Clinical Trial Recruitment Strategies

Optimizing patient recruitment and retention in late stage clinical trials

Product Code RBI00384
Publication Date January 2010
Publisher Business Insights
Product Type Report
Pages 171
ISBN Number not applicable
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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

  1. 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

  1. 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?

Contents

  • 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 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, 2005-200
    • 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