As a “green, young, and inexperienced” clinical trial practitioner, Teri Crumb, MSN, RN, CCRC, now a pediatric clinical research nurse at Spectrum Health/Helen DeVos Children’s Hospital, once let a sponsor “sweet talk” her into believing the electronic data capture (EDC) component of its fledgling study was ready for prime time. It wasn’t.
From that experience, Crumb learned a valuable lesson she has since used to change the way she conducts her practice. “Everything must be worked out” before you engage patients when it comes to issues like preparing for EDC, shipping of investigational products, and securing a central lab for a study, she says. Crumb learned she should have asked more questions and waited for more compelling evidence to appear before she moved forward with patients.
“I’m sure experienced clinical trial practitioners are surprised by my naivete,” but such early-career errors are probably more prevalent than many like to admit, Crumb says. She’s committed to sharing her best practices, favorite tools, and a few professional scars earned along the way with others. “We can learn from mistakes and mitigate risk,” she says.
“What Joy Jurnack said [in a recent ACRP blog] about learning from the past really resonated with me,” Crumb adds. “We must learn from our history.”
Honey, I Blew Up the Research Study: How to Come Back from a Bad Study
Join Crumb and Emory University’s Dr. Margret Kamel at ACRP 2022 this April when they will share their experiences in “studies gone bad.” Errors happen, but you can learn from the mistakes of others and walk away with practical tips for recovery. As they say, “you do not want to be left singing ‘Oops, I did it again.”
“We have to learn from our mistakes,” said Jurnack, RN, CCRC, FACRP, a quality assurance specialist. Working together, study coordinators, investigators, and the rest of the clinical trial team can “connect the dots” to ensure patients are treated safely and honorably, and trials are conducted with the highest possible level of professionalism, she added.
Crumb couldn’t agree more. “Perfection is even more important now because we have been forced to limit some patient contact due to the pandemic,” she notes. “Mistakes do happen,” she adds, but “we can learn to mitigate the risk with better study preparation.”
Author: Michael Causey