Patient-Centered Clinical Trials

Sep 4, 2014 - Sep 5, 2014, Boston

Unleash the Potential of Patient-Focused Clinical Research: Redefine Recruitment, Enrollment and Study Management

New Study Insights: What Works Where for Patient Recruitment and Retention Tools and Techniques

Patient recruitment and retention has continued to be one of the largest challenges in clinical development for biopharma companies, with most studies experiencing start-up delays and/or completing late.



There are numerous factors contributing to these delays with those in Figure 1 below being just a few of the most common:

Mitigating these challenges starts with a localized, research-driven approach to deploy targeted recruitment and retention strategies. These approaches are not one size fits all. They are unique, defined by many factors including location, language and cultural relevance. These approaches must also be robust at study start and nimble in response to potential changes throughout the course of any given trial.

In the midst of this complexity, it is critical to maintain focus on the patient as the key stakeholder in the research. One way in which Quintiles maintains this focus is by using the right solutions to provide patients with clear messages, easy access and thorough education as they consider or participate in clinical trials.

In an effort to put this focus into action, Quintiles has developed a two-part global investigation in over 100 countries (illustrated in Figure 2) to confirm “what works where” for patient recruitment and retention tools and techniques.

1. An analysis by country on what tactics are allowed from a legal/regulatory/privacy perspective and culturally acceptable

2. An analysis by investigator preference based on previous experience

 

 

Preliminary analysis shows that, on average, just over 50% of available tools and tactics in Eastern Europe/Middle East are considered both allowed and culturally acceptable, while in Western Europe it is greater than 75%.

 

1.       A Country Examination of Tools and Techniques

Geography and culture play a very important role in determining what tactics are best suited for a particular study. There are a number of nuances to consider when determining the right tool.  Regulatory guidelines broadly define the level of support we can provide sites to recruit and retain patients, however, we must also consider that even if a tactic is allowed, it may not be culturally acceptable among sites and/or patients. 

Further, the approval of tactics can vary across regulatory groups and indications within the same country; one approval does not guarantee or obviate the next.  As such, it is extremely important to have a global strategy that is not only designed to maximize recruitment for the overall study, but also readily customize the recruitment/retention strategy to what is most appropriate within each specific country and site.

In the span of two years, the global approval and acceptance of the evaluated tools and tactics increased by over 20%, with some of the most significant changes seen in the evolving digital space.

In order to generate these and other insights, Quintiles internally evaluated 36 patient recruitment and retention tools and techniques across the globe to help teams determine the best methods for each study that they manage.

The analysis included traditional patient- and site-facing materials (e.g. posters, flyers, brochures, informed consent flip charts, referral tools and templates), advertising (e.g. print, radio, television), digital tools (e.g. internet advertising, email campaigns, patient websites), and retention tools (e.g.study guides, visit schedules, appreciation items,  reminder services, retention communities). Data was captured locally through a number of means including specific regulatory and medical guidance, personal experience, and investigator feedback — each applied as available and necessary. This investigation was completed and compiled in July and August 2014 and compares against a previous investigation in 2012. 

2.       The Voice of the Investigator

The role of investigators cannot be understated in today’s current clinical development environment. We rely upon investigators to ultimately screen, enroll, and retain patients inthe studies that we conduct. They are the experts on what works at their particular site or practice so their perspective is critical to success. Just as individual countries differ in what approach works for them, there can also be significant variability from site to site within a single country. It is the combination of investigator knowledge and their ability to apply those techniques that are broadly acceptable in their countries that allows us to maximize potential enrollment.

For this reason, Quintiles also surveyed and received responses from more than 9,400 investigators across more than 95 countries to understand their needs, experiences, and preferences across these same tools and techniques.  See Figure 3.

 

 

A few of the interesting outcomes from this investigation are:

 

  • To recruit patients within their own site, 59% of investigators from US and Canada indicate they have found poster/flyers most effective, while patient education materials were mentioned most often (32% - 41%) in all other regions. By understanding the nuances across the regions, we can ensure that investigators are able to communicate as effectively as possible with their current patients.

 

  • 57% of investigators in the US and Canada indicated that advertising has been the most effective way to recruit patients outside of their practice, while all other regions indicated physician referrals as the top method (51% - 54%). While these results could be an indicator of the type of medium patients are most compelled by, it also coincides closely to the percentage of investigators that feel they have adequate patients at their own sites and do not require external recruitment.

Patient recruitment and retention is a key part when a CRO is leveraging experience, tools and processes to optimize study start-up.  Supported by this latest data, Quintiles is confident that they’ll employ the right patient recruitment and retention techniques to each study, and apply them strategically to help customers improve their probability of success. Those insights thus help to ensure that patients know about their available options for participating in clinical trials as part of their care.


About the Authors: Chris Frega, Sr. Director, Quintiles, oversees the global feasibility and patient recruitment functions.

 

Stacy Whaley, MBA, Associate Director, Quintiles, manages functions that support global patient recruitment and retention

 

Interested in hearing more?

More detail on these investigations, the key insights drawn from them, and how they are being applied will be presented at the Patient-Centered Clinical Trials conference on September 4-5, 2014,  and will be featured in an upcoming white paper.


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Patient-Centered Clinical Trials

Sep 4, 2014 - Sep 5, 2014, Boston

Unleash the Potential of Patient-Focused Clinical Research: Redefine Recruitment, Enrollment and Study Management

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