Clinical Trial Recruitment Strategies

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


The recruitment of patients for clinical trials is an important component of the complex and inherently risky R&ampD approach for pharmaceuticals. ( ) Operationally, patient recruitment includes targeting the right patients with the right messages and retaining enrolled patients with powerful ‘customer service’. Nonetheless, patient recruitment also impacts on crucial strategic objectives involving the arranging of trial protocols and the management of risk.


1 of most considerable challenges connected with clinical trial recruitment is managing the relationships amongst the different partners who each and every play an essential function in recruiting and retaining patients.

It is not unusual for late stage clinical trial recruitment to involve a partnership in between the trial sponsor, a devoted contract analysis organization, a patient recruitment agency, a communications agency and clinical investigators at the trial websites themselves. A important amount of organizing and coordination is required to bring each and every party together and deliver on their respective objectives.


As a result of the important importance of patient recruitment, and the inherent complexity of dealing with agency and clinical partners, as effectively as managing the expectations of patients, it has turn into a distinct location of prospective competitive advantage. In the exact same way that alliance management or sales force deployment have helped some organizations to develop competitive advantages, these businesses greatest able to deliver on their patient recruitment and retention objectives will enjoy a comparative benefit in late stage clinical trial delivery, completing trials with higher levels of expense-efficiency, timeliness and achievement.


Crucial functions of this report


• Evaluation of patient recruitment: a detailed analysis as to the critical function played by patient recruitment within the broader clinical trial program and beyond


• Contextual trend analysis: a complete trend evaluation setting the context for patient recruitment efforts across the varying parameters connected with clinical trials


• Crucial efficiency 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 total value of successful patient recruitment as an crucial component of the wider clinical trial function


• Establish a contextual framework for patient recruitment arranging and program management based on the newest trends in trial style and patient recruitment performance


• Set beneficial overall performance benchmarks to guide recruitment efforts and identify the essential drivers of benchmarked results in order to keep recruitment projects on track


Essential Marketplace Concerns


(1) Competitors for patients

The number and average size of late stage clinical trials has increase significantly more than the last five years, resulting in a significant improve in the competition to recruit patients


(2) Trial internet site choice

As the competition for patients has increased, the average number of trial sites employed for every single trial has also elevated, putting extended pressure on the essential selection of website selection


(three) Protocol design and inclusion/exclusion criteria

The effect of patient recruitment preparing on the style of trial protocols and eventual inclusion/exclusion criteria is leading to a a lot more clear incorporation of the ‘recruitability’ measure for patients when designing trials


Crucial findings from this report


(1) In the exact same way that alliance management or sales force deployment have helped some firms to create competitive advantages, those businesses greatest able to deliver on their patient recruitment and retention objectives will take pleasure in a comparative advantage in late stage clinical trial delivery, completing trials with greater levels of expense-efficiency, timeliness and success. (chapter 1)


(2) Although trial lifecycles seem to be shortening, the rate of productive completion for late stage trials is also falling. Patient enrollment levels are rising, which in turn has led to a important rise in the average number of trial sites involved in each trial. The requirement to boost trial recruitment numbers is compounded by an improve in inclusion/exclusion criteria which narrows the field of possible trial candidates. (chapter two)


(three) Global trial programs have the longest typical recruitment window, regardless of getting the lowest recruitment period per enrollee amongst other trial places. Phase III trials conducted outdoors North America are connected with the longest recruitment and relative recruitment periods. International trial programs are connected with the longest completion delays, while European trials outcome in the longest delays relative to the number of enrollees. (chapter three)


Essential questions answered


• How critical is patient recruitment inside the context of the clinical trial method and its function in the overall results in the pharmaceutical market?


• What are the important trends in the quantity, length, completion failure rate and size of clinical trials and how do these trends influence on patient recruitment?


• What are the important benchmarks tracking the performance of not too long ago completed trials by length of recruitment and any subequent delay?


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