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:
* 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?
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