December 2, 2014 | Clinical research associates (CRAs) serve as the primary contact point between sites and sponsors, but should this access and position also lead them to be site recruitment managers?  

That’s the question posed to the members of a panel to be held at the Summit for Clinical Ops Executives—SCOPE—in February in Orlando*.  

 

Beth Harper, President, Consultant, CPP; Nikki Christison, President, Consultant, Clinical Resolutions; and Gretchen Goller, Senior Director, Patient Access and Retention Services, PRA International will discuss how the industry views the role of site recruitment manager and what tools CRAs might need to do the job. 

 

Over the holiday weekend Harper, Christison, and Goller gave Clinical Informatics News a preview of their positions. 

 

Clinical Informatics News: The three of you are running a panel in February at SCOPE focusing on whether CRAs can and should serve as Site Recruitment Managers.  Why did you choose this topic for this audience? 

 

Beth Harper: As everyone is well aware, enrollment performance in clinical trials is quite dismal and hasn’t changed in the last 20 years that I have been focusing on this area.  I like to say that “Patient Recruitment starts with the patient but happens at the sites”.  Having an understanding of what sites are really doing to drive recruitment success is where the rubber meets the road in my view.  Further, in my experience, patient recruitment doesn’t happen by “spontaneous combustion” so without someone managing, supporting and overseeing site-level recruitment performance we are bound to continue to experience poor enrollment performance.

 

Nikki Christison: We chose this topic as recruitment continues to be a challenge, but also because we are seeing a large shift in responsibilities of CRAs in the past few years. With the implementation of risk based monitoring, CRAs are being pushed into a role as a site manager where they are often expected to manage all aspects of their sites, including enrollment, without being provided the resources or training they need.

Gretchen Goller: I think this has been a long-debated topic that many tout as the solution for all enrollment-ails.  Unfortunately, there is not much discussion on how or if this would work operationally.  The concept is discussed at a very surface level.  We seek to delve a bit deeper to specify what would actually have to be in place in order for this concept to become a reality.

 

When you use the term site recruitment management, what does this really involve? 

 

Harper: For me, recruitment management is about having a disciplined and systematic approach to understanding all of the following:

 

  

  

All too often, there are a lot of assumptions about what sites should and are doing to drive recruitment (and retention for that matter).  In many cases, the stakeholders rely on Patient Recruitment Organizations (PROs) to deliver on enrollment goals and while the support of a PRO can often be a value-added component, at the end of the day, it is the investigator’s responsibility to deliver on their enrollment commitment so having a process to determine and validate realistic enrollment targets along with a plan to achieve the goal is what recruitment management is all about.

 

 

Goller: I agree that the CRAs are the “face” of the company and their relationship with the sites needs to be leveraged from a patient recruitment management perspective.  This however requires a few things: clear mandates from management establishing this as a priority, empowering [CRAs] with the time and resources to focus on this, and ensuring that [CRAs] have access to the site level data and performance metrics so that they can effectively monitor and manage site performance. 

 

Christison:  While Gretchen makes some great points, realistically I don’t see that CRAs have the true authority or time to take on this role.  CRAs have multiple sites, and often multiple studies to manage with an abundance of responsibilities.  They are still often on the “road” several days a week so accessing the information about site performance is an additional burden on their time.  CRAs are often not authorized to make decisions related to funding for recruitment activities or budget management.  Furthermore, training and understanding of recruitment techniques, ideas and development of recruitment action plans take extensive time that frankly the CRAs just don’t have.  

Beyond the time and authority considerations that you have outlined, what are the knowledge, skills, and abilities needed to effectively manage site recruitment? Do you believe CRAs have or can develop these?  

 

Christison: I believe that CRAs could have the knowledge, skills and abilities, but often have not had the training and support to really develop this fully.  Recruitment management requires a number of soft skills and practical approaches that take practice to be comfortable with.  Some key skills that are required for recruitment management include conversational management, root cause analysis, negotiation skills, creative thinking and the like.  This may not naturally be part of the skill set that detail oriented, “heads down” CRAs have, who focus mainly on source document verification and protocol compliance.  Forcing CRAs who don’t have the right skill sets into having tough conversations with sites will be uncomfortable for both the CRA and the site.

 

Goller: From my perspective some CRAs do and some do not have the right set of competencies that Nikki describes.  For those who do not have the right tools, training (soft skills, strategic thinking, patient recruitment options, etc.) should be provided and the training needs to occur regularly and be reinforced. Management needs to provide that training to empower CRAs to have fruitful, collaborative discussions with sites that are not all about finger-pointing. For those that DO have the right skill set, they could be mentors for those who need some reinforcement in this area.  

 

Based on all of this, what is your advice? 

 

Christison: In our current environment where CRAs are constantly being asked to do more with less, they cannot take on the recruitment management piece as well.  If we ask this of our CRAs, we need to provide time, training, resources, and potentially redesign the role to allow for more authority.

 

Goller: The importance of the CRA role should be realized and leveraged at a higher level.  With this acknowledgement, senior management needs to implement changes to resource CRAs appropriately, to educate, train and empower CRAs to be an owner in the site’s recruitment success.  If our industry views this role as a crucial one in the enrollment process, we need to back that assumption with some tangible efforts and focus.  

 

Harper: Someone at the sponsor/CRO needs to support and manage site recruitment.  As I noted before, it won’t happen by “spontaneous combustion”.  Whoever is doing this should be skilled, at a minimum, in the basics of how to hold a productive conversation with the site about the elements outlined above: enrollment potential, patient sources, tactics, materials, outcome and action plans.

 

EDITOR’S NOTE: Harper, Christison, and Goller are also seeking input from the Clinical Informatics News audience. Through a short survey, they are seeking to better understand the industry views on the pros, cons, and process of having CRAs serve as site recruitment managers. They will present their findings at SCOPE and use the responses to shape the live conversation.  

* The Summit for Clinical Ops Executives—SCOPE, is organized by Cambridge Healthtech Institute, the parent company of Clinical Informatics News. It will be held in Orlando, Florida, February 24-26, 2015