Virtual Clinical Trials

What is a Virtual Clinical Trial?

Clinical trials study the effects of different interventions – experimental drugs, vaccines, surgical procedures, devices, and even lifestyle modifications – on people. Clinical trials rely on clinical trial participants - volunteers who donate their time and effort to help make the trial happen. For many people, some of the biggest barriers to participating in a clinical trial are geographical. Even if you find the right trial for you, there might not be a clinical trial site (a hospital, doctor’s office, or other healthcare facility taking part in the trial) in your area. Research has shown that 70% of all potential participants live more than 2 hours away from the nearest clinical trial site. Virtual clinical trials use technology – mobile devices, apps, or online platforms – to help connect trial participants with researchers remotely. As our technology capabilities grow, virtual clinical trials are playing a bigger role in helping to bring the clinic to the participant. Virtual clinical trials are also referred to as “decentralized clinical trials” because they do not require participation at a physical clinical trial location.

Understanding Traditional Clinical Trials

Historically, clinical trials have relied on in-person visits in which a participant is required o travel to a research site, usually on a regular basis for the duration of their participation in the trial. During these in-person visits, a trial doctor or other members of the site staff will give the participant a check-up; ask about their symptoms, medications they were taking, medical problems they might be having; and run tests or ask questions to learn how the participant is responding to the experimental treatment.

Benefits of Virtual Clinical Trials

Virtual clinical trials take a different approach. They allow participants to use technology advances, such as tele-health visits, wearable devices, and online platforms, to complete their trial site “visits” from home or virtually anywhere. Many clinical trials use virtual capabilities in a hybrid or mixed model that combines traditional and virtual trial designs. A mixed model allows participants to have remote trial visits unless an in-person visit is preferred by the participant or necessary. For example, some clinical trials allow participants to receive some of their regular visits through a telehealth visit, requiring an in-person follow-up only if it’s needed. Other trials allow participants to complete certain parts of a trial site visit at home, such as answering questionnaires, which reduces the amount of time required for the in-person visit when they do come into the clinic. The end result is reduced burden on the participants and greater access to clinical trials for participants in remote locations. This has the potential to lead to more people, including more diverse populations participating in clinical trials , greater participant satisfaction, more accurate data, and greater efficiencies for trial sites and sponsors.

Challenges of Virtual Clinical Trials

• Virtual clinical trials are not always feasible. For example, participants in an oncology trial might need to have scans of their tumors so their doctor can determine how the cancer is responding to treatment.
• Virtual clinical trials require more electronic data management. Because virtual clinical trials make it easier to collect data, these trials have the potential to generate large quantities of data that need to be analyzed and, even more importantly, protected. Virtual clinical trial sponsors need to take additional measures to safeguard participant privacy.
• Virtual clinical trials require end-users who are trained to use the technology. Virtual clinical trials allow people to participate remotely. They also allow people to take a more active role in their clinical trial and in their healthcare, empowering participants to collect and report data in real time (and on their own time). However, as with any new technological innovation, people will likely need training to use virtual clinical trial devices, apps, and platforms. Improper or insufficient training can lead to data collection mistakes, low-quality data, and poor communication between a trial participant and their healthcare provider or the trial sponsor.

Using Virtual Capabilities to Make Tomorrow's Clinical Trials Successful

The potential solutions that virtual clinical trials offer – to trial participants, sites, and sponsors – can outweigh the challenges they present. Trial sponsors are leaning more heavily on virtual capabilities to recruit participants and conduct trials online. This push has accelerated in recent years as the COVID-19 pandemic made in-person site visits more difficult. As a result, those running clinical trials have had to consider new strategies that would include tools of virtual clinical trials, including greater access to telemedicine, virtual site visits, and alternative locations for patient assessments outside of the physical clinical trial sites.