Clinical Trial Recruitment Strategies: Optimizing patient recruitment and retention in late stage clinical trials

Date: January 22, 2010
Pages: 171
Price:
US$ 3,835.00
Publisher: Business Insights
Report type: Strategic Report
Delivery: E-mail Delivery (PDF), Hard Copy Mail Delivery, CD-ROM Mail Delivery
ID: C5E66237247EN
Leaflet:

Download PDF Leaflet

Clinical Trial Recruitment Strategies: Optimizing patient recruitment and retention in late stage clinical trials
The recruitment of patients for clinical trials is an essential part of the complex and inherently risky R&D process for pharmaceuticals. Operationally, patient recruitment involves targeting the right patients with the right messages and retaining enrolled patients with effective ‘customer service’. However, patient recruitment also impacts on crucial strategic objectives involving the planning of trial protocols and the management of risk.

One of most significant challenges associated with clinical trial recruitment is managing the relationships between the different partners who each play an essential role in recruiting and retaining patients. It is not unusual for late stage clinical trial recruitment to involve a partnership between the trial sponsor, a dedicated contract research organization, a patient recruitment agency, a communications agency and clinical investigators at the trial sites themselves. A significant amount of planning and coordination is required to bring each party together and deliver on their respective objectives.

As a result of the critical importance of patient recruitment, and the inherent complexity of dealing with agency and clinical partners, as well as managing the expectations of patients, it has become a distinct area of potential competitive advantage. In the same way that alliance management or sales force deployment have helped some companies to develop competitive advantages, those companies best able to deliver on their patient recruitment and retention objectives will enjoy a comparative advantage in late stage clinical trial delivery, completing trials with greater levels of cost-efficiency, timeliness and success.

Key features of this report

  • Evaluation of patient recruitment: a detailed analysis as to the important role played by patient recruitment within the broader clinical trial program and beyond
  • Contextual trend analysis: a comprehensive trend analysis setting the context for patient recruitment efforts across the varying parameters associated with clinical trials
  • Key performance benchmarks: a detailed set of patient recruitment benchmark targets based on the most up to date clinical trial data available


  • Scope of this report

  • Understand and communicate the full value of effective patient recruitment as an essential part of the wider clinical trial function
  • Establish a contextual framework for patient recruitment planning and program management based on the latest trends in trial design and patient recruitment performance
  • Set useful performance benchmarks to guide recruitment efforts and identify the key drivers of benchmarked success in order to keep recruitment projects on track


  • Key Market Issues

    (1) Competition for patients
    The number and average size of late stage clinical trials has increase significantly over the last 5 years, resulting in a significant increase in the competition to recruit patients

    (2) Trial site selection
    As the competition for patients has increased, the average number of trial sites used for each trial has also increased, putting extended pressure on the important decision of site selection

    (3) Protocol design and inclusion/exclusion criteria
    The impact of patient recruitment planning on the design of trial protocols and eventual inclusion/exclusion criteria is leading to a more clear incorporation of the ‘recruitability’ measure for patients when designing trials

    Key findings from this report

    (1) In the same way that alliance management or sales force deployment have helped some companies to develop competitive advantages, those companies best able to deliver on their patient recruitment and retention objectives will enjoy a comparative advantage in late stage clinical trial delivery, completing trials with greater levels of cost-efficiency, timeliness and success. (chapter 1)
    (2) Although trial lifecycles appear to be shortening, the rate of successful completion for late stage trials is also falling. Patient enrollment levels are increasing, which in turn has led to a significant rise in the average number of trial sites involved in each trial. The requirement to increase trial recruitment numbers is compounded by an increase in inclusion/exclusion criteria which narrows the field of potential trial candidates. (chapter 2)
    (3) Global trial programs have the longest average recruitment window, despite having the lowest recruitment period per enrollee amongst other trial locations. Phase III trials conducted outside North America are associated with the longest recruitment and relative recruitment periods. Global trial programs are associated with the longest completion delays, while European trials result in the longest delays relative to the number of enrollees. (chapter 3)

    Key questions answered


  • How important is patient recruitment within the context of the clinical trial process and its role in the overall success in the pharmaceutical industry?
  • What are the key trends in the number, length, completion failure rate and size of clinical trials and how do these trends impact on patient recruitment?
  • What are the key benchmarks tracking the performance of recently completed trials by length of recruitment and any subequent delay?


