Streamlining Clinical Trials

Table of Contents

Executive Summary

• Report Findings: Current and Future Trends
• Study Methodology
• Profiled Companies
• Clinical Operations : Principles for Success
• Clinical Trials Resource Allocation
• Per Patient Costs and Outsourced Spending
• Therapeutic Area Costs per Patient
• Clinical Operations Budgeting Process
• Phase-by-Phase Clinical Staffing Metrics
• Other Staffing Metrics

Clinical Trial Performance Measurement

• Clinical Trial Performance Tracked

Continuous Process Improvement

• Study Planning and Set Up
• Study Conduct
• Study Analysis and Close out

Recruiting and Retaining Patients and Investigator

• Enrolling Patients through Effective Recruitment Methods
• Patient Retention and Compliance
• Investigator Recruitment and Incentives
• Adaptive Clinical Trial Design

CHARTS AND GRAPHICS

Executive Summary

• Figure E.1: Percentages of Planned Timelines that Trials Exceed by Phase
• Figure E.2: Average Per Patient Clinical Trial Costs Across Therapeutic Areas (by Phase, US)
• Figure E.3: Phase 1: Average Staffing by Position
• Figure E.4: Phase 2: Average Staffing by Position
• Figure E.5: Phase 3: Average Staffing by Position
• Figure E.6: Percentage of In-House and Outsourced Staff by Phase
• Figure E.7: How Trial Activities Have Changed as a Percentage of the Clinical Development Timeline Over the Past Five Years

Clinical Trials Resource Allocation

• Figure 1.1: Factors Impacting Rising Clinical Development Costs in US (2008 vs. 2006 vs. 2004)
• Figure 1.2: Average Per-Patient Clinical Trial Cost Across Therapeutic Areas (by Phase, US)
• Figure 1.3: Average Per-Patient Clinical Trial Cost Across Therapeutic Areas (by Phase, US 2006)
• Figure 1.4: Percentage of Clinical Development Budget Outsourced, as Average Across Therapeutic Areas (by Phase, US)
• Figure 1.5: Percentage of Clinical Development Budget Outsourced, as Average Across Therapeutic Areas (by Phase, US 2006)
• Figure 1.6: Total Trial Staffing by Phase
• Table 1.1: Average Phase-by-Phase Staffing by Clinical Function
• Figure 1.7: Percentage of In-House and Outsourced Staff by Phase
• Figure 1.8: Percentage of In-House and Outsourced Staff by Phase (2006)

Per Patient Costs and Outsourced Spending

• Figure 1.9: Phase 1: Per-Patient Clinical Trial Cost (by Therapeutic Area, US)
• Figure 1.10: Phase 1: Per-Patient Clinical Trial Cost (by Therapeutic Area,US 2006)
• Figure 1.11: Phase 2: Per-Patient Clinical Trial Cost (by Therapeutic Area, US)
• Figure 1.12: Phase 2: Per-Patient Clinical Trial Cost (by Therapeutic Area, US 2006)
• Figure 1.13: Phase 3a: Per-Patient Clinical Trial Cost (by Therapeutic Area, US)
• Figure 1.14: Phase 3b: Per-Patient Clinical Trial Cost (by Therapeutic Area, US)
• Figure 1.15: Phase 3: Per-Patient Clinical Trial Cost (by Therapeutic Area, US 2006)
• Figure 1.16: Phase 4: Per-Patient Clinical Trial Cost (by Therapeutic Area, US)
• Figure 1.17: Phase 4: Per-Patient Clinical Trial Cost (by Therapeutic Area, US 2006)
• Figure 1.18: Percentage of Clinical Development Budget Outsourced by Phase (US)
• Figure 1.19: Phase 1: Percentage of Clinical Development Budget Outsourced (by Therapeutic Area, US)
• Figure 1.20: Phase 1: Percentage of Clinical Development Budget Outsourced (by Therapeutic Area, US 2006)
• Figure 1.21: Phase 2: Percentage of Clinical Development Budget Outsourced (by Therapeutic Area, US)
• Figure 1.22: Phase 2: Percentage of Clinical Development Budget Outsourced (by Therapeutic Area, US 2006)
• Figure 1.23: Phase 3: Percentage of Clinical Development Budget Outsourced (by Therapeutic Area, US)
• Figure 1.24: Phase 3: Percentage of Clinical Development Budget Outsourced (by Therapeutic Area, US 2006)
• Figure 1.25: Phase 4: Percentage of Clinical Development Budget Outsourced (by Therapeutic Area, US)
• Figure 1.26: Phase 4: Percentage of Clinical Development Budget Outsourced (by Therapeutic Area, US 2006)
• Figure 1.27: Cost-Savings of Clinical Trials in India

