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Clinical Trial Recruitment Strategies: Optimizing Patient Recruitment and Retention in Late Stage Clinical Trials

Description:
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

- 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

- 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

- 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

- 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)

- 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)

- 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 subsequent delay?
 
Contents:
Clinical trial recruitment strategies
Executive Summary
An introduction to patient recruitment in late stage clinical trials
Trends in clinical trials and patient recruitment
Patient recruitment performance benchmarks
Best practices in patient recruitment
Critical success factors for effective patient recruitment

Chapter 1 An introduction to patient recruitment in late stage clinical trials
Summary
Introduction
Defining patient recruitment strategy
The importance of effective patient recruitment
Cost-effective R&D
Getting to market quickly
Limiting trial failure
Report outline
Trends in clinical trials and patient recruitment
Patient recruitment performance benchmarks
Best practices in patient recruitment
Critical success factors for effective patient recruitment

Chapter 2 Trends in clinical trials and patient recruitment
Summary
Introduction
The late stage clinical trial landscape
Number of competing clinical trials
Trends by trial phase
Trends by location
Trends by therapeutic category
Trends by source of funding
Length of clinical trials
Trends by trial phase
Trends by location
Trends by therapeutic category
Trends by source of funding
Successful completion of clinical trials
Trends by trial phase
Trends by location
Trends by therapeutic category
Trends by source of funding
Size of clinical trials
Trends by trial phase
Trends by location
Trends by therapeutic category
Trends by source of funding
Number of trial sites involved in clinical trials
Trends by trial phase
Trends by location
Trends by therapeutic category
Trends by source of funding
Inclusion/exclusion criteria involved in clinical trials
Trends by trial phase
Trends by location
Trends by therapeutic category
Trends by source of funding
Impact on patient recruitment

Chapter 3 Patient recruitment performance benchmarks
Summary
Introduction
Key performance measures
Length of recruitment period
Size of delay
Recruitment period
Trends by trial phase
Trends by location
Trends by therapeutic category
Trends by source of funding
Trends by size of trial
Trends by trial sites
Trends by inclusion/exclusion criteria
Delay
Trends by trial phase
Trends by location
Trends by therapeutic category
Trends by source of funding
Trends by size of trial
Trends by trial sites
Trends by inclusion/exclusion criteria
Summary of patient recruitment performance
Project management for patient recruitment

Chapter 4 Best practices in patient recruitment
Summary
Introduction
Planning for patient recruitment strategies
Challenges
Timing
Modeling
Case study: Recruitment modeling at GSK
Inputs
Responsibilities
Competition
Implementation of the recruitment process
Challenges
Relationships
Communication
Awareness
Enrollment
Case study: Healthcare Communications Group
Managing patient recruitment issues and challenges
Challenges
Retention and compliance
Case study: Exco InTouch
Responding to problems
Monitoring and sanctions

Chapter 5 Critical success factors for effective patient recruitment
Summary
Introduction
Key challenges
Key success factors
Choosing the right target patients
Designing the right trial protocol and inclusion/exclusion criteria
Selecting the most appropriate sites and investigators
Ensuring communications strategy drives patient awareness and conversion
Monitoring trial recruitment progress and responding to problems
Key recommendations
Understand the importance of patient recruitment
Understand the context and apply appropriate benchmarks
Understand the major challenges
Apply key success factors
Get help where needed
Experience and learn

Chapter 6 Appendix
Delphi Pharma’s Clinical Trials Database
Primary research
Secondary research
Index

