The impact of the COVID-19 pandemic on clinical trials has been well chronicled in recent months, with new and ongoing studies targeting a number of diseases, particularly chronic conditions, being hit hard by reductions in patient participation.
This has shifted fundamental approaches in clinical operations, with some pharma sponsors turning to digital and remote models to overcome development bottlenecks. One such example is mobile research nursing, where trained practitioners provide patient concierge services at a participant’s home, school, or place of work.
In the discussion ahead, Jules Moritz, chief operating officer, and Juliet Hulse, senior director of global research nurse strategy and patient advocacy, both of Illingworth Research Group, answer questions from Pharmaceutical Commerce on the rise of mobile research nursing and its role in helping improve the participation and completion rates of clinical trials.
What types of studies or activities are most appropriate for mobile research nursing?
Any trial that includes assessments that are within the licensing scope of nurses is appropriate. Mobile research nurses can conduct many assessments and collect many different types of data away from the clinical site to help reduce the burden of trial participation on patients and families. Among the more common activities that nurses can undertake are the collection of routine biological samples such as blood, urine, sputum, etc. Mobile research nurses can also administer investigational products (IP), depending on the type of IP, route of administration and local laws. These considerations can vary by country or even state in the US.
Mobile research nurses can perform other aspects of clinical trial activities as well, such as the placement or removal of wearable technologies used in a clinical trial, perform nursing assessments regarding specific body systems or overall health, assist the patient during a telemedicine visit with an investigator, assess compliance with the IP dosing schedule, and ensure completion of specific scales or patient-reported outcomes measures.
In some cases, mobile research nurses may be asked to be at the patient’s location to receive the IP from the site or a depot and prepare it for administration, which is often the case if the IP is administered through injection or infusion. Mobile research nurses can even support blinded IP administration preparation and administration when necessary.
What’s the best way for a company engaging in clinical research to get the most out of this approach?
The key to maximizing the value proposition of including mobile research nursing in a trial is in the trial design stage. It is most efficient to introduce the concept of mobile research nurses completing some or all of the study visits at the time that the protocol is being written. Considering the inclusion of mobile research nursing at this time allows for a purposeful evaluation of the schedule of assessments/schedule of evaluations in the protocol to determine which visits might be amenable to being conducted off-site with the assistance of a mobile research nurse.
When developing a patient-centric protocol, a company might ask itself, “Is this assessment/evaluation/sample collection required? If so, is it required to be completed/collected as frequently as we are currently planning? If so, can we collect this data off-site? Does the patient truly have to be on-site to provide this data?”
What clinical trial training requirements do mobile or home-health nurses have to undergo?
Mobile research nurses have to undergo specific training that ensure compliance with good clinical practice (GCP) on top of their existing nursing credentials. Many nurses may meet this requirement by completing a course in GCP.
Then, of course, the mobile research nurse has to be trained on the specific protocol for which they will be conducting off-site visits. We believe that a read-through of the protocol is not enough, so we have a robust multi-step protocol training process that ensures the nurses truly understand exactly what they should be doing.
There may also be training related to the use of some of the equipment that the mobile research nurses use while conducting their off-site visits such as syringe pumps for the delivery of investigational products subcutaneously or handheld dynamometers to capture muscle strength data.
What are one or two potential lessons or best practices that may emerge from the COVID-19 pandemic in operationalizing mobile research nursing?
Among the things that we learned in responding to the pandemic is that there is a great need for flexibility in such times of public health crisis and, yet, in order to provide the highest level of service to our patients and to our clients, that flexibility has to be balanced with realism and pragmatism, both of which requires frank and honest communication between the client and the mobile research nursing provider. It is critical to be as transparent a process regarding start-up processes and timelines, especially for complex trials, so that everyone is on the same page and expectations do not go unmet.
We also came to realize that the scope of what mobile research nurses can and cannot do in an off-site setting is not well understood in the industry and so we were presented with some requests that were clearly outside the scope of the nurses’ remit per their licenses.
Finally, we learned that we could never be too prepared. We had to think about every aspect of how we deliver our service, from identifying, recruiting, and training nurses to the management of investigational product and biological sample couriers. We had to ask ourselves “what if” over and over again to make sure we had a plan for every contingency. “What if the courier is not permitted into the site to pick up the investigational product?” or “What if one of our nurses is exposed to COVID-19 while performing a visit?” Each of these considerations needed to go through the “what if” test a number of times to ensure we had already thought of a solution or a workaround if or when they happened.
Like most companies, we set up a COVID-19 response team that coordinated all of these activities and ensured timely communication of decisions and policies throughout the company and to our clients. This team continues to meet to manage our ongoing response.