Virtual Sites and the Future of Clinical Trials
February 7, 2025During the pandemic, many aspects of life previously assumed to be impossible without a physical location were forced to go virtual. Traditionally, clinical trials have taken place in clinical settings within hospitals, universities and research centers. Researchers would travel between locations in larger trials to piece together what was happening where, and notes would be taken on paper. While many trials still work this way, another type of trial has emerged: trials on virtual sites.
How Virtual Site Clinical Trials Work
Virtual sites operate entirely electronically, with no physical location for patients to visit. Data is collected and stored electronically, eliminating the need for paper documentation. Secure platforms ensure compliance with client information safety standards and allow for remote access for team members to review data directly. Working with virtual sites offers numerous benefits.
Suzanna Langworthy, Senior Clinical Research Associate at Atlantic Research Group, is part of a research team that reviews the data from each site, protocol compliance, and staffing and facility adequacy for clinical trials. Each clinical research associate is assigned a portion of a trial to research and visit. She is currently working on her first virtual clinical trial site, and the main benefit she has noticed is the efficiency of the recording and sharing of information.
“A lot of times, when CRAs are traveling and onsite, we’re trying to piece together what happened at the trial site since the last visit,” Langworthy said. “With adverse events, we have to report them to the sponsors and the regulatory agencies. Sometimes, these events aren’t reported to people at my level. With virtual studies, we can take more proactive measures and have more oversight, making the study itself stronger.”
Increased Accessibility Through Virtual Sites
Patients in remote areas like rural Alaska gain increased access to clinical trials when they’re virtual. With onsite trials, patients in these areas may not realize the trials are available or have the means to access them. Even for patients in these less populated places, real-time data tracking provides immediate updates on patient progress, enhancing oversight and patient safety.
This benefit extends to everyone involved in the trial. Some patients struggle to travel due to their medical condition or the expense involved. Virtual trials make it easier for patients to participate, as they can avoid missing work for frequent in-person visits. These trials also offer cost savings for sponsors and researchers by eliminating the need for travel expenses.
Challenges of Virtual Site Clinical Trials
Communication between virtual sites and the study team is managed through electronic platforms, eliminating the need for physical interaction. However, challenges can arise, such as data discrepancies and the need for meticulous organization to ensure data integrity. Ensuring patient safety and data integrity is a top priority when working with virtual sites.
“From very early on, you have to set your process and go with it,” Langworthy said. “With virtual sites, things can balloon very quickly. Keeping up with data even between visits can really help. Even for a physical site, if I have remote access between visits, I can identify what’s going on before going into a visit. Due to what I’ve learned from virtual site trials, I will now be more prepared when going on physical site visits.”
Coordination of home visits also presents logistical challenges, requiring careful planning and documentation to maintain protocol compliance. Compliance with FDA regulations, such as part 11 compliance for all electronic platforms used for the virtual site, is essential, as is thorough documentation of all activities and data entries. By proactively addressing potential issues and collaborating with sponsors and site staff, conflicts can be resolved efficiently to maintain the integrity of the trial.
A Promising Future for Virtual Sites
Despite the challenges, Langworthy looks forward to seeing what the future holds for virtual clinical trials.
“I would be very interested to see them become more of a thing,” Langworthy said. “It takes time for people’s perception and openness to the thought of it to catch up. I’m really excited about the potential of virtual sites.“
The future of virtual sites in clinical research shows promise for increasing patient access, diversity and enrollment rates. While challenges exist, the potential benefits of virtual trials, such as shortened enrollment timelines and enhanced patient care, make them a valuable tool in the evolution of clinical research.
