Qualified mobile research nurses key to DCT success: Illingworth

Technology is key in launching and operating decentralized clinical trials, but people also are an important part of the equation. With virtual and hybrid studies on the rise, the number of mobile research nurses involved in facilitating these trials also is climbing.

Outsourcing-Pharma recently spoke to Illingworth Research Group's senior recruitment manager Alison Armstrong about exactly what a mobile research nurse does, what it takes to be one, and how to recruit qualified candidates among this highly specialized pool of professionals.

OSP: Could you please explain in a nutshell what a mobile research nurse is and does?​

AA: Absolutely! To put it simply, a mobile research nurse takes the clinical trial visit to the patient, wherever that patient is — the patient’s home, school, or workplace.

These specialist nurses conduct any part of the trial that does not rely on hospital-only equipment. They do physical exams, take blood samples, collect vital signs, give infusions, and, of course, report the collected data back to the site, sponsor, or contract research organization (CRO). For patients, this arrangement offers tremendous advantages because they don’t have to travel.

Patients who work or are in school have less time away; patients who are homebound don’t have to make complex travel arrangements; overall, lives are less disrupted.

OSP: How is the job description of a mobile research nurse different than that of a conventional home-health nurse?​

AA: The core difference between a mobile research nurse and a conventional home health nurse is their degree of experience within the research industry. Because they are exclusively dedicated to supporting clinical trials, mobile research nurses are all trained in Good Clinical Practice and other aspects of the clinical trial environment.

Conversely, a conventional home-health nurse would not be required to have an awareness of serious adverse event (SAE) and adverse event (AE) reporting, for example — knowledge that is crucial to the proper conduct of a research trial. A mobile research nurse is also trained in the use of specialized equipment that a traditional home-health nurse would have no reason to use.

OSP: What specialized training is required for such staff? What training and coursework are available?​

AA: While people applying to be a mobile research nurse do not necessarily need any previous clinical trial experience, they do need a degree as a registered nurse (RN) and certification from the state where they are practicing. Beyond that, all mobile research nurses must be trained in Good Clinical Practice; individual companies may offer additional training.

For instance, all Illingworth Research Group nurses work to a global set of standard operating procedures to ensure consistency for our sponsors conducting trials across the world. We also provide specific training in topics including advanced life-support, blood clinical practice, and handling dangerous goods, as well as specific education in the conduct of clinical trials.

Then a mentor works directly with the nurse through their first several visits. In general, the entire training process takes two to three weeks.

OSP: How do they obtain the necessary credentials to operate the specialized equipment required of them on their home visits?​

AA: Research nurse project managers, who are themselves nurses, work with the site and study sponsor to learn exactly what equipment will be used for the study, then create a training program and use it to train all the mobile research nurses involved with the study. At Illingworth Research Group, most of our equipment training is conducted virtually over video call by the Research Nurse Project Manager, so fortunately COVID-19 has not affected it at all. All the necessary equipment is sent directly to the nurse, and the virtual training sessions give them an opportunity to ask any questions.

Of course, if the equipment is more specialized and complex the nurse will be asked to go on-site to complete training. So, for instance, a centrifuge, which is obviously just a blood spinning machine, is quite simple to use and can be easily learned over video; a spirometry device may require a trip to the site.

AA: The pandemic has created a massive influx in companies wanting our services, since, obviously, vulnerable patients haven’t wanted to leave their homes, while sponsors need their studies to continue. At the midpoint of this year, we have already achieved 80% of our 2020 results. That, in turn, has created enormous challenges in finding the most highly trained nurses, as many nurses headed back to hospitals to support increased caseloads there. However, we equally have seen nurses wanting to offer support any way they could, so we have been able to continue supporting our clients.

Of course, there have been other challenges, starting with the vast pressure to ensure that research nurses have regular testing and are kept away from any COVID-positive sites. At the beginning there were also challenges in accessing the required personal protection equipment (PPE), and in simply being able to travel; some nurses reported 14-hour round trips to see their patients, with no available public transport or services stations. That’s dedication.

But back to the question about demand: It continues to grow. As the pandemic has progressed, patients have come to expect that mobile research nurses will be available to them. That level of convenience is becoming increasingly important to successful recruitment and retention.

In tandem, both sponsors and patients have a growing interest in decentralized clinical trials (DCTs), which rely heavily on localized data collection — whether through mHealth devices, local clinics, or mobile research nurses. These two drivers mean the demand for mobile research nursing will only continue to grow.

OSP: Do such personnel work directly for the CROs, are they contracted out, or is it a mixture?​

AA: Mobile research nurses work directly for a company, such as Illingworth Research Group, and are then assigned to each individual study; the mobile nursing firm is contracted by the biotech or pharma company or by the CRO running the study. This arrangement enables the mobile nursing firm to manage resources, safety systems, and procedures for the research nurses.

Often the nurses are hired on a flexible, contract basis; this gives the nurse ownership of their schedule, and the ability to determine how much work they want to do and when. At Illingworth Research Group we also have full-time equivalents in certain countries, including the US, the UK, and Spain. Because these nurses are fully committed to us, they can travel as necessary, covering visits and supporting our clients.

OSP: If someone is interested in engaging the services of a mobile nursing firm, what should they look for in such a company, to ensure they’re qualified and capable of providing the level of service necessary?​

AA: Generally speaking, it is the sponsor or CRO who hires a mobile nursing firm — but anyone hiring a mobile nursing firm should ask for a presentation covering what the firm can provide to the site, what services are covered, and what is not covered in the contract. Specifically, they should ask:

• How will working with the firm reduce the burden on the site and/or sponsor?
• What is the benefit both to the site and/or sponsor and to the patients in a study?
• What kind of oversight exists for Principal Investigator (PI) and registration of Letter of Assurance (LOA)?
• Are pre-engagement checks done on nurses? Are the nurses insured?
• How does the firm troubleshoot? Can they guarantee that a contact will be readily available?

Mobile nurses can help expand the pool of patients in a trial, reduce stress on participants, and minimize the chance of dropouts. They also free site investigators from smaller visit activities, such as blood draws, and allow them to pursue more complicated, higher-value services. They can clearly be a tremendous boon to a study, handsomely repaying any vetting process.