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 Northera (droxidopa) submitted by Lundbeck. Four sites were selected for inspection based on contribution to the efficacy of the study (i.e., the study would not have had a positive result if a site was excluded), large treatment effect compared to other sites, adverse events and number of patients excluded from either the per protocol analysis set or full analysis set. Inspections ranged from three to eleven days. Two sites received FDA Form 483s.
Dr. Gil was cited for:
- Failing to follow the investigational plan, specifically:
- EKGs were signed by the Principal Investigator up to 7 months late
- Failing to perform a protocol specified test within the post-dosing timeframe required by the protocol
- Failing to prepare and maintain adequate and accurate case histories, specifically:
- One study coordinator signed off on study form stating s/he performed two assessments that were actually performed by a different study coordinator
- The investigator signed off on a verification of eligibility form which did not have any questions answered regarding a subject's eligibility and the signature was not dated
- Inadequate investigational product accountability records, specifically:
- One subject received investigational product from a different study
- The study coordinator recorded one subject's medication adherence as 80%, but source records indicated that it was 50%
Dr. Lisk was cited for:
- One subject was enrolled with diabetic neuropathy against protocol eligibility criteria. FDA did not accept the investigator's position that diabetic peripheral neuropathy differed from diabetic autonomic neuropathy. FDA also notes that this patient was not included in the per protocol analysis.
- Two subjects did not maintain stable concomitant medication doses as required by protocol. FDA notes that the protocol was not clear, but states that the investigator should have sought clarification from the sponsor.
- The investigator up-titrated a subject's dose of investigational product, which was not permitted by the protocol.