“The FDA doesn’t call to ask if it’s a good time for an inspection,” Neala Lane, Associate Director, Quality Improvement Office at Indiana University told attendees of ACRP’s Virtual 2021 conference September 23. “They tell you when they are coming.”
As someone whose organization has been through nearly twenty FDA inspections – the most recent coming earlier this month – Lane is a big believer in preparing for inspections and using that energy and focus to improve overall clinical trial quality.
She doesn’t sugarcoat the situation, though. “Inspections are stressful, I’m not here to tell you otherwise,” she noted. That said, Lane and team have developed tools and tactics to “minimize” that stress to the point where it’s “no longer at the forefront of your mind” while you deal with the FDA inspector.
The goal, Lane says, is to create an internal climate focused on “progress, not punishment.” In other words, leadership should work hard to foster a culture where mistakes are opportunities to learn and grow. “Fear of punishment is a bad climate and can encourage people to hide” mistakes out of fear of retribution, Lane warned.
She also advised doing some pre-inspection work with the study PI. “FDA inspectors ask the PI what being a PI means to them,” Lane notes. The inspector, she believes, is looking for a philosophy and sense of commitment and engagement from the PI when they pose that question. “Go over the 1572 Section 9/Inspector Agreement document with the PI” before the FDA arrives for the inspection, she advised.
Earlier in the ACRP event, FDA officials Miah Jung, Pharmacologist, and Jan Hewett, Regulatory Counsel (Policy) at CDER stressed the importance of updating records on clinicaltrials.gov, a registry and results information database of publicly and privately supported clinical studies of human participants conducted around the world. The agency has begun issuing warning letters in recent months to entities allegedly failing to meet those requirements.
Jung noted that clinicaltrials.gov records must be updated every twelve months, and some data elements must be updated within thirty days.
“Transparency about the results of completed clinical trials enables important advances in the development of medical product[s] and helps ensure a safe, effective, and efficient clinical research enterprise,” Hewett said.
Kicking off the ACRP event, thought-leaders Kelly Willenberg, Manager, Kelly Willenberg & Associates, and Dawn Pittinger, Research Billing Compliance Manager, Moffit Cancer Center tried to help attendees better handle the inevitable conflicts that arise during a long clinical trial. “More conflicts aren’t being resolved today because of people not being in the office together,” said Kelly.
It’s even more challenging in a pandemic environment to finesse conflict in a positive way and prevent situations from turning into blame games, she said. “It’s hard to tell who’s at fault with a compliance problem in a remote environment,” Willenberg said.
“Things are often taken out of context via email and text communications,” Pittinger said, and even on video meetings it can be more difficult to “read a person’s body language.”
Pittinger and Willenberg agreed that listening and open communications are keys to mitigating the problem. “You’ve got to understand the other person’s issue” to positively defuse conflicts, Dawn said.
“Conflict is inevitable, but if you engage constructively, you can achieve something positive from it,” Pittinger added.
Author: Michael Causey