The US Food and Drug Administration (FDA) has voiced concerns regarding the research conditions at a clinical site involved in a Phase III trial evaluating Genentech’s antiviral Xofluza (baloxavir marboxil), a unit of Switzerland-based Roche (SWX: ROG), for the reduction of household transmission of influenza. While the concerns appear to be related to a different, unnamed study, they also pertain to the conduct of certain staff members at the site.
The regulator published a letter, issued earlier this month to the lead investigator, stating that her January 2023 response to an inspection from the previous year was deemed insufficient. Although protocol deviations during recruitment were acknowledged by identifying a misbehaving research coordinator, the letter’s recipient failed to provide adequate details on ensuring proper supervision of personnel. The letter also seeks a description of new standard operating procedures and staff training measures implemented to prevent similar violations.
According to the public data, as of November 13 this year, the site had been removed from the list of locations participating in the Roche trial, which now includes 266 other sites.- Flcube.com
