FDA EIR - Rogerio Lobo - June 25, 2013

An FDA inspection of Dr. Rogerio A. Lobo, affiliated with Columbia University Medical Center, occurred from June 5 to June 25, 2013. This initial inspection focused on Dr. Lobo's role as sponsor for an Investigational New Drug (IND) study involving Clomiphene (Clomid). The investigation stemmed from Columbia University Medical Center's Institutional Review Board (IRB) concerns regarding subject consent processes and adherence to the approved protocol.

The inspection revealed significant departures from good clinical practice. As the study sponsor, Dr. Lobo failed to review safety and effectiveness data, did not appoint a monitor to oversee investigator compliance, and neglected to ensure the selection of appropriately qualified clinical investigators. Further issues included a lack of control over the investigational drug, the absence of an original Statement of Investigator (FD-1572), and inadequate provisions for collecting and reporting adverse experiences, with two subjects experiencing unreported adverse events. Additionally, the Data Safety Monitoring Board did not fulfill its protocol-defined obligations for timely reviews and meetings. The principal investigator for the study also displayed numerous failures, such as enrolling subjects during a period of IRB non-approval and obtaining improper informed consents.

These observations were formally documented on an FD-483. Dr. Lobo provided a written response on July 15, 2013, detailing corrective measures, which the FDA found adequate. In parallel, Columbia University's Department of Obstetrics and Gynecology implemented new policies to enhance future clinical research compliance, including mandatory pre-IRB review by the department Chairman, quarterly study monitoring, monthly training, and requiring trained study coordinators for all research physicians.