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 Blincyto (blinatumomab) submitted by Amgen. Three sites plus the sponsor were inspected. Sites were selected for inspection based on response rate, as well as enrollment. Site inspections ranged over five to seven days, and the sponsor inspection took place over nine days. One site received a FDA Form 483.
Dr. Laron was cited for:
- Failing to properly execute informed consent
- Site personnel who were not delegated to obtain informed consent consented two patients
- Three subjects were not consented to a revised consent that contained new risk information.
- Failing to properly report adverse and serious adverse events
- Failing to report febrile neutropenia which prolonged a hospitalization
- Reporting another case of febrile neutropenia within 11 days instead of one day.
- Reporting upper limb tremors within 5 days instead of one day.
- Failing to report a rise in LDH and increased risk of tumor lysis syndrome in one patient.
- Reporting steroid induced myopathy over one month late. Additional events related to this led to the patient's death, which was also reported late.
- Failing to adhere to eligibility requirements for the study
- Enrolling two subjects who did not meet the criteria for hemoglobin values.
Additionally, the FDA notes that subinvestigator Financial Disclosure forms were not collected at the time two subinvestigators began participation in the trial, serious adverse events were not submitted to the IRB as required in some cases and some subinvestigators lacked documented training to the protocol.