FDA Clinical Inspection Summary: Lynparza (olaparib) submitted by Astra Zeneca

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 Lynparza (olaparib) submitted by Astra Zeneca. Four sites from the pivotal study were selected for inspection, primarily based on enrollment. Site inspections ranged from 4 days to two weeks. 

Dr. Matulonis was cited for enrolling a subject with clear cell ovarian carcinoma rather than the protocol required serous ovarian cancer.

In addition, during the FDA inspection, the FDA discovered that non-serious adverse events were underreported, as the previous study coordinator was instructed by the previous staff at the Contract Research Organization that non-serious adverse events did not need to be entered on the Case Report Form. For nearly three years, this practice was followed. When the issue was identified, all the data was re-reviewed and the adverse events entered, and provided to the FDA during the application review process.