FDA EIR - James N Allen MD - March 01, 2010

An FDA inspection of Clinical Investigator James N. Allen, M.D., in Columbus, OH, occurred from February 8 to March 1, 2010. The high-priority inspection, covering a clinical study of Pirfenidone, was conducted under the regulatory guidance of CP 7348.811, "Bioresearch Monitoring-Clinical Investigations," and aimed at data validation. The inspection resulted in an FD-483 (Inspectional Observations) citing two main issues. First, Dr. Allen failed to maintain accurate case histories, evidenced by significant discrepancies between subject source documentation and Case Report Forms (CRFs) across multiple subjects regarding various data points such as patient ratings, laboratory results, and study drug accountability, violating 21CFR312.62(b). Second, the investigation did not adhere to the investigational plan due to the under-reporting of adverse events to the study sponsor, a breach of 21CFR312.60. An example included a worsening cough noted in a patient diary that was later removed from the CRF without clear justification. Additionally, the non-reporting of Serious Adverse Events (SAEs) to the Institutional Review Board (IRB) was a significant point of discussion, though not formally cited. Dr. Allen maintained that these SAEs did not meet the IRB's specific reporting criteria. In response, Dr. Allen acknowledged the transcription errors, attributing them to data organization differences. He committed to aligning source documents and CRFs better in future studies and establishing an internal peer audit process for CRFs. He was expected to provide a written response to the FD-483.