List of Figures

Figure 1.1: The rising cost of new drug development, 1975-2006
Figure 1.2: Impact of US patent expiries for leading drugs, 2008-2013
Figure 1.3: R&D productivity levels in the US, 1999-2008
Figure 2.4: Key trends in the number of competing clinical trials, 2005-2009
Figure 2.5: Trends in the distribution of competing clinical trials by trial Phase, 2005-2009
Figure 2.6: Trends in the distribution of competing clinical trials by site location, 2005-2009
Figure 2.7: Trends in the distribution of Phase III trials by site location, 2005-2009
Figure 2.8: Trends in the distribution of competing clinical trials by therapeutic category, 2005- 2009
Figure 2.9: Trends in the distribution of Phase III trials by therapeutic category, 2005-2009
Figure 2.10: Trends in the distribution of competing clinical trials by source of funding, 2005-2
Figure 2.11: Trends in the distribution of Phase III trials by source of funding, 2005-2009
Figure 2.12: Key trends in the average length of clinical trials, 2005-2009
Figure 2.13: Trends in the average length of clinical trials by trial phase, 2005-2009
Figure 2.14: Trends in the average length of clinical trials by site location, 2005-2009
Figure 2.15: Trends in the average length of Phase III trials by site location, 2005-2009
Figure 2.16: Trends in the average length of clinical trials by therapeutic category, 2005-2009
Figure 2.17: Trends in the average length of Phase III trials by therapeutic category, 2005-2009
Figure 2.18: Trends in the average length of clinical trials by source of funding, 2005-2009
Figure 2.19: Trends in the average length of Phase III trials by source of funding, 2005-2009
Figure 2.20: Key trends in the average failure rate for clinical trials, 2005-2009
Figure 2.21: Trends in the average failure rate for clinical trials by trial phase, 2005-2009
Figure 2.22: Trends in the average failure rate for clinical trials by site location, 2005-2009
Figure 2.23: Trends in the average failure rate for Phase III trials by site location, 2005-2009
Figure 2.24: Trends in the average failure rate for clinical trials by therapeutic category, 2005-2009
Figure 2.25: Trends in the average failure rate for Phase III trials by therapeutic category, 2005- 2009
Figure 2.26: Trends in the average failure rate for clinical trials by source of funding, 2005-2009
Figure 2.27: Trends in the average failure rate for Phase III trials by source of funding, 2005-2009
Figure 2.28: Key trends in the average enrollment for clinical trials, 2005-2009
Figure 2.29: Trends in the average enrollment for clinical trials by trial phase, 2005-2009
Figure 2.30: Trends in the average enrollment for clinical trials by site location, 2005-2009
Figure 2.31: Trends in the average enrollment for Phase III trials by site location, 2005-2009
Figure 2.32: Trends in the average enrollment for clinical trials by therapeutic category, 2005-2009
Figure 2.33: Trends in the average enrollment for Phase III trials by therapeutic category, 2005- 2009
Figure 2.34: Trends in the average enrollment for clinical trials by source of funding, 2005-2009
Figure 2.35: Trends in the average enrollment for Phase III trials by source of funding, 2005-2009
Figure 2.36: Key trends in the average number of trial sites for clinical trials, 2005-2009
Figure 2.37: Trends in the average number of trial sites for clinical trials by trial phase, 2005-2009
Figure 2.38: Trends in the average number of trial sites for clinical trials by site location, 2005- 2009
Figure 2.39: Trends in the average number of trial sites for Phase III trials by site location, 2005- 2009
Figure 2.40: Trends in the average number of trial sites for clinical trials by therapeutic category, 2005-2009
Figure 2.41: Trends in the average number of trial sites for Phase III trials by therapeutic category, 2005-2009
Figure 2.42: Trends in the average number of trial sites for clinical trials by source of funding, 2005-2009
Figure 2.43: Trends in the average number of trial sites for Phase III trials by source of funding, 2005-2009
Figure 2.44: Key trends in the average number of inclusion/exclusion criteria for clinical trials, 2005-2009
Figure 2.45: Trends in the average number of inclusion/exclusion criteria for clinical trials by trial phase, 2005-2009
Figure 2.46: Trends in the average number of inclusion/exclusion criteria for clinical trials by site location, 2005-2009
Figure 2.47: Trends in the average number of inclusion/exclusion criteria for Phase III trials by site location, 2005-2009
Figure 2.48: Trends in the average number of inclusion/exclusion criteria for clinical trials bytherapeutic category, 2005-2009
Figure 2.49: Trends in the average number of inclusion/exclusion criteria for Phase III trials by therapeutic category, 2005-2009
Figure 2.50: Trends in the average number of inclusion/exclusion criteria for clinical trials by source of funding, 2005-2009
Figure 2.51: Trends in the average number of inclusion/exclusion criteria for Phase III trials by source of funding, 2005-2009
Figure 3.52: Distribution of clinical trials by length of recruitment period, 2009
Figure 3.53: Distribution of clinical trials by relative length of recruitment per enrollee, 2009
Figure 3.54: Distribution of clinical trials by length of delay, 2009
Figure 3.55: Distribution of clinical trials by relative length of delay per enrollee, 2009
Figure 3.56: Distribution of clinical trials by relative rate of delay, 2009
Figure 3.57: Key trends in the average recruitment period for clinical trials, 2009
Figure 3.58: Trends in the average recruitment period for clinical trials by trial phase, 2009
Figure 3.59: Trends in the average recruitment period for clinical trials by site location, 2009
Figure 3.60: Trends in the average recruitment period for Phase III trials by site location, 2009
Figure 3.61: Trends in the average recruitment period for clinical trials by therapeutic category, 2009
Figure 3.62: Trends in the average recruitment period for Phase III trials by therapeutic category, 2009
Figure 3.63: Trends in the average recruitment period for clinical trials by source of funding, 2009
Figure 3.64: Trends in the average recruitment period for Phase III trials by source of funding, 2009
Figure 3.65: Key trends in the average delay for clinical trials, 2009
Figure 3.66: Trends in the average delay for clinical trials by trial phase, 2009
Figure 3.67: Trends in the average delay for clinical trials by site location, 2009
Figure 3.68: Trends in the average delay for Phase III trials by site location, 2009
Figure 3.69: Trends in the average delay for clinical trials by therapeutic category, 2009
Figure 3.70: Trends in the average delay for Phase III trials by therapeutic category, 2009
Figure 3.71: Trends in the average delay for clinical trials by source of funding, 2009
Figure 3.72: Trends in the average delay for Phase III trials by source of funding, 2009
Figure 3.73: Patient recruitment trade-off between cost, time and scope

