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Patient Recruitment and Retention in Clinical Trials: Emerging strategies in Europe, the US and Asia


Patient Recruitment and Retention in Clinical Trials: Emerging strategies in Europe, the US and Asia

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Additional Information
Price $2,875.00
Meta Description No
Publisher Business Insights
Date of Report Jun 20, 2011
Quick Overview
Patient Recruitment and Retention in Clinical Trials
Operational delays in clinical trials reduce patent exclusivity time and shorten the most commercially productive
phase of a product’s life cycle, resulting in millions of dollars in missed market opportunities for potential
blockbusters. The primary source of such delays is the recruitment and retention of patients that fit the trials’ profile
requirements.
More and more drugs on trial have been designed to attack very specific biological targets. This necessitates the
need to identify, recruit and retain patients that fit an increasingly narrower medical profile. Therefore, pharmaceutical
companies and clinical research organizations are seeking new ways to optimize recruiting operations and gain a
competitive edge
Patient Recruitment and Retention in Clinical Trials is a new report from Business Insights that provides a
comprehensive review of patient recruiting strategies, focusing on successful approaches and emerging trends from
across the globe. Use this report to understand the attitudes affecting patient and physician recruiting in the
U.S, Europe and Japan and identify successful strategies to combat the clinical trials productivity crisis.

Key findings of the report...
• Almost half of all trial delays are caused by patient recruitment
problems. These delays cost makers of specialty products more
than $500,000 in lost sales and they result in losses of over $8m for
blockbusters.
• The Internet is an important tool to recruit both patients and
physicians, but remains under-utilized throughout the US, Europe and
Japan.
• Clinical research continues to migrate from the U.S. and Western
Europe to cheaper offshore locations. Virtually all of the leading
CROs and many pharmaceutical companies including Pfizer, Roche,
GlaxoSmithKline and Novartis now have an established presence in
India, China and Eastern Europe.
• In March 2007, the European Medicines Agency’s (EMEA) adopted a
draft guideline on requirements for first-inman clinical trials for
potential high-risk medicinal products, which could further tighten
patient recruiting.
• In the U.S. and the EU, women continue to be under-represented in
clinical trials, and regulators are yet to penalize drug developers for
under-investigating effects in women.

Key questions answered in this report
• Why are so many clinical trials experiencing patient recruitment
shortfalls?
• What are the financial advantages to improving clinical trial
recruiting?
• Why do most recruiters continue to rely on conventional TV
advertising to reach patients?
• Why does the Internet offer high, but as yet untapped, potential to
recruit both patients and physicians?
• What growing problem is currently faced by clinical trial recruiters in
India?
• Which new segment of the CRO industry is experiencing the
greatest growth?

Top five reasons to order your copy today
• Examine key recruiting trends across the U.S, Europe and Asia and
understand emerging problems facing patient recruitment in India
and China.
• Investigate and benefit from Internet recruiting techniques that
offer untapped potential to recruit both patients and physicians.
• Stay up to date with competitors’ patient and physician
recruiting initiatives and identify what can be incorporated into your
clinical objectives.
• Integrate new recruiting strategies into clinical programs and reduce
product launch delays.
• Assess the applicability of different recruiting strategies to
clinical development programs.