  • Clinical trial recruitment strategies
    Executive Summary 12
    An introduction to patient recruitment in late stage clinical trials 12
    Trends in clinical trials and patient recruitment 13
    Patient recruitment performance benchmarks 14
    Best practices in patient recruitment 15
    Critical success factors for effective patient recruitment 16

    CHAPTER 1 AN INTRODUCTION TO PATIENT RECRUITMENT IN LATE STAGE CLINICAL TRIALS

    Summary 18
    Introduction 19
    Defining patient recruitment strategy 20
    The importance of effective patient recruitment 21
    Cost-effective R&D 21
    Getting to market quickly 22
    Limiting trial failure 23
    Report outline 25
    Trends in clinical trials and patient recruitment 25
    Patient recruitment performance benchmarks 25
    Best practices in patient recruitment 26
    Critical success factors for effective patient recruitment 26

    CHAPTER 2 TRENDS IN CLINICAL TRIALS AND PATIENT RECRUITMENT

    Summary 28
    Introduction 29
    The late stage clinical trial landscape 29
    Number of competing clinical trials 31
    Trends by trial phase 33
    Trends by location 36
    Trends by therapeutic category 38
    Trends by source of funding 40
    Length of clinical trials 41
    Trends by trial phase 44
    Trends by location 46
    Trends by therapeutic category 48
    Trends by source of funding 50
    Successful completion of clinical trials 51
    Trends by trial phase 54
    Trends by location 56
    Trends by therapeutic category 58
    Trends by source of funding 60
    Size of clinical trials 61
    Trends by trial phase 64
    Trends by location 66
    Trends by therapeutic category 68
    Trends by source of funding 70
    Number of trial sites involved in clinical trials 71
    Trends by trial phase 74
    Trends by location 76
    Trends by therapeutic category 78
    Trends by source of funding 80
    Inclusion/exclusion criteria involved in clinical trials 82
    Trends by trial phase 85
    Trends by location 87
    Trends by therapeutic category 89
    Trends by source of funding 91
    Impact on patient recruitment 92

    CHAPTER 3 PATIENT RECRUITMENT PERFORMANCE BENCHMARKS

    Summary 96
    Introduction 97
    Key performance measures 97
    Length of recruitment period 98
    Size of delay 100
    Recruitment period 103
    Trends by trial phase 105
    Trends by location 108
    Trends by therapeutic category 110
    Trends by source of funding 112
    Trends by size of trial 114
    Trends by trial sites 114
    Trends by inclusion/exclusion criteria 116
    Delay 118
    Trends by trial phase 120
    Trends by location 122
    Trends by therapeutic category 123
    Trends by source of funding 126
    Trends by size of trial 128
    Trends by trial sites 129
    Trends by inclusion/exclusion criteria 130
    Summary of patient recruitment performance 131
    Project management for patient recruitment 133

    CHAPTER 4 BEST PRACTICES IN PATIENT RECRUITMENT

    Summary 136
    Introduction 137
    Planning for patient recruitment strategies 137
    Challenges 137
    Timing 139
    Modeling 140
    Case study: Recruitment modeling at GSK 141
    Inputs 142
    Responsibilities 142
    Competition 143
    Implementation of the recruitment process 144
    Challenges 144
    Relationships 145
    Communication 145
    Awareness 146
    Enrollment 146
    Case study: Healthcare Communications Group 147
    Managing patient recruitment issues and challenges 148
    Challenges 148
    Retention and compliance 149
    Case study: Exco InTouch 150
    Responding to problems 150
    Monitoring and sanctions 151

    CHAPTER 5 CRITICAL SUCCESS FACTORS FOR EFFECTIVE PATIENT RECRUITMENT

    Summary 154
    Introduction 155
    Key challenges 155
    Key success factors 156
    Choosing the right target patients 157
    Designing the right trial protocol and inclusion/exclusion criteria 158
    Selecting the most appropriate sites and investigators 158
    Ensuring communications strategy drives patient awareness and conversion 159
    Monitoring trial recruitment progress and responding to problems 159
    Key recommendations 160
    Understand the importance of patient recruitment 160
    Understand the context and apply appropriate benchmarks 161
    Understand the major challenges 161
    Apply key success factors 162
    Get help where needed 162
    Experience and learn 163

    CHAPTER 6 APPENDIX

    Delphi Pharma’s Clinical Trials Database 166
    Primary research 169
    Secondary research 170
    Index 171

