FDA did not post any warning letters to Sponsors/Monitors/CROs, IRBs or Clinical Investigators this week. From the archives, here is the Clinical Inspection Summary for Imfinzi (durvalumab) submitted by Astra Zeneca. Three sites (out of the 79 that participated in the trial) plus the sponsor were inspected. Site inspections ranged from four days to five weeks. One site received a FDA Form 483.
Dr. O'Donnell was cited for the following (Note: He was the third PI at the site, but was cited for all regulatory violations on the study):
- Reporting seven Serious Adverse Events outside of protocol required timelines. FDA notes that four of these events were not included in the BLA data listings because the cut-off date was missed.
- Listing that three subjects had withdrawn consent when they had not. FDA notes that this meant adverse events were not reported as required after the treatment period.
- Forty-two (42) adverse events were not reported to the sponsor as required for four subjects. FDA required that a sensitivity analysis be performed on the study datasets with the data from this site removed, in order to determine if the under-reporting of adverse events from this site affected study outcomes.