Will Virtual Clinical Trials Transform the Trial Landscape?

John Reites, Chief Product Officer and Partner with THREAD

Ready or not, virtual clinical trials (VCTs) are here to stay. As new technologies make them easier to conduct, and as patients demand more flexibility to participate in trials, this new way of doing business will only become more attractive and prevalent, says John Reites, chief product officer and partner with THREAD.

“Remote virtual trials are not new,” Reites says. “I was working on my first ones in 2011.” However, the sheer number of virtual trials is growing, transforming them into a more powerful force in the healthcare landscape.

Wary clinical research coordinators (CRCs) shouldn’t get hung up on becoming technology experts, Reites says. Instead, they should learn the basics of how VCTs are conducted, and how the availability of VCTs is likely to change the way they work.

Training and educational programs are a key to practitioners’ future success, Reites notes. “It’s less about tech support, and more about understanding how to use the technology to the best advantage,” he says. However, it’s also not about “throwing an app at someone,” he adds. Instead, it’s about seeing a VCT as a powerful and effective new way to collect and harness data.

The effort is worth it, Reites stresses. There are potential benefits from multiple viewpoints when using VCTs, as listed below.

 


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Study benefits:

  • Modern research experience for patients and sites
  • Reduced research costs
  • Accelerated timelines
  • Continuous data collection
  • Potentially more frequent safety review
  • New endpoints, measures, and data context

Patient benefits:

  • One app to engage, contribute data, and conduct visits
  • Value and support specific to the patient population
  • Reminders/notifications to keep to the study schedule
  • One-click support to call, route to call center, or conduct a telehealth visit

Site benefits:

  • Instant and continuous view of patient data
  • Decreased onsite visits and increased interaction
  • Identify “at risk” patients and/or safety alerts in between onsite visits
  • Reduced administrative burden when technology is alleviating, not adding, to workload

Reites says he’s observed less “anxiety” among CRCs exploring VCTs today when compared to a few years ago. That’s a positive trend, but there’s more to be done.

It begins with understanding the risks associated with VCTs, including:

  • Patient safety management process
  • Continuous data review required
  • Less face-to-face, in-person interaction
  • Technology learning curve
  • More data being collected
  • New or revised standard operating procedures may be required
  • New solutions for study teams to learn

“I tell people that, even though you may not be ready to run [and conduct a VCT], you need to start crawling and walking today,” Reites says.

Author: Michael Causey