Fresh from completing enrollment this week on a 120-person, in-patient COVID-19 clinical trial, Jessica Thurmond has learned a thing or two about conducting a trial under intense conditions with condensed timelines and unique pressures.
“We try to fit trials into a box, but what happens when the box no longer exists?” she asks. In the case of Thurmond and team, loss of the box meant it was time to think outside it, with a new attitude toward using new technologies and ways of conducting trials, she says. “We really changed the way we looked at clinical trials,” says Thurmond, ACRP-CP, a clinical trials manager at Clinipace.
First, it required flexibility. The COVID-19 trial was expected to utilize 10 sites. Instead, Thurmond and team ultimately worked with 34, including many smaller sites in less densely populated regions. The trial enrolled its first patients in May, and wrapped up September 10 by meeting its enrollment goals.
Second, it required speed. For example, some sites in Thurmond’s trial went from sign-offs on the Clinical Trial Agreement with the sponsor to activation within 24 days.
Thurmond and team also found innovative and effective ways to work with principal investigators, such as using engaging and more nimble question-and-answer sessions during site initiation visits rather than relying on longer, slower, one-way presentations as much.
While the jury is still out industry-wide as to what the long-term impacts of COVID-19 will be on how clinical trials are conducted, Thurmond believes much of that change is here to stay. “When sites, contract research organizations, and sponsors see the results [of COVID-19 trials], they’ll realize we can conduct trials in new, cost-effective, and efficient ways without sacrificing data integrity,” she says.
Author: Michael Causey