When you think of a clinical trial, you may picture an in-person visit to a clinic or hospital setting. While many clinical trials traditionally require participants to visit a research site, newer approaches allow some or many study activities to happen remotely.
Virtual clinical trials are gaining popularity in medical research because of their versatility and ability to gather data from participants across the country.
A virtual clinical trial is a study that takes place fully online. Because these trials rely on digital interactions, researchers typically use strategies like at-home technology and telemedicine to interact with participants.
Virtual clinical trials, which are typically 100 percent remote, fall under the umbrella of decentralized clinical trials, or DCTs. In a DCT, study activities take place outside a traditional clinical setting or hospital. This includes partially decentralized (hybrid) trials, where participants may take part in some in-person and remote activities, as well as fully virtual trials.
A virtual clinical trial differs from a traditional clinical trial with remote visits. Some clinical trials may be primarily in-person but allow virtual check-ins.
Simran Padam, MD, serves as Executive Director, Medical Affairs – Oncology for Worldwide Clinical Trials. According to Dr. Padam, the term “virtual” may not always be comprehensive.
“Many trials use a hybrid approach, where some visits happen remotely, and others still need to happen at a hospital or research center,” Dr. Padam told BlackDoctor.
It’s important to understand the full scope of a specific clinical trial before joining.
Instead of relying on in-person visits, virtual clinical trials utilize a range of tools to gather data from participants.
Shriya Das, a clinical trial project management and trial optimization expert, described the general process of a virtual clinical trial once a participant has joined.
“Telehealth visits with the study doctor replace clinic visits,” Das told BlackDoctor. “A mobile nurse may come to your house to draw blood, check vitals, or give an injection, or you’ll be sent to a local lab. If you’re on a study drug, it ships to you from a central pharmacy, tracked and temperature-controlled where it needs to be, and someone has to confirm you received it. You may wear a device, use a connected blood pressure cuff or glucometer, and answer symptom questions in an app, sometimes daily.”
“Behind the scenes, there is still a principal investigator, a licensed physician who is responsible for you and for the study, even if you never sit in the same room,” Das added. “There’s still an ethics board that approved the study and still monitors the data.”
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Potential benefits of virtual clinical trials include:
“From a clinical research perspective, another potential benefit is that we may be able to collect information about how a patient is doing more frequently rather than relying only on what we see during scheduled clinic visits,” Dr. Padam said.
With the benefits come a few possible downsides, such as:
“With everything being virtual, some aspects may seem impersonal to participants,” Das said. “When everything is mediated by a screen, that relationship is harder to build, and the participant quietly becomes their own study coordinator: remembering to charge the device, fill in the diary, be home for the delivery. That’s a transfer of workload, and it’s rarely acknowledged.”
One benefit of virtual clinical trials is access to a larger, more representative pool of individuals who otherwise may not have been able to participate. Research sites are not equally accessible to everyone, and transportation, work schedules, caregiving responsibilities, and distance can make participation difficult. While virtual participation may reduce some of those barriers, access to technology itself can create new disparities.
“We also have to think about people who may not have reliable internet, access to technology, or comfort using digital tools,” Dr. Padam said. “If we’re not careful, removing one barrier can unintentionally create another.”
Factors like digital literacy and accessibility can become barriers for some participants. This means that researchers need to consider potentially exclusionary factors when designing a virtual clinical trial, such as broadband access, device availability, language access, and accessibility. While virtual trials may improve access, they aren’t automatically more diverse.
Like any traditional clinical trial, virtual clinical trials prioritize participant safety, but cannot be guaranteed to be risk-free. However, virtual trials still go through research oversight, and participants should receive informed consent before taking part.
While the visits or activities may not be in person, safety monitoring will still happen remotely and/or in person depending on the study.
Because there is no in-person treatment, patients are encouraged to understand how the research team handles adverse events and emergencies.
“For me, the important question isn’t simply whether a trial is virtual,” Dr. Padam said. “It’s whether the study has appropriate safeguards in place to recognize potential problems quickly and make sure participants can get the care they need.”
It’s important to feel not just knowledgeable, but confident about a clinical trial before deciding to join.
Here are some questions you can ask the research team:
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If you or a loved one are interested in participating in a virtual clinical trial, here are a few resources to consider:
Decentralized clinical trials, which can be hybrid or fully virtual, continue to rise in popularity. Because people can participate from home or online, clinical trials may expand to include more diverse populations. Some benefits include easier access and reduced travel-related costs.
However, like any clinical trial, a virtual clinical trial is not without risk, and potential participants should weigh the pros and cons for their specific situation and ask questions.
Yes, however, participation requirements will depend on the specific clinical trial.
Yes, decentralized and fully virtual clinical trials are legitimate. Source your clinical trial options from legitimate databases like ClinicalTrials.gov.
A decentralized clinical trial, or DCT, takes place outside a typical hospital setting. DCTs can be hybrid or fully remote.
While fully virtual clinical trials are solely remote, some virtual or hybrid trials may still require occasional in-person visits.
Yes, cancer patients can participate in some virtual clinical trials. Note that these clinical trials tend to be hybrid rather than fully remote.
As with any clinical trial, financial compensation will depend on the trial itself. Some may pay participants; some may not.
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