Leverage FDA Inspections to Improve Clinical Trial Operations

Neala Lane, MS, CCRC, Associate Director, Quality Improvement Office, Indiana University

When the U.S. Food and Drug Administration (FDA) calls to say it’s coming to inspect your study site, “it’s like a bomb drops, it’s total chaos,” says Neala Lane, MS, CCRC, associate director of the Quality Improvement Office at Indiana University (IU). She ought to know; she’s been through 19 inspections in the past five years.

Don’t count on always having lots of time to prepare for an inspection, Lane adds. “We get calls on Thursday saying they’re coming Monday,” she notes.

There are several factors contributing to IU’s relatively high number of FDA visits, Lane explains. “We’re a large academic medical center that conducts a lot of FDA-regulated research,” she says. Plus, the institution has the “lucky” geography of being about a mile down the road from an FDA inspector.

Lane jokes about the lucky geography, but she and her IU team members have decided to use it as a motivator to be an even better organization and to share their experiences with other clinical trial practitioners. “We like to share our insights and experiences in the spirit of industry cooperation,” she says.

Lane will unveil those insights and best practices through a session during the September segment of the ACRP 2021 virtual conference. Among her tips, she says it is important to establish an in-house point person who can act as institutional memory and help guide others through the actual inspection.

“It’s rarely the same coordinator who is inspected” from one FDA visit to the next, Lane says. As point person, she assists any study coordinator or other practitioner involved in the inspection. “It’s comforting to them to know I’m with them every step of the way,” she adds.

Lane also advises against institutional amnesia after an inspection. “Most sites are so grateful to survive an inspection; they shake off their PTSD” and try to focus on other things when it’s over, she notes. Clearly though, while it’s important to keep trials moving, inspections are also an opportunity to learn how to be better, and offer a chance to make the next inspection that much smoother, she says.

She’s also a big advocate of developing an inspection plan for before, during, and after the event. “Inspections are inherently stressful, but plans and other action steps can minimize” the strain, Lane says.

Sometimes it requires a big picture policy change, too. For example, Lane champions a culture where mistakes are treated as opportunities for growth and not part of a blame game.

“Use mistakes [discovered during an inspection] as a way for everyone to get better,” she says.

Author: Michael Causey