Sites that conduct clinical trials of biologics and have a suspiciously perfect record have an elevated chance of being inspected, Christine Drabeck of CBER’s Division of Inspections and Surveillance said at FDAnews’ Fourth Annual FDA Inspection Summit. In choosing which sites to inspect, “we have to weigh a number of factors, but it’s not a random process,” she said. Sites are more likely to be selected if their results “lack the variability expected in real-world research,” Drabeck added.
Clinical Trials Advisor