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 Lartruvo (olatumab) submitted by Eli Lilly and Company. Two sites plus the sponsor and the CRO managing the independent review of radiology images for the study were inspected. Site inspections ranged over seven to eleven days and the sponsor inspection lasted four days. One site inspected by FDA had inspectional observations.
Dr. Kim was cited for:
- Failing to report adverse events in one subject (increased confusion and falls) to the sponsor
- Reporting a serious adverse event (grade 3 hepatic hemorrhage) to the sponsor outside of protocol required timelines (approximately 3 weeks instead of within 24 hours)
Notable in the summary is that EMA inspected Dr. Tan and shared the results with FDA. FDA noted that the EMA had inspectional findings, but none that impacted acceptance of data from the site.
For the imaging review, FDA notes that the following were inspected:
"The inspection focused primarily on assessing the accuracy of the tumor response and disease progression source records as it pertains to the contractual obligations of the CRO. Subject source documents/records generated by the CRO for 79 subjects from four clinical sites were compared to the eCRF and data listings. Assessment of conduct of the Charter-Specified CRO responsibilities included training, education, and qualifications of radiologists, correspondence with clinical sites/sponsor, quality assurance, data collection and management, computer system validation and Independent Review Charter review and adherence. "