple Trials (All Therapeutic Areas)
- Figure 1.33: Average Patients per Investigator Site for Expanded Access Trials (All Therapeutic Areas)
- Figure 1.34: Average Patients per Investigator Site for IIT/IIS (Oncology)
- Figure 1.35: Average Patients per Investigator Site for Comparative Effectiveness Trials (Oncology)
- Figure 1.36: Average Patients per Investigator Site for Registries and Observational Trials (Oncology)
- Figure 1.37: Average Patients per Investigator Site for Large Simple Trials (Oncology)
- Figure 1.38: Average Patients per Investigator Site for IIS (Cardiovascular Diseases)
- Figure 1.39: Average Patients per Investigator Site for Comparative Effectiveness Trials (Cardiovascular Diseases)
- Figure 1.40: Average Patients per Investigator Site for Registries and Observational Trials (Cardiovascular
- Diseases)
- Figure 1.41: Average Patients per Investigator Site for Large Simple Trials (Cardiovascular Diseases)
- Figure 1.42: Average Patients per Investigator Site for Comparative Effectiveness Trials (Cardiology & Thrombosis)
- Figure 1.43: Average Patients per Investigator Site for Registries and Observational Trials (Cardiology and
- Thrombosis)
- Figure 1.44: Average Patients per Investigator Site for Large Simple Trials (Cardiology & Thrombosis)
- Figure 1.45: Average Patients per Investigator Site for IIS (Central Nervous System/Neurology)
- Figure 1.46: Average Patients per Investigator Site for Comparative Effectiveness Trials (Central Nervous System/
- Neurology)
- Figure 1.47: Average Patients per Investigator Site for Registries and Observational Trials (Central nervous system/
- Neurology)
- Figure 1.48: Average Patients per Investigator Site for Large Simple Trials (Central Nervous System/Neurology)
- Figure 1.49: Average Patients per Investigator Site for Registries and Observational Trials (Vaccines)
- Figure 1.50: Average Patients per Investigator Site for Comparative Effectiveness Trials (Vaccines)
- Figure 1.51: Average Patients per Investigator Site for Large Simple Trials (Vaccines)
- Figure 1.52: Average Patients per Investigator Site for Comparative Effectiveness Trials (Diabetes, Type 2)
- Figure 1.53: Average Patients per Investigator Site for Large Simple Trials (Diabetes, Type 2)
- Figure 1.54: Average Patients per Investigator Site for Comparative Effectiveness Trials (Musculoskeletal)
- Figure 2.1: Percentage of Surveyed Groups that Conduct Phase 4 Research on their Drugs Brought to Market
- Figure 2.2: Percentage of Drugs for Which Groups Conduct Phase 4 Trials (US)
- Post-Marketing Trial Timelines
- Figure 2.3: Percentage of Drugs for Which Groups Conduct Phase 4 Trials (EU)
- Figure 2.4: Percentage that Each Type of Study Represents of US Groups’ Total Phase 4 Trials
- Figure 2.5: Percentage of Groups Performing Phase 4 Studies by Type (US)
- Figure 2.6: Percentage that Each Type of Study Represents of EU Groups’ Total Phase 4 Trials
- Figure 2.7: Percentage of Groups Performing Phase 4 Studies by Type (EU)
- Figure 2.8: Point at Which US Groups Initiate IIT/IIS
- Figure 2.9: Point at Which US Groups Initiate Comparative Effectiveness Studies
- Figure 2.10: Point at Which US Groups Initiate Initiate Registries and Observational Studies
- Figure 2.11: Point at Which US Groups Initiate Large Simple Safety Studies
- Figure 2.12: Point at Which US Expanded Access Studies
- Figure 2.13: Point at Which EU Groups Initiate IIS
- Figure 2.14: Point at Which EU Groups Initiate Comparative Effectiveness Studies
- Figure 2.15: Point at Which EU Groups Initiate Initiate Registries and Observational Studies
- Figure 2.16: Point at Which EU Groups Initiate Large Simple Safety Studies
- Figure 2.17: Point at Which EU Expanded Access Studies
- Figure 2.18: Average Planned Versus Actual Duration for IIS
- Figure 2.19: Percentage Difference Between Planned and Actual Duration for IIS
- Figure 2.20: Average Planned Versus Actual Duration for Comparative Effectiveness Trials