Therapeutic Area Costs per Patient

• Figure 1.28: Phase 1: Per Patient Clinical Trial Costs (Autoimmune, US)
• Figure 1.29: Phase 2: Per Patient Clinical Trial Costs (Autoimmune, US)
• Figure 1.30: Phase 3a: Per Patient Clinical Trial Costs (Autoimmune, US)
• Figure 1.31: Phase 1: Per Patient Clinical Trial Costs (Cardio & Thrombosis, US)
• Figure 1.32: Phase 2: Per Patient Clinical Trial Costs (Cardio & Thrombosis, US)
• Figure 1.33: Phase 3a: Per Patient Clinical Trial Costs (Cardio & Thrombosis, US)
• Figure 1.34: Phase 3b: Per Patient Clinical Trial Costs (Cardio & Thrombosis, US)
• Figure 1.35: Phase 4: Per Patient Clinical Trial Costs (Cardio & Thrombosis, US)
• Figure 1.36: Phase 1: Per Patient Clinical Trial Costs (CNS/Psychology, US)
• Figure 1.37: Phase 2: Per Patient Clinical Trial Costs (CNS/Psychology, US)
• Figure 1.38: Phase 3a: Per Patient Clinical Trial Costs (CNS/Psychology, US)
• Figure 1.39: Phase 3b: Per Patient Clinical Trial Costs (CNS/Psychology, US)
• Figure 1.40: Phase 4: Per-Patient Clinical Trial Costs(CNS/Psychology, US)
• Figure 1.41: Phase 1: Per Patient Clinical Trial Costs (Infectious Diseases, US)
• Figure 1.42: Phase 2: Per Patient Clinical Trial Costs (Infectious Diseases, US)
• Figure 1.43: Phase 3a: Per Patient Clinical Trial Costs (Infectious Diseases, US)
• Figure 1.44: Phase 3b: Per Patient Clinical Trial Costs (Infectious Diseases, US)
• Figure 1.45: Phase 4: Per Patient Clinical Trial Costs (Infectious Diseases, US)
• Figure 1.46: Phase 1: Per Patient Clinical Trial Costs (Oncology, US)
• Figure 1.47: Phase 2: Per Patient Clinical Trial Costs (Oncology, US)
• Figure 1.48: Phase 3a: Per Patient Clinical Trial Costs (Oncology, US)
• Figure 1.49: Phase 3b: Per-Patient Clinical Trial Costs (Oncology, US)
• Figure 1.50: Phase 4: Per Patient Clinical Trial Costs (Oncology, US)
• Figure 1.51: Percentage of Clinical Development Budget Outsourced /Autoimmune, US)
• Figure 1.52: Percentage of Clinical Development Budget Outsourced /Autoimmune, US 2006)
• Figure 1.53: Percentage of Clinical Development Budget Outsourced /Cardio & Thrombosis, US)
• Figure 1.54: Percentage of Clinical Development Budget Outsourced /Cardio & Thrombosis, US 2006)
• Figure 1.55: Percentage of Clinical Development Budget Outsourced /CNS/Psychology, US)
• Figure 1.56: Percentage of Clinical Development Budget Outsourced /CNS/Psychology,US 2006)
• Figure 1.57: Percentage of Clinical Development Budget Outsourced /Dermatology, US)
• Figure 1.58: Percentage of Clinical Development Budget Outsourced (Infectious Diseases, US)
• Figure 1.59: Percentage of Clinical Development Budget Outsourced (Infectious Diseases, US 2006)
• Figure 1.60: Percentage of Clinical Development Budget Outsourced (Oncology, US)
• Figure 1.61: Percentage of Clinical Development Budget Outsourced (Oncology, US 2006)

Phase-by-Phase Clinical Staffing

• Figure 1.62: Phase 1: Total Trial Staffing by Phase
• Figure 1.63: Phase 1: Average Staffing by Position: In-House versus Outsourced FTts
• Figure 1.64: Phase 1: Percentage Breakdown: In-House vs. Outsourced Staffing
• Figure 1.65: Phase 1: Percentage Breakdown: In-House vs. Outsourced Staffing (2006)
• Figure 1.66: Phase 1: Trials: Patients per CRA
• Table 1.2: Phase 1 Clinical Trial Staffing
• Figure 1.67: Phase 2: Average Staffing by Position: In-House versus Outsourced FTts
• Figure 1.68: Phase 2 Percentage Breakdown: In-House vs. Outsourced Staffing
• Figure 1.69: Phase 2 Percentage Breakdown: In-House vs. Outsourced Staffing (2006)
• Figure 1.70: Phase 2 Trials: Patients per CRA
• Figure 1.71: Phase 2 Trials: Average Patients Per CRA Ratios by Company Size
• Table 1.3: Phase 2 Clinical Trials Staffing
• Table 1.3: Phase 2 Clinical Trials Staffing (continued)
• Table 1.3: Phase 2 Clinical Trials Staffing (continued)
• Table 1.3: Phase 2 Clinical Trials Staffing (continued)
• Table 1.3: Phase 2 Clinical Trials Staffing (continued)
• Figure 1.72: Phase 3: Average Staffing by Position: In-House vs. Outsourced FTEs
• Figure 1.73: Phase 3 Percentage Breakdown: In-House vs. Outsourced Staffing
• Figure 1.74: Phase 3 Percentage Breakdown: In-House vs. Outsourced Staffing (2006)
• Figure 1.75: Phase 3 Trials: Patients per CRA
• Figure 1.76: Phase 3 Trials: Average Patients Per CRA Ratios by Company Size
• Table 1.4: Phase 3 Clinical Trials Staffing
• Table 1.4: Phase 3 Clinical Trials Staffing (continued)
• Table 1.4: Phase 3 Clinical Trials Staffing (continued)
• Table 1.4: Phase 3 Clinical Trials Staffing (continued)
• Table 1.4: Phase 3 Clinical Trials Staffing (continued)
• Figure 1.77: Phase 4: Average Staffing by Position: In-House vs. Outsourced FTEs
• Figure 1.78: Phase 4 Percentage Breakdown: In-House vs. Outsourced Staffing
• Figure 1.79: Phase 4 Percentage Breakdown: In-House vs. Outsourced Staffing (2006)
• Figure 1.80: Phase 4 Trials: Patients per CRA
• Table 1.5: Phase 4 Clinical Trials Staffing
• Figure 1.81: Ratio of Sites per CRA

Other Staffing Metrics

• Figure 1.82: Percentage of Staffing Outsourced by Phase : Clinical Program Directors/VPs/TA Leaders
• Figure 1.83: Percentage of Staffing Outsourced by Phase : Trial Managers
• Figure 1.84: Percentage of Staffing Outsourced by Phase : CRAs/Monitors
• Figure 1.85: Percentage of Staffing Outsourced by Phase : Data Management
• Figure 1.86: Percentage of Staffing Outsourced by Phase : Medical Writing
• Figure 1.87: Percentage of Staffing Outsourced by Phase : Biostatistics/Bioanalytics
• Figure 1.88: Percentage of Staffing Outsourced by Phase : Regulatory
• Figure 1.89: Percentage of Staffing Outsourced by Phase : Clinical Qualify Assurance
• Figure 1.90: Percentage of Staffing Outsourced by Phase : Clinical Trials Supplies
• Figure 1.91: Percentage of Staffing Outsourced by Phase : CMC
• Figure 1.92: Percentage of Staffing Outsourced by Phase : Contract Management
• Figure 1.93: Percentage of Staffing Outsourced by Phase : Drug Safety
• Figure 1.94: Percentage of Staffing Outsourced by Phase : Pharmacovigilance

Clinical Trial Performance Measurement

Clinical Trial Performance Metrics Tracked

• Figure 2.1: Performance Measures Tracked During and Average Phase 3 Clinical Trial: Time Milestones
• Figure 2.2: Performance Measures that Impact Organizational Change: Time Milestones
• Figure 2.3: Performance Measures Tracked During and Average Phase 3 Clinical Trial : Resources (Budgets & Staffing )
• Figure 2.4: Performance Measures that Impact Organizational Change: Resources Resources (Budgets & Staffing)
• Figure 2.5: Performance Measures Tracked During and Average Phase 3 Clinical Trial: Efficiency/Operational Performance
• Figure 2.6: Performance Measures that Impact Organizational Change:

Continuous Process Improvement

Study Planning and Set Up

• Figure 3.1: Impact of Narrowing Data Collection Targets Early in Clinical Trials
• Figure 3.2: Opportunities for Trial Acceleration: Investigator and CRO/Vendor Contracting
• Figure 3.3: Solving the Non-Disclosure Agreement Bottleneck

Recruiting and Retaining Patients and Investigators

• Figure 4.1: Factors Impacting Rising Clinical Development Costs in US
• Figure 4.2: Average Number of Patients Per Trial: Phase 1

Enrolling Patients through Effective Recruitment Methods

• Figure 4.3: Average Number of Patients Per Trial: Phase 2(by Therapeutic Area)
• Figure 4.4: Average Number of Patients Per Trial: Phase 3(by Therapeutic Area)
• Figure 4.5: Average Number of Patients Per Trial: Phase 4
• Figure 4.6: Average Number of Patients Per Site: Phase 1(by Therapeutic Area)
• Figure 4.7: Average Number of Patients Per Site: Phase 2(by Therapeutic Area)
• Figure 4.8: Average Number of Patients Per Site: Phase 3(by Therapeutic Area)
• Figure 4.9: Percentages of Time Consumed by Trial Activities
• Figure 4.1O: Top Clinical Trial Bottlenecks
• Figure 4.11: How Trial Activities Have Changed as a Percentage of the Clinical Development Timeline Over the Last 5 Years
• Figure 4.12: Opportunities for Trial Acceleration
• Figure 4.13: Marketing Tactics' Impacts on Patient Recruitment
• Figure 4.14: Patient Recruitment Referral Tools
• Figure 4.15: The Patient Recruitment Funnel
• Figure 4.16: Web-Based Patient Recruitment Options
• Figure 4.17: Search Engine Optimization Strategies

Patient Retention and Compliance

• Figure 4.18: Patient Recruitment Incentives
• Figure 4.19: Percentages of Time Consumed by Trial Activities

Investigator Recruitment and Incentives

• Figure 4.20: Opportunities for Trial Acceleration
• Figure 4.21: Investigator Recruitment Tools/Incentives
• Figure 4.22: Per Patient Investigator Incentive Model

Adaptive Clinical Trial Design

• Figure 5.1: Percentage of Participating Companies Performing Adaptive Trials Design
• Figure 5.2: Rating Adaptive Clinical Trials Design Effectiveness versus Traditional Clinical Trials Design
• Figure 5.3: Advantages/Disadvantages of Adaptive Clinical Trials Design according to Participants