“We aren’t conducting clinical research with the rigor that we should be today,” says thought leader Jeff Kingsley, DO, MBA, CPI, FACRP, CEO of the site network IACT Health. “We’re slow to change and slow to build needed infrastructure, especially at the site level.”
This aversion to change or being stuck in a mode where “it’s the way we’ve always done it” means clinical trials are damaged by the same avoidable mistakes over and over again, Kingsley notes. Worse, many of the mistakes happen at the site trial initiation stage.
“If a site makes a mistake, all you can do is clean it up,” rather than avoid costly notes to file and other corrective and preventive action–related headaches down the line, Kingsley says. Instead, sites must be incentivized to invest in technologies for electronic source (eSource) documentation, electronic regulatory submission aids, and artificial intelligence (AI) software, he says.
“Sites are the least sophisticated [players in the clinical trials environment], with the least deep pockets in this vertical,” Kingsley says. Translation: Sponsors must step up to help defray the costs of tools that will promote clinical trials. Kingsley advises sites to say, “This isn’t an investment for me—it’s to improve trial quality.”
Kingsley estimates he spends about $70,000 per year on eSource tools and $60,000 per year on regulatory tools, and has spent nearly half a million on AI at his various locations. He’s not expecting any one sponsor to pick up the tab. Rather, he’s advocating line item billing akin to the way sponsors work with contract research organizations. For example, a sponsor might add a $1,000 line item in its payment proposal to cover a site’s regulatory submissions costs on a complete trial. “Sites can’t eat the entire costs,” Kingsley says.
Developing Talent and Competencies to Achieve Effective Quality Management Systems and Risk Management Approaches
Join Jeff Kingsley of IACT Health, Susan Romberg of Premier Research, Sue Murray of Agios, and Steve Whitaker of PharmaPM Consulting at the ACRP 2019 Quality Congress next month for this engaging panel discussion.
Lest he sound like a negativist, Kingsley insists he’s quite the opposite after attending numerous events, as speaker and participant, over the past year. “I see industry starting to get it,” he says. “Lightbulbs are going off.”
Kingsley will be part of a panel discussion at the ACRP Quality Congress during ACRP 2019 in Nashville in April. “If we’re not communicating with others, we can’t know what they are going though, and we can’t understand how to better work together,” he says.
Author: Michael Causey