Ed Seguine is a big believer in the power of technology to advance clinical trial quality, efficacy, and efficiency. So, why is he concerned by certain vendors’ promises made in the wake of the coronavirus to “fix” stalled clinical trials with their tools?
“Part of me is worried that if we do it in a hurried fashion, rather than as an intentional, purposeful choice, it will give the technology industry a black eye and [give doubters] an excuse not to do it,” Seguine says. He is CEO of Clinical Ink, a clinical technology company featuring an eSource platform and configurable electronic patient-reported outcome and clinical outcome assessment modules for capturing and integrating electronic data from sites, clinicians, and patients at the source.
While he’s bullish on ways technology can improve clinical trial operations today and especially long-term, Seguine is skeptical of claims he’s seen from other vendors implying their virtual or hybrid clinical trial technology offerings can help sites and sponsors “retool” clinical trials to cope with coronavirus or similar health crisis conditions. That is to say, coping with a world in which patients are limited in their ability to visit a site, and trial professionals limited in their ability to go to a person’s home or other location.
Unless a study is in pre-launch or very early in the process, Seguine’s not a big advocate of retrofitting trials. “I see it as almost busywork,” he says.
Like everyone else, Seguine is deeply concerned about coronavirus and its deadly impact. However, he also recognizes an event like this can sometimes be the impetus for an industry to take a hard look at its “structural dynamics” and consider new ways of doing things.
“Traditionally, clinical trials haven’t innovated on the operational side in the way they have on the product side,” Seguine notes.
Meantime, ACRP members have begun to embrace new ways of conducting trials in a landscape dominated by coronavirus fears and realities.
“We have been given permission to do phone or video visits only,” says Cheryl Myers, RN, CCRC, with Prisma Health-Upstate in Greenville, S.C. “We don’t have video visit capability, so we are doing phone visits.”
Prisma has had to delay taking vital signs and conducting other onsite procedures. It hasn’t stopped thinking creatively, though. In one recent instance, Myers recalls, “I was able to put my [investigational medicinal product] in a bag and hand it to the patient through their car window. I had them place their returned study drug in a garbage bag that I held out for them. I used gloves in the transfer, and I kept my distance in doing all of this. My sponsor approved me doing this before I put it in place.”
Author: Michael Causey