When we talk about decentralized clinical trials (DCTs), the conversation usually centers on the technology. Telehealth visits, wearable devices, and electronic patient diaries are transforming the world of clinical research, allowing investigators to capture data and monitor patients from afar.

DCTs and the technology that enables them were key to adapting to the pandemic. These tools made it possible keep critical clinical research afloat during lockdowns while rapidly initiating COVID-19 vaccine and treatment trials involving thousands of patients, which accelerated our ability to curb the global pandemic.

But DCTs require more than technology. There is an equally important human component driven by specialized study teams, including mobile research nurses and phlebotomists who engage patients where they live.

The pandemic proved that many elements of a trial can be conducted remotely. However, there are still key steps that demand a human touch. Patients often require tests or scans that can only be conducted by someone with medical expertise; they might need help with a treatment that requires an infusion or injection; and investigators may want an extra set of eyes when conducting telehealth visits, or assessing whether a patient requires intervention when experiencing a side effect or adverse event.

All of this is made possible by remote research nurses and phlebotomists, whose role in a DCT is to conduct house calls, providing protocol-required care and support to patients where they live. They help to create a patient-centric research experience that makes participants feel like their health needs are the top priority of sponsors. That helps attract and retain patients to these vital research programs.

The rapid adoption of DCTs in the pandemic proved that when sponsors combine state-of-the-art technology with personalized care delivered by mobile research nurses it eliminates barriers to trial participation while enabling the capture of consistent high-quality data. However, it also uncovered some confusion about what exactly mobile research nurses do, and what qualifications they require to be a part of the research team.

1. They can’t be deployed overnight. One of the most common misperceptions about mobile research nurses is that these resources can be deployed immediately to fill a gap. But, as with many elements of clinical research, it’s more complicated than that.

   These healthcare experts serve as an extension of investigators and their sites. And just like every other role on the clinical team, mobile research nurses and phlebotomists have to be registered and certified in their area of expertise, and they must be trained on the trial protocols, data collection techniques, and unique health concerns in the specific patient population. Investigators or CROs also need to vet and approve the healthcare workers’ credentials and onboard them into their own organizations before they begin working to ensure their performance meets the site’s quality expectations. A process that takes time and planning – effort that sets the team and the project up for success.

2. They should be built into the study during protocol design. Making mobile nurse visits part of the protocol design brings flexibility and speed to the trial plan. Even if the use of mobile nurses is considered ‘optional,’ it frees sponsors and sites to recruit patients from further away, even if they can’t reasonably attend any/all site visits; and provides a risk mitigation strategy if another health crisis prevents patients from coming to trial sites.

   That flexibility can open recruiting to a much broader patient population with potentially fewer sites and help to prevent the rushed adoption of a DCT model requiring last-minute deployment of mobile healthcare workers.

3. Sponsors need to be aware of local resources and regulations when deciding whether to use them. While the use of mobile research teams in clinical trials is not new, the widespread adoption of decentralized trials during the pandemic has driven their demand and deployment across geographies. In global studies, this means sponsors must navigate numerous regulatory environments, as many countries and regions have different rules governing mobile nurses and phlebotomists who visit patients’ homes.

   For example, the EU’s General Data Protection Regulation (GDPR) places parameters on what data study teams can collect, how they contact patients, and what details they can be given about a patient’s condition. Other regions will have varying rules about licensing, certifications, and who is responsible for the nurses’ conduct while caring for patients in their homes.

   These rules can determine how difficult it will be to find and work with mobile nurses in certain countries, and where their use may be unrealistic because specific regulations have not been issued yet.

   Sponsors who want to use mobile research nurses in global research programs, should partner with clinical trials organizations that have expertise in the regulations related to DCTs, and who can help them make decisions about where these experts should be used to maximize the efficiency of the trial design.

4. They should be factored into contract negotiations. Every DCT is unique, including how, when and where mobile research nurses will be deployed. Some mobile nurses will only support a handful of patients who live too far away to come to a site, or they will visit every patient, but only once to deliver a treatment as was the case in some COVID-19 vaccine trials. In other cases, mobile nurse teams will play a more frequent role, visiting patients multiple times following a strict trial calendar (e.g., on the fifth, tenth, and twentieth day after initial treatment.) On these visits they may only collect data, or they may perform assessments, tests or other medical interactions, and build a rapport with the patients.

   All of these details should be factored into the contract, along with payment details and terms. Planning ahead can help sponsors, CROs and sites avoid miscommunication about who is responsible for these resources, and how they factor into the broader trial strategy.

DCTs are here to stay. They offer the adaptability to reach and recruit the right patients – as well as the support structure, including local mobile nurses and convenient technology, to keep them engaged. Sponsors who believe that decentralized trials will be a permanent part of their clinical development roadmap going forward should consider and plan a mobile nursing strategy early on. When sponsors plan ahead and consider how they are going to vet and leverage mobile research nurses, they will get the most value from their DCT models.