    LIST OF FIGURES

    Figure 1.1: The rising cost of new drug development, 1975-2006 22
    Figure 1.2: Impact of US patent expiries for leading drugs, 2008-2013 23
    Figure 1.3: R&D productivity levels in the US, 1999-2008 24
    Figure 2.4: Key trends in the number of competing clinical trials, 2005-2009 33
    Figure 2.5: Trends in the distribution of competing clinical trials by trial Phase, 2005-2009 34
    Figure 2.6: Trends in the distribution of competing clinical trials by site location, 2005-2009 36
    Figure 2.7: Trends in the distribution of Phase III trials by site location, 2005-2009 37
    Figure 2.8: Trends in the distribution of competing clinical trials by therapeutic category, 2005- 2009 38
    Figure 2.9: Trends in the distribution of Phase III trials by therapeutic category, 2005-2009 39
    Figure 2.10: Trends in the distribution of competing clinical trials by source of funding, 2005-2009
    Figure 2.11: Trends in the distribution of Phase III trials by source of funding, 2005-2009 41
    Figure 2.12: Key trends in the average length of clinical trials, 2005-2009 43
    Figure 2.13: Trends in the average length of clinical trials by trial phase, 2005-2009 44
    Figure 2.14: Trends in the average length of clinical trials by site location, 2005-2009 46
    Figure 2.15: Trends in the average length of Phase III trials by site location, 2005-2009 47
    Figure 2.16: Trends in the average length of clinical trials by therapeutic category, 2005-2009 48
    Figure 2.17: Trends in the average length of Phase III trials by therapeutic category, 2005-2009 49
    Figure 2.18: Trends in the average length of clinical trials by source of funding, 2005-2009 50
    Figure 2.19: Trends in the average length of Phase III trials by source of funding, 2005-2009 51
    Figure 2.20: Key trends in the average failure rate for clinical trials, 2005-2009 53
    Figure 2.21: Trends in the average failure rate for clinical trials by trial phase, 2005-2009 54
    Figure 2.22: Trends in the average failure rate for clinical trials by site location, 2005-2009 56
    Figure 2.23: Trends in the average failure rate for Phase III trials by site location, 2005-2009 57
    Figure 2.24: Trends in the average failure rate for clinical trials by therapeutic category, 2005-2009 58
    Figure 2.25: Trends in the average failure rate for Phase III trials by therapeutic category, 2005- 2009 59
    Figure 2.26: Trends in the average failure rate for clinical trials by source of funding, 2005-2009 60
    Figure 2.27: Trends in the average failure rate for Phase III trials by source of funding, 2005-2009 61
    Figure 2.28: Key trends in the average enrollment for clinical trials, 2005-2009 63
    Figure 2.29: Trends in the average enrollment for clinical trials by trial phase, 2005-2009 64
    Figure 2.30: Trends in the average enrollment for clinical trials by site location, 2005-2009 66
    Figure 2.31: Trends in the average enrollment for Phase III trials by site location, 2005-2009 67
    Figure 2.32: Trends in the average enrollment for clinical trials by therapeutic category, 2005-2009 68
    Figure 2.33: Trends in the average enrollment for Phase III trials by therapeutic category, 2005- 2009 69
    Figure 2.34: Trends in the average enrollment for clinical trials by source of funding, 2005-2009 70
    Figure 2.35: Trends in the average enrollment for Phase III trials by source of funding, 2005-2009 71
    Figure 2.36: Key trends in the average number of trial sites for clinical trials, 2005-2009 73
    Figure 2.37: Trends in the average number of trial sites for clinical trials by trial phase, 2005-2009 74
    Figure 2.38: Trends in the average number of trial sites for clinical trials by site location, 2005- 2009 76
    Figure 2.39: Trends in the average number of trial sites for Phase III trials by site location, 2005- 2009 77
    Figure 2.40: Trends in the average number of trial sites for clinical trials by therapeutic category, 2005-2009 78
    Figure 2.41: Trends in the average number of trial sites for Phase III trials by therapeutic category, 2005-2009 79
    Figure 2.42: Trends in the average number of trial sites for clinical trials by source of funding, 2005-2009 80
    Figure 2.43: Trends in the average number of trial sites for Phase III trials by source of funding, 2005-2009 81
    Figure 2.44: Key trends in the average number of inclusion/exclusion criteria for clinical trials, 2005-2009 84
    Figure 2.45: Trends in the average number of inclusion/exclusion criteria for clinical trials by trial phase, 2005-2009 85
    Figure 2.46: Trends in the average number of inclusion/exclusion criteria for clinical trials by site location, 2005-2009 87
    Figure 2.47: Trends in the average number of inclusion/exclusion criteria for Phase III trials by site location, 2005-2009 88
    Figure 2.48: Trends in the average number of inclusion/exclusion criteria for clinical trials bytherapeutic category, 2005-2009 89
    Figure 2.49: Trends in the average number of inclusion/exclusion criteria for Phase III trials by therapeutic category, 2005-2009 90
    Figure 2.50: Trends in the average number of inclusion/exclusion criteria for clinical trials by source of funding, 2005-2009 91
    Figure 2.51: Trends in the average number of inclusion/exclusion criteria for Phase III trials by source of funding, 2005-2009 92
    Figure 3.52: Distribution of clinical trials by length of recruitment period, 2009 99
    Figure 3.53: Distribution of clinical trials by relative length of recruitment per enrollee, 2009 100
    Figure 3.54: Distribution of clinical trials by length of delay, 2009 101
    Figure 3.55: Distribution of clinical trials by relative length of delay per enrollee, 2009 102
    Figure 3.56: Distribution of clinical trials by relative rate of delay, 2009 103
    Figure 3.57: Key trends in the average recruitment period for clinical trials, 2009 105
    Figure 3.58: Trends in the average recruitment period for clinical trials by trial phase, 2009 106
    Figure 3.59: Trends in the average recruitment period for clinical trials by site location, 2009 108
    Figure 3.60: Trends in the average recruitment period for Phase III trials by site location, 2009 109
    Figure 3.61: Trends in the average recruitment period for clinical trials by therapeutic category, 2009 110
    Figure 3.62: Trends in the average recruitment period for Phase III trials by therapeutic category, 2009 111
    Figure 3.63: Trends in the average recruitment period for clinical trials by source of funding, 2009 112
    Figure 3.64: Trends in the average recruitment period for Phase III trials by source of funding, 2009 113
    Figure 3.65: Key trends in the average delay for clinical trials, 2009 119
    Figure 3.66: Trends in the average delay for clinical trials by trial phase, 2009 120
    Figure 3.67: Trends in the average delay for clinical trials by site location, 2009 122
    Figure 3.68: Trends in the average delay for Phase III trials by site location, 2009 123
    Figure 3.69: Trends in the average delay for clinical trials by therapeutic category, 2009 124
    Figure 3.70: Trends in the average delay for Phase III trials by therapeutic category, 2009 125
    Figure 3.71: Trends in the average delay for clinical trials by source of funding, 2009 126
    Figure 3.72: Trends in the average delay for Phase III trials by source of funding, 2009 127
    Figure 3.73: Patient recruitment trade-off between cost, time and scope 134