- Figure 2.21: Percentage Difference between Planned and Actual Duration for Comparative Effectiveness Trials
- Figure 2.22: Average Planned Versus Actual Duration for Registries and Observational Trials
- Figure 2.23: Percentage Difference Between Planned and Actual Duration for Registries and Observational Trials
- Figure 2.24: Average Planned Versus Actual Duration for Large Simple Safety Trials
- Figure 2.25: Percentage Difference Between Planned and Actual Duration for Large Simple Safety Trials
- Figure 2.26: Percentage Difference Between Planned and Actual Duration for Expanded Access Trials
- Figure 2.27: Percentage Difference Between Planned and Actual Duration for Expanded Access Trials
- Post-Marketing Trial Activities
- Figure 2.28: Percentages of Time Consumed by Trial Activities: IIS
- Figure 2.29: Percentages of Time Consumed by Trial Activities: Comparative Effectiveness Trials
- Figure 2.30: Percentages of Time Consumed by Trial Activities: Registries and Observational Trials
- Figure 2.31: Percentages of Time Consumed by Trial Activities: Large Simple Safety Trials
- Figure 2.32: Percentages of Time Consumed by Trial Activities: Expanded Access Programs/Trials
- Figure 2.33: Planned Versus Actual Enrollment for IIS
- Figure 2.34: Percentage Difference Between Planned and Actual Enrollment for IIS Trials
- Figure 2.35: Planned Versus Actual Enrollment for Comparative Effectiveness Trials
- Figure 2.36: Percentage Difference Between Planned and Actual Enrollment for Comparative Effectiveness Trials
- Figure 2.37: Planned Versus Actual Enrollment for Registries and Observational Trials
- Figure 2.38: Percentage Difference Between Planned and Actual Enrollment for Registries and Observational Trials
- Acceleration Opportunities for Phase 4 Trials
- Figure 2.39: Opportunities for Accelerating Trial Timelines (All Companies)
- Figure 2.40: Opportunities for Accelerating Trial Timelines (US)
- Figure 2.41: Opportunities for Accelerating Trial Timelines (EU)
- Company Self-Ratings: Performance in Planning and Executing Phase 4 Studies
- Figure 2.42: Performance Measurement Self-Ratings: Study Design & Concept Development
- Figure 2.43: Performance Measurement Self-Ratings: Protocol Development/Writing
- Figure 2.44: Performance Measurement Self-Ratings: CRO/Vendor Selection
- Figure 2.45: Performance Measurement Self-Ratings: CRO/Vendor Contracting
- Figure 2.46: Performance Measurement Self-Ratings: Site Selection/Enrollment/Contracting
- Figure 2.47: Performance Measurement Self-Ratings: Patient Enrollment
- Figure 2.48: Performance Measurement Self-Ratings: Data Collection and Cleaning
- Figure 2.49: Performance Measurement Self-Ratings: Statistical Analysis
- Figure 2.50: How Executives Rate Their Companies’ Performance at Measuring Phase 4 Performance
- Figure 2.51: How Executives Rate Their Companies’ Performance at Using Performance Measurement to Effect
- Organizational Change
- Figure 2.52: Percentage of Companies Tracking Efficiency/Operations Performance Metrics (All Companies)
- Figure 2.53: Percentage of Companies Tracking Efficiency/Operations Performance Metrics (US)
- Figure 2.54: Percentage of Companies Tracking Efficiency/Operations Performance Metrics (EU)
- Figure 2.55: Percentage of Companies Tracking Resource Metrics (All Companies)
- Figure 2.56: Percentage of Companies Tracking Resource Metrics (US)
- Figure 2.57: Percentage of Companies Tracking Resource Metrics (EU)
- Figure 2.58: Percentage of Companies Tracking Time Milestone Metrics (All Companies)
- Figure 2.59: Percentage of Companies Tracking Time Milestone Metrics (US)
- Figure 2.60: Percentage of Companies Tracking Time Milestone Metrics (EU)
- Figure 2.61: Percentage of Companies that Rate KPIs among the Top Five KPI’s Used by their Company
- Figure 2.62: Average Rating of KPIs Among Companies that Actually Measure each KPI
- Figure 2.63: Weighted Rankings of KPIs Taking into Account Percentage of Companies Using Measures and