List of Tables

Table 2.1: Key trends in the number of competing clinical trials, 2005-2009
Table 2.2: Key trends in the distribution of clinical trials, 2005-2009
Table 2.3: Key trends in the distribution of Phase III trials, 2005-2009
Table 2.4: Key trends in the average length of clinical trials, 2005-2009
Table 2.5: Key trends in the average length of Phase III trials, 2005-2009
Table 2.6: Key trends in the average failure rate for clinical trials, 2005-2009
Table 2.7: Key trends in the average failure rate for Phase III trials, 2005-2009
Table 2.8: Key trends in the average enrollment for clinical trials, 2005-2009
Table 2.9: Key trends in the average enrollment for Phase III trials, 2005-2009
Table 2.10: Key trends in the average number of trial sites for clinical trials, 2005-2009
Table 2.11: Key trends in the average number of trial sites for Phase III trials, 2005-2009
Table 2.12: Key trends in the average number of inclusion/exclusion criteria for clinical trials, 2005-2009
Table 2.13: Key trends in the average number of inclusion/exclusion criteria for Phase III trials, 2005-2009
Table 3.14: Key trends in the average recruitment period for clinical trials, 2009
Table 3.15: Key trends in the average recruitment period for Phase III trials, 2009
Table 3.16: Trends in the average recruitment period for clinical trials by size of trial, 2009
Table 3.17: Trends in the average recruitment period for Phase III trials by size of trial, 2009
Table 3.18: Trends in the average recruitment period for clinical trials by number of trial sites, 2009
Table 3.19: Trends in the average recruitment period for Phase III trials by number of trial sites, 2009
Table 3.20: Trends in the average recruitment period for clinical trials by number of inclusion/exclusion criteria, 2009
Table 3.21: Trends in the average recruitment period for Phase III trials by number of inclusion/exclusion criteria, 2009
Table 3.22: Key trends in the average delay for clinical trials, 2009
Table 3.23: Key trends in the average delay for Phase III trials, 2009
Table 3.24: Trends in the average delay for clinical trials by size of trial, 2009
Table 3.25: Trends in the average delay for Phase III trials by size of trial, 2009
Table 3.26: Trends in the average delay for clinical trials by number of trial sites, 2009
Table 3.27: Trends in the average delay for Phase III trials by number of trial sites, 2009
Table 3.28: Trends in the average delay for clinical trials by number of inclusion/exclusion criteria, 2009
Table 3.29: Trends in the average delay for Phase III trials by number of inclusion/exclusion criteria, 2009
 
Companies Mentioned
- Exco InTouch
- GSK
- Healthcare Communications Group
 
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