    LIST OF TABLES

    Table 2.1: Key trends in the number of competing clinical trials, 2005-2009 31
    Table 2.2: Key trends in the distribution of clinical trials, 2005-2009 32
    Table 2.3: Key trends in the distribution of Phase III trials, 2005-2009 35
    Table 2.4: Key trends in the average length of clinical trials, 2005-2009 42
    Table 2.5: Key trends in the average length of Phase III trials, 2005-2009 45
    Table 2.6: Key trends in the average failure rate for clinical trials, 2005-2009 52
    Table 2.7: Key trends in the average failure rate for Phase III trials, 2005-2009 55
    Table 2.8: Key trends in the average enrollment for clinical trials, 2005-2009 62
    Table 2.9: Key trends in the average enrollment for Phase III trials, 2005-2009 65
    Table 2.10: Key trends in the average number of trial sites for clinical trials, 2005-2009 72
    Table 2.11: Key trends in the average number of trial sites for Phase III trials, 2005-2009 75
    Table 2.12: Key trends in the average number of inclusion/exclusion criteria for clinical trials, 2005-2009 83
    Table 2.13: Key trends in the average number of inclusion/exclusion criteria for Phase III trials, 2005-2009 86
    Table 3.14: Key trends in the average recruitment period for clinical trials, 2009 104
    Table 3.15: Key trends in the average recruitment period for Phase III trials, 2009 107
    Table 3.16: Trends in the average recruitment period for clinical trials by size of trial, 2009 114
    Table 3.17: Trends in the average recruitment period for Phase III trials by size of trial, 2009 114
    Table 3.18: Trends in the average recruitment period for clinical trials by number of trial sites, 2009 115
    Table 3.19: Trends in the average recruitment period for Phase III trials by number of trial sites, 2009 115
    Table 3.20: Trends in the average recruitment period for clinical trials by number of inclusion/exclusion criteria, 2009 116
    Table 3.21: Trends in the average recruitment period for Phase III trials by number of inclusion/exclusion criteria, 2009 117
    Table 3.22: Key trends in the average delay for clinical trials, 2009 118
    Table 3.23: Key trends in the average delay for Phase III trials, 2009 121
    Table 3.24: Trends in the average delay for clinical trials by size of trial, 2009 128
    Table 3.25: Trends in the average delay for Phase III trials by size of trial, 2009 128
    Table 3.26: Trends in the average delay for clinical trials by number of trial sites, 2009 129
    Table 3.27: Trends in the average delay for Phase III trials by number of trial sites, 2009 129
    Table 3.28: Trends in the average delay for clinical trials by number of inclusion/exclusion criteria, 2009 130
    Table 3.29: Trends in the average delay for Phase III trials by number of inclusion/exclusion criteria, 2009 130

    Skip to top


    Ask Your Question

    Clinical Trial Recruitment Strategies: Optimizing patient recruitment and retention in late stage clinical trials
    Company name*:
    Contact person*:
    Phone/fax*:
    Email*:
    Request invoice
    Your enquiry:
    Please click on a Check Box below to confirm you are not a robot: