Streamlining Clinical Trials

SUMMARY

Refine processes to accelerate and improve clinical trials

Executing a successful clinical trial requires seamless communication and coordination among many stakeholders- study sponsors, contract research organizations, academic research organizations, site management organizations, patient recruiters, clinical investigators and patients.

Research shows that there is much room for improvement. The average Phase 1, 2, and 3 trials exceed their timelines by 20%. Delays in the clinical trial process cost pharma companies hundreds of thousands - even millions - in sales. Today, companies also encounter formidable challenges in the clinical development process, including the FDA's increased involvement.

Streamlining Clinical Trials is the authoritative tool for clinical operations teams to accelerate their trials. This comprehensive guide delves into the latest industry trends and strategies for elevating efficiency. It focuses on resource allocation, performance measurement, continuous process improvement, patient and investigator recruitment and adaptive trial designs. Through extensive benchmarking data, real-company case studies and interviews with industry experts, the report shows how companies are moving their product candidates through development faster and more efficiently.

Use the report to:

• Benchmark your clinical operations against leading companies
• Clarify performance objectives
• Identify and eliminate common trial bottlenecks
• Drive successful patient recruitment campaigns
• Plan study design and protocol effectively
• Discover and apply innovative patient and investigator retention strategies
• Weigh the pros and cons of adaptive trial designs versus traditional trials

Companies Included in Report

• Abbott Labs
• Allergan
• Amgen
• AstraZeneca
• Baxter Healthcare
• Bristol-Myers Squibb
• Covance
• Cephalon
• CSP
• EmpiriStat
• Genzyme
• Gilead Sciences
• Medarex
• Merck
• Millennium Pharmaceuticals
• Neurogen
• Nycomed
• Onyx Pharmaceuticals
• Ortho-McNeil Janssen
• PDL Biopharma
• Pfizer
• Pharma Consulting Solutions
• PPD
• ResearchLink
• Sanofi-Aventis
• Schering-Plough
• Teva
• UCB Pharmaceuticals

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