Clinical Trials: virtual, remote, or decentralized?
What does it mean to conduct a virtual clinical trial? What about remote, decentralized, hybrid, or siteless studies? These terms are sometimes used interchangeably. But there may be value in distinguishing how these models can facilitate recruiting subjects and change the way clinical trials have traditionally been conducted.
Advances in mobile and digital health technologies have allowed investigators to expand their research efforts. Fitness trackers, smart watches, and video conferencing are just a few examples of the technologies that researchers are leveraging in their trials. This can allow them to expand data collection and recruit participants beyond their immediate communities, thus expanding their reach.
When the COVID-19 pandemic caused clinical trials to pause enrolling new participants in clinical trials, the ability to introduce remote or virtual visits, benefited institutions, research participants and research sponsors. Additionally, remote or hybrid trials may free up facilities at institutions allowing space to be available for other services to be provided. Research administrators should still consider the possible increased cost in staff, as some studies may require at-home visits and other coordination.
Additionally, more research subjects may have opportunities to participate in clinical research where they may not have otherwise. Patients for whom transportation to medical centers or research facilities were a barrier might now have access to both observational and interventional trials. Some leaders suggest that these kinds of virtual trials may finally herald the promise of patient-centric trials.
Experts believe that the move toward virtual trials that occurred during COVID lockdowns may continue even as society starts to open.
Decentralized trials (DCTs) are typically not run from a traditional research site. There may be a coordinating “hub” with a principal investigator and staff, but they are not necessarily headquartered at a specific location. These studies are usually designed to screen patients and enroll them online with e-consents. Research staff can conduct study visits using home care and/or telemedicine visits.
Some refer to DCTs as “siteless” trials.
Regarding remote clinical trials, over the past year we’ve taken this to mean that some or all aspects of a traditional clinical trial operating from designated research site are being revised to allow for activities to be completed remotely outside the physician’s office (e.g. shifting visits to telemedicine visits, arranging for blood work at a lab or at home). This may result in very limited or non-existent physical contact between the investigator and the patient or subject.
Impact on Protocols
The design of a protocol for a remote or decentralized trial should address many of the critical issues of a traditional trial. These are just a few considerations:
- Technology to be used to monitor patients — smartwatches, phones, etc.
- Frequency and logistics of video or virtual visits
- Procedures for home visits
- Where and how any necessary lab or blood draws will occur
- How participants will receive devices or drugs, in the case of interventional trials
Perhaps two of the biggest concerns regarding virtual trials of any kind are data privacy and the quality of the data collected. Any transmission of data over the Internet is susceptible to hacking. Likewise, the use of third-party smartphones and tracking devices leads to questions of their security.
Without direct professionally trained staff oversight, participants are left to their own devices. They must ensure receipt of medications or devices. They must store the medication appropriately, take it according to instructions, and often self-report. They may or may not be adept at the technologies being used.
Decentralized clinical trials existed long before COVID-19. The Clinical Trials Transformation Institute issued recommendations in 2018. The pandemic did accelerate the use of virtual and hybrid trials, however. Experts believe the trend will likely continue even as society starts to open. We will continue to monitor any regulatory guidance and trends in this area.