The COVID-19 pandemic has dramatically accelerated the adoption of digital technologies. Just as remote video conferencing is changing how we conduct business, telehealth (also known as virtual visits) is set to change the way we conduct clinical trial patient visits. Both technologies were quickly embraced as the COVID-19 pandemic took hold, enabling people to remotely complete tasks that were once done in person. And like remote work, telehealth can be extremely convenient, saving patients and sites countless hours. By considering the perspective of key stakeholders, including patients, sites, and regulators, we can see clearly just how important this technology will be moving forward. 

 

The Patient’s Perspective

Site visits are one of the most difficult components of clinical trial participation. For populations such as young children or the elderly, it can be a particularly burdensome, all-day affair. Visiting the hospital means traveling, likely with a caregiver, and often the use of expensive cab services. Children may need to miss school. They may be asked to wait for long periods of time, shuffled from one room to the next, or even be exposed to dangerous pathogens. Seniors suffering from a serious illness could suffer a fall walking into a facility. When you think about the ethical considerations around forcing someone to travel to a hospital when a remote visit may suffice, it becomes clear that telehealth should be available to patients when it does as good a job as an inpatient visit, or when it can be used to triage whether an inpatient visit is necessary. 

 

The Site’s Perspective

The regularity with which individual sites handle clinical trial patients can vary dramatically. While larger sites may have staff highly familiar with your protocol, all too often site staff face significant challenges efficiently processing patient visits, which can significantly compromise the patient experience. This is especially true for smaller sites with less research infrastructure. Telehealth is one way to address the challenges at smaller sites. By using telehealth, sponsors can automate the task of managing patient intake, allowing clinicians to start remote visits with the click of a button, which significantly reduces the burden on smaller (or larger) sites. For these smaller facilities, the addition of telehealth tools can be an enormous help in consistently providing a positive experience for patients while reducing workload. 

 

Larger sites may have IT requirements of their own. Because of this, the best time to discuss these concerns is during the initial negotiations. “Most sites tend to be OK with using the sponsor’s telehealth solution on their network as long as it is part of the initial negotiation process.” explained Dr. Paul Glimcher, Datacubed Health CSO, and Professor of Neuroscience at NYU Langone Health. “It’s harder to do after you have that signed. Still, most sites understand that if you’re running a 30 site study, you have to use one platform” 

 

The Regulator’s Perspective

Even if the technology and patient benefits are clear, it means little if their adoption interferes with regulatory approval. Study teams preparing for clinical trials should (and must) get the FDA to approve their protocol. And while sponsors should review these tools with the FDA, a recent rule change has clarified that sponsors can move forward with leveraging remote engagement tools wherever necessary and feasible, highlighting a few key considerations¹:

 

  1. Feasibility of assessment method
  2. Variability in data collected remotely
  3. Appropriate audit trail documentation
  4. Available technology and technical support required

 

To Sum it Up

Remote engagement tools like telehealth are set to change clinical trial site visits in the same way remote work is changing businesses across the United States. Telehealth makes participation easier for patients (especially children and the elderly). It enables smaller sites to provide a higher-quality, more consistent patient experience by eliminating patient reception and intake processes. Finally, telehealth is a preferred tool of regulators to enable study teams to conduct clinical trials while reducing patient burden and improving safety. 

 

 

 

  1. United States, Food and Drug Administration, “FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency.” FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency, 2020.