As decentralised clinical trials continue to transform the landscape of clinical research, one thing remains constant: the vital importance of human connection. At the heart of these patient-centred approaches are mobile health nurses – highly skilled professionals who bring care, comfort, and clinical expertise directly into patients’ own homes.
Meet mdgroup mobilehealth nurse Sven
We spoke to Sven Schäfer, an experienced mdgroup mobilehealth nurse based in Germany, about what it’s really like to support patients in decentralised clinical trials, and why this role is so essential to their success.
We hear his perspective on the unique challenges and rewards of delivering trial-related care outside traditional settings. From the importance of empathy to the practicalities of at-home procedures, he shares insights into why nurses are key to making decentralised trials work – for sponsors, for research, and most importantly, for patients.
What led you to nursing?
“I have both vocational training as a nurse and further training as a specialist nurse in anesthesia and intensive care. I’ve also trained as an emergency paramedic.
I believe that my father’s illness with Guillain-Barré syndrome (GBS), a rare neurological disorder, with a months-long stay in the intensive care unit and extracorporeal assist system, set me on this path at a young age; perhaps even subconsciously.
Today, I am happy and proud to have taken this path.
During my professional career, I have always worked as an outpatient and have also worked in the emergency services. It was always interesting for me to see the patient’s background and social life.
Working in the patient’s home is a challenge because, as a Clinical Trial Specialist, you enter the intimate and private sphere of the patient. You are on your own during your work – therefore you need good skills, good preparation and a high degree of empathy.”
What type of clinical studies have you supported and how?
“I have been able to conduct many studies in my career. Whether pediatric or geriatric. Many neurological, oncological and cardiological studies. As an intensive care nurse myself, I come from a cardiology setting, so I feel very comfortable and confident in these studies. I have accompanied both drug studies and studies with medical devices.
Most frequently, this involves checking vital signs such as blood pressure, pulse and respiration. Very often, blood samples are taken, sometimes with a large number of samples and extensive processing of the samples on site at the patient’s home.
In some cases, study drugs are administered at home, both subcutaneously and intravenously. We also carry out SAE and AE reporting, as well as document and communicate a lot. Laboratory samples are prepared for shipment. Sometimes ECGs are written or spirometries are performed. The tasks are varied.”
mdgroup’s mobilehealth professionals are trained to deliver a wide range of clinical procedures directly to patients in their homes. See a sample of some of the procedures we can carry out here.
Have any patient stories or moments really stayed with you?
“Yes, there are a few. I accompany pediatric studies again and again. It’s very moving when medication from the study starts to have a positive effect and you experience the parents’ emotions. I have been accompanying some patients in trials for a very long time, sometimes for several years. It’s always like coming home.
The patient is always waiting with a cup of coffee. Empathy and communication must not be neglected in the patient’s home.”
Where do you see decentralised trials heading in the future?
“In my opinion, decentralized studies will be the future of clinical trials. With the inclusion of artificial intelligence, digitalization, future trends with New Work and Silver Ageing, as well as the trend towards lifelong health maintenance, studies in the patient’s home will be of great importance.
Without the study coordinators and, in the area of home trials, the travel nurses and all companies involved in home trials, it would simply not be possible to carry out the studies in patients’ homes.
The profession and the service are constantly evolving and developing! The studies are becoming more complex, the diseases are becoming more complex. The training and processing are becoming more extensive, more and more data is being collected, and the service to patients is also becoming more extensive.
Ultimately, you are a specialist service provider. I support these special services with my small company and look forward to the challenges every day.”
How do you keep the patient experience at the heart of your work in clinical research?
“I consider my work, my own company and the work of all my colleagues in home care and home trials to be indispensable! Closing this gap between patients and clinical research is long overdue and must be driven forward, especially in Germany. I look forward to further exchanges with all those involved and the future!”
Every patient is an independent personality and has their own story. They are the most important part of the study and I try to focus on this experience with my work and my skills!
Not only CROs, sponsors and the pharmaceutical industry, as well as PIs and study coordinators are components of a functioning study. It is above all the patient – I see them as part of the study team! If not the most important part…”
Mobile health services paving the way in decentralised clinical trials
In decentralised trials, patients can participate on their own terms. This has a direct impact on retention rates since up to 60% of patients see distance to study sites as a key barrier to enrolment and engagement.
mdgroup is committed to delivering remarkable, patient-centred experiences to keep patients engaged, informed, and supported throughout their clinical trial journey.
One way we do this is by offering our mobilehealth services that bring the clinical trials all the way to the patients’ own homes. This allows greater choice for patients to participate in studies while their needs are being met and supported.
Our mobilehealth nurses are at the heart of our patient-centred clinical solutions. As we heard from Sven, mobile health nurses enable patients, who otherwise wouldn’t be able to, to participate in life-changing clinical trials. Our nurses go above and beyond to ensure patients feel safe and supported while participating in studies in the comfort of their own homes.
In one of our recent case studies, we shared how mdgroup supported a single ascending dose hybrid clinical trial with complicated blood isolation practices. Through our highly skilled mobilehealth nurses at our clinical staffing agency, seacolehealth, we managed to train our nurses to become experts in this process. Learn how our expert mobilehealth nurses carried out their procedures at the patients’ homes across the US and what the outcome was here.
Learn more about mdgroup’s mobilehealth service today.
