You don’t need a crystal ball or tarot cards to see that so-called “virtual” or “hybrid” trials are part of the future when it comes to tomorrow’s clinical research landscape. “The technology is coming,” says Kim Kundert, RN, BSN, vice president of operations at VirTrial, LLC. “The time to get prepared is now.”
Kundert cautions advocates and naysayers of this future alike to take a deep breath, however. Technology is not going to replace the “human factor” and the importance of the relationships between patients, study coordinators, and principal investigators, she stresses. While the number of so-called “siteless” or hybrid trials will undoubtedly increase in the coming years, it’s not a zero sum game where rank and file clinical trial practitioners have to play Luddite and reject new technology.
Kundert will be part of a session at ACRP’s Southeast Regional Conference in North Carolina this week. The session aims to reassure clinical research coordinators (CRCs) that they’ll remain integral parts of the clinical trial process, even as they have an opportunity to let technology take some of the tedious administrative burden off their plates by letting patients engage in some interactions with the study team virtually.
Patients “enjoy the TLC and connection with the coordinator and their physician,” Kundert says. Technology can’t replace this factor, she stresses.
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At the same time, as a former CRC, Kundert is a big believer that there is a time and place for hybrid and virtual clinical trials—and that professionals who embrace that fact will be at a competitive advantage.
Kundert and her firm are offering a free training program to ACRP members to help raise the bar in virtual and hybrid clinical trial conduct. VirTrial’s Virtual Care Platform, which offers a patient management program combining video, text, and e-mail for clinical trial site professionals to easily address specific patient and study needs in a secure environment, is transforming the use of telemedicine in the clinical research industry.
Participants will take 15 minutes to complete four brief training modules, which will earn them a certificate declaring them to be virtual capable.
The training has only been available since August, but already industry is taking notice, Kundert says. “We’ve already had a contract research organization reach out and ask us to let them know who has taken the training as they prepare for a trial in a few months,” she notes. Sponsors have also expressed interest in identifying personnel who have earned the certificate.
“Sponsors want to see who is interested, willing, and even trained” in the conduct of hybrid and virtual trials, Kundert says.
Author: Michael Causey