“So many of the struggles facing clinical trials are 1990s problems,” says Henry Levy, general manager at Veeva. “Locating documents, duplicate data entry, [and] manual requirements” are just a few of the stubborn obstacles clinical trial practitioners have grappled with for decades. “There’s too much paper, and sites hate it,” Levy adds.
And where the drug and device industry often receives high marks when it comes to product innovation, it doesn’t hear much praise for how it has evolved, or not, when it comes to business operations. “If the clinical trial industry was like the space industry, you’d see amazing rockets being delivered to [the launch pad] by horse and carriage,” Levy says.
Asked to list out their biggest challenges in handling information and data flow, 67% of the more than 500 respondents to a recent Veeva study cited “manual processes,” followed closely by “tracking and reporting” at 62%, “misfiled/missing documents” at 48%, “governance and oversight” at 46%, and “duplicate data entry” rounding out the top five problems at 45%.
Like many in the industry, Levy is hoping there is at least one good thing to come out of the COVID-19 pandemic. The positive performance of technologies promoting virtual and hybrid trials during the crisis have become “proof points and a possible catalyst” to push the clinical trial industry toward embracing and retaining new ways of operating, he says.
In a bad situation only “amplified by COVID-19,” Levy notes that clinical trials are “slower than they were a decade ago.” The clinical trial industry is marred by “disjointed, slow site and sponsor communication and a high patient burden” for those who want to participate, he adds.
“There’s very little good in this current [pandemic] situation, but for me one thing is it’s pushing us to adopt new technologies,” Levy says. “Before COVID-19 there was a big debate about remote visits,” but the technology has more than proven it’s ready to shine, he adds.
Author: Michael Causey