The Importance of Site Relations in the Implementation of Mobile Research Visits
The adoption of decentralized clinical trial (DCT) elements, including mobile research nursing, continues to grow. According to GlobalData, there were 1,291 DCTs in 2021, and the global DCT market size is projected to increase from $6.11 billion in 2020 to $16.29 billion by 2027, for a CAGR of 14.8%.
Even so, a recent ACRP survey reveals that DCTs are not a daily reality for clinical sites. “Nearly half of sites (47%) surveyed say that 1-25% of their clinical trials use DCT components/services, while 41% of sites say that none of their trials use them. Only 12% of sites indicate that more than a quarter of their clinical trials use DCT components/services.”
Home nurse visits as part of a DCT have the potential to significantly increase trial participant diversity and improve recruitment and retention. Still, those benefits will not be fully realized if sites and other stakeholders are not comfortable utilizing them. While the decision to incorporate home nursing visits into study protocols is typically made by the sponsor, the study design can and should consider the perspectives of key site stakeholders such as Clinical Research Coordinators and Principal Investigators (PIs).
Industry collaboration is on the rise
The DCT industry is rapidly enhancing collaboration with sites. A leader in this initiative is the Decentralized Trials & Research Alliance (DTRA) which is seeking to accelerate the adoption of DCTs with the goal of making research participation available to everyone. The DTRA Best Practices Evaluation Rubric provides a framework for best practices in five areas, including site impact. Per the Rubric, “Sites will have a continuing importance for DCTs. The impact on sites should be considered with any new practice, including the practical implications of adoption and change from today’s working practices to increasing DCTs.” Among the guidance is that any DCT method being utilized should result in “a net reduction in burden for both patients and sites [emphasis added].”
As sponsors increasingly involve sites earlier in the process of engaging with home nurse visit partners, some providers have already pioneered a partnership model that makes site engagement a key priority. Julie Church-Thomas led the startup of PCM Trials in 2008 and is now its Director of Site Relations, a purpose-built role that integrates the needs of sites, sponsors, and CROs. Church-Thomas is focused on engaging with sponsors, CROs, PIs, site coordinators, and other parties to help clinical sites better understand how incorporating home visits can assist them in achieving their trial goals of recruitment and retention. In addition, an essential part of her role is to develop and share best practices from sites with strong positive experiences utilizing home nurse visits.
“First impression is everything,” says Church-Thomas. “Having the opportunity to have a one-on-one call with the site early in the process to ensure the site’s understanding of our services and to gain their trust and confidence lays the foundation for the PCM Trials project management team moving forward.”
How clinical sites can benefit from home nurse visits
The notion of DCTs dates back to 2003, but it wasn’t until the COVID-19 pandemic that their usage increased exponentially, not necessarily by choice but by necessity. Over time, many in the clinical trials community have come to appreciate the value that this patient-centric, decentralized approach can bring. For example, according to a survey by CISCRP, “Travel to the study clinic remains a top burden of participation, with a quarter of respondents traveling over an hour one-way for in-person clinic visits. As a result, preference for virtual visits and reduced travel time are indicated.”
By eliminating the need for travel, home visits can reduce the burden on patients and caregivers and, in so doing, can lead to improved enrollment and retention. Removing the travel requirement also enables sites to expand their geographic reach, which is particularly important when conducting studies involving rare diseases or patients with mobility challenges. The convenience of home visits can also be an advantage in instances where similar trials are trying to recruit participants. According to Church-Thomas, “There is a large increase in sites which have had great positive overall experience using mobile visits to support their recruitment efforts and provide a valuable option for their patients even if, in some cases, it could entail some extra work or some initial concerns on the part of the sites.”
Ensuring nurse quality and accountability
A legitimate concern that sites have is the quality of the nurses who will work on their studies. Church-Thomas says this can be addressed by ensuring that the mobile research nursing partner is experienced and supportive of being vetted for their hiring and training practices. For example, PCM Trials directly recruits, trains, and manages nurses and hires only RNs or above. They also seek nurses with at least two years of experience in acute care settings, having found over the years that their skills and experiences are well-suited to the highly detail-oriented work required in a clinical study.
PCM Trials nurses also go through rigorous training on GCP, dangerous goods, portable equipment, technologies, and, of course, the specific study protocol. “Site personnel can view any of our nurses’ credentials that are provided as part of the regulatory files and, upon request, can even meet our nurses in person prior to the first visit,” says Church-Thomas.
Some PIs are hesitant to use a nurse they do not directly employ, but Church-Thomas shares that all mobile nurses sign the Delegation of Authority Log, and the site receives the regulatory-required documents for the assigned nurse. The mobile nurse works cooperatively with the PI and Site Coordinator to ensure the participant visit meets the protocol requirements and is conducted and documented with the same quality as an on-site visit. Any safety concerns are communicated directly to the site and the PI.
Finally, PCM Trials have found that sites become more comfortable with home nursing visits once they realize that they are easier to implement than they may have assumed. “Those who are not familiar with mobile visits assume that they will have to do all the scheduling, provision of equipment and supplies, training, billing, and courier arrangements but, in reality, we handle all of those things,” explains Church-Thomas.
Moving forward into a decentralized future
As the ACRP study concludes, “Site perceptions strongly influence DCT acceptance” and, as such, it is in the best interests of all involved to thoroughly address site concerns when designing a study and choosing providers. Only then will the promise of DCTs be fully realized for the benefit of patients and the industry.
“The use of mobile research nurses gives sites the advantage of being able to expand their geographic reach and address transportation and scheduling issues,” says Church-Thomas. “Home visits can help sites improve recruitment, retention, and compliance by putting their patients first and making it as easy as possible for them to join the study.”