Protocol violations and faulty record-keeping habits continue to be among the most common problems uncovered by U.S. Food and Drug Administration (FDA) inspectors, says David Burrow, PharmD, JD, acting director of the Office of Scientific Investigations within the Office of Compliance for the FDA’s Center for Drug Evaluation and Research.
Burrow’s tip? Remember that “quality is a process that starts from the ground floor.” He wants clinical research professionals to think of the foundation of successful clinical trials being the proactive work done on the front end. Done properly, it can minimize problems down the line.
It’s a simple and oft-repeated mantra, Burrow admits. Still, it bears emphasizing.
Burrow and several colleagues from FDA will interact with attendees at the upcoming ACRP 2017 Meeting & Expo in Seattle, WA, in an informal setting to address compliance questions and the FDA’s latest thinking on enforcement trends.
It’s worth noting, however, that Burrow will emphasize the proactive approach, as opposed to fixating on a single issue further down the operational path of a trial. He will also discuss the latest in FDA BIMO (Bioresearch Monitoring Program) compliance and enforcement trends during his ACRP 2017 session, “CDER BIMO Compliance and Enforcement: What You Need to Know!” View ACRP 2017 Program and Schedule
The quality onus isn’t just on those who roll up their sleeves to conduct the actual trial, Burrow emphasizes. “All of us in industry need to make sure we understand our commitments” to ensuring a reliable network, high-quality data, he says. In addition to study staff, it’s up to sponsors, investigators, and regulators to be clear on their roles and responsibilities, he notes.
Author: Michael Causey