Table of Contents
Table of Contents
Patient Recruitment & Retention in Clinical Trials
Executive Summary 10
Introduction 10
Clinical trial recruitment in the United States 11
Clinical trial recruitment in Europe 12
Clinical trial recruitment in Asia 13
Regional comparison 14
Chapter 1 Introduction 18
Summary 18
The global environment for drug development 19
More sophisticated science 19
More complicated disease targets 21
Heightened regulatory scrutiny 21
Other imperatives requiring greater drug safety 23
Adverse drug reactions 23
DTC Advertising 23
Internet Sourcing of Drugs 25
Rising lawsuits 26
R&D cost pressures 27
Spending on drug development 27
R&D Productivity 28
Outsourced R&D 30
The importance of clinical trial recruitment 31
Growing number and size of clinical trials 31
The cost of patient recruitment delays 32
Emerging recruitment strategies 33
Web-based registries 33
Study-specific websites 35
Specialized publications 36
Proactive targeting measures 36
Conversion and retention 37
Ethical issues 38
Declaration of Helsinki 38
Clinician’s finder fees 39
Participant disclosures 40
Conclusions 41
Chapter 2 Clinical trial recruitment in the US 44
Summary 44
The clinical trial process 45
Contract research 47
Recruitment requirements 48
Recruitment issues 49
Conversion and retention 49
Incentives 50
Regulations 51
Current patient recruitment practices 53
Consumer attitudes towards clinical trials 54
Online recruitment 57
Case study: BBK Worldwide 59
National networks 60
Electronic alerts in computerized medical records 61
Offshore clinical testing 62
New initiatives and best practices 63
Expansion of early testing 64
Including women in clinical trials 64
Usage of prisoners 66
Streamlining of multiple sites 67
Interactive voice response (IVR) 68
Current physician recruitment practices 69
Physician attitudes towards clinical trials 70
Online recruitment 70
Data management 71
Clinical trial information 72
Government sources 72
Other sources 73
Conclusions 74
Chapter 3 Clinical trial recruitment in
Europe 76
Summary 76
The clinical trial process 77
Contract research 80
Eastern Europe 81
CRO developments in Eastern Europe 84
Other parts of Europe 85
Recruitment requirements 85
Recruitment issues 85
Conversion and retention 86
Incentives 87
Regulations 87
Current patient recruitment practices 90
Consumer attitudes towards clinical trials 90
Online recruitment 92
Case study: Richmond Pharmacology 93
New initiatives and best practices 94
Bulgaria and Romania 94
Including women in clinical trials 95
Current physician recruitment practices 96
Physician attitudes towards clinical trials 96
Online recruitment 97
Clinical trial information 97
Government sources 97
Other sources 98
Conclusions 99
Chapter 4 Clinical trial recruitment in Asia 102
Summary 102
The clinical trial process 103
Contract research 104
India 106
Patent issues 109
CRO developments in India 109
China 110
Patent Issues in China 113
CRO developments in China 114
Recruitment requirements 115
Recruitment issues 115
Conversion and retention 115
Incentives 116
Regulations 117
Japan 117
China 118
India 118
Current patient recruitment practices 120
Consumer attitudes towards clinical trials 120
Online recruitment 121
New initiatives and best practices 122
Big pharma clinical trial centers 122
Case study: Shanghai 122
Ethical issues 123
Case study: Chiltern International 124
Current physician recruitment practices 125
Physician attitudes towards clinical trials 125
Online recruitment 126
Clinical trial information 126
Government sources 127
Other sources 127
Conclusions 128
Chapter 5 Regional comparison 130
Summary 130
Consumer attitudes towards clinical trials 131
Demand for access to information 135
Impressions of currently available clinical trial information 136
Physician attitudes towards clinical trials 138
Growth drivers 142
Regional impact on patient recruitment 143
Regional impact on physician recruitment 144
Conclusions 146
Index 148
List of Figures
Figure 1.1: Adverse Drug Events, 1995 - 2006 24
Figure 1.2: NME Approvals vs. R&D Spend (1980 – 2006) 29
Figure 1.3: R&D Spend per NME Approval by Year (1990 – 2005) 30
Figure 3.1: Factors Impacting Study Participation in Europe 91
Figure 4.1: Relative importance of Asian pharmaceutical markets, 2007 103
Figure 4.2: Japanese drug approval process, 2007 105
Figure 5.1: Clinical Study Participation in U.S., EU and Japan, 2005 vs. 2004 131
Figure 5.2: How clinical study participants were enrolled in trials 132
Figure 5.3: Consumers who have looked for health information for themselves or their children
within the past 6 months 133
Figure 5.4: Factors Impacting Patient Study Participation in U.S., EU and Japan 134
Figure 5.5: Consumers who would return regularly to a website that included clinical trial results
135
Figure 5.6: Main obstacles for consumers in accessing clinical trial information online 136
Figure 5.7: Likelihood of returning regularly to a clinical trial website by feature 137
Figure 5.8: Physicians participating in clinical trials, current vs. planned 139
Figure 5.9: How clinical study physicians were enrolled in trials 140
Figure 5.10: Factors Impacting Physician Study Participation in U.S., EU and Japan 141
Figure 5.11: How clinical study physicians were enrolled in trials 144
Figure 5.12: Physician technology utilization in clinical trials by region 145
Figure 5.13: Physician access to technology by region 146
List of Tables
Table 1.1: Recent US drug recalls, 2000 - 2006 22
Table 1.2: US R&D Spend per NME Approved, 1990 - 2005 29
Table 2.3: Patient recruitment requirements by clinical trials phase 49
Table 2.4: US clinical trial recruitment websites 57
Table 2.5: Global operations of leading CROs 63
Table 3.6: Eastern European operations of leading CROs 84
Table 4.7: US FDA new drug application data generated from India 107
Table 5.8: Region-specific growth drivers and restraints for clinical trial activity, 2007 143





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