- Rankings From 1 to 5
- Phase 4 Study Budgets and Outsourcing
- Figure 3.1: Average Cost per Patient for IIS in the US (All Therapeutic Areas)
- Figure 3.2: Average Cost per Patient for IIS in the EU (All Therapeutic Areas)
- Figure 3.3: Average Cost per Patient for IIS (Oncology)
- Figure 3.4: Average Cost per Patient for IIS (Cardiovascular Diseases)
- Figure 3.5: Average Cost per Patient for IIS (Central Nervous System/Neurology)
- Figure 3.6: Average Cost per Patient for IIS (Other Therapeutic Areas)
- Figure 3.7: Average Cost per Patient for Comparative Effectiveness Trials in the US (All Therapeutic Areas)
- Figure 3.8: Average Cost per Patient for Comparative Effectiveness Trials in the EU (All Therapeutic Areas)
- Figure 3.9: Average Cost per Patient for Comparative Effectiveness Trials (Oncology)
- Figure 3.10: Average Cost per Patient for Comparative Effectiveness Trials (Cardiovascular Diseases)
- Figure 3.11: Average Cost per Patient for Comparative Effectiveness Trials (Cardiology & Thrombosis)
- Figure 3.12: Average Cost per Patient for Comparative Effectiveness Trials (Other Therapeutic Areas)
- Figure 3.13: Average Cost per Patient for Registries and Observational Trials in the US (All Therapeutic Areas)
- Figure 3.14: Average Cost per Patient for Registries and Observational Trials in the EU (All Therapeutic Areas)
- Figure 3.15: Average Cost per Patient for Registries and Observational Trials (Oncology)
- Figure 3.16: Average Cost per Patient for Registries and Observational Trials (Central Nervous System/Neurology)
- Figure 3.17: Average Cost per Patient for Registries and Observational Trials (Other Therapeutic Areas)
- Figure 3.18: Average Cost per Patient for Large Simple Safety Trials in the US (All Therapeutic Areas)
- Figure 3.19: Average Cost per Patient for Large Simple Safety Trials in the EU (All Therapeutic Areas)
- Figure 3.20: Percentage of Companies with Internal Resources to Conduct Phase 4 Trials In-House (US)
- Figure 3.21: Percentage of Companies with Internal Resources to Conduct Phase 4 Trials In-House (EU)
- Figure 3.22: Average Percentage of Comparative Effectiveness Trial Budgets Outsourced
- Figure 3.23: Average Percentage of Registries and Observational Trial Budgets Outsourced
- Figure 3.24: Average Percentage of Large Simple Safety Trial Budgets Outsourced
- Figure 3.25: Average Percentage of Expanded Access Trial Budgets Outsourced
- Figure 3.26: Planned Versus Actual Cost for IIS
- Figure 3.27: Percentage Difference Between Planned and Actual Cost for IIS
- Figure 3.28: Planned Versus Actual Cost for Comparative Effectiveness Trials
- Figure 3.29: Percentage Difference Between Planned and Actual Cost for Comparative Effectiveness Trials
- Figure 3.30: Planned Versus Actual Cost for Registries and Observational Trials
- Figure 3.31: Percentage Difference Between Planned and Actual Cost for Registries and Observational Trials
- Phase 4 Trial Staffing
- Figure 3.32: Average Numbers of Patients and Investigator Sites in Trials Staffing Data
- Figure 3.33: Average Number of Patients per CRA and Patients per Site Ratios in Trials Staffing Data
- Figure 3.34: Average Patients per CRA by Trial Type
- Table 3.1: Average Phase 4 Trial Staffing Across All Therapeutic Areas (FTEs)
- Table 3.2: Phase 4 Trials (Trials 1-4)
- Table 3.3: Phase 4 Trials (Trials 5-8)
- Table 3.4: Phase 4 Trials (Trials 9-12)
- Table 3.5: Phase 4 Trials (Trials 13-16)
- Table 3.6: Phase 4 Trials (Trials 17-20)
- Table 3.7: Phase 4 Trials (Trials 21-24)
- Table 3.8: Phase 4 Trials (Trials 25-28)
- Table 3.9: Phase 4 Trials (Trials 29-32)
- Table 3.10: Phase 4 Trials (Trials 33-36)
- Table 3.11: Phase 4 Trials (Trials 37-40)
- Table 3.12: Phase 4 Trials (Trials 41-44)
- Table 3.13: Phase 4 Trials (Trials 45-48)
- Table 3.14: Phase 4 Trials (Trials 49-51)
- Table 3.15: Average Phase 4 Trial Staffing by Therapeutic Area (FTEs)
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