University of Texas Clinical Trial Issues

A 12/3-12/6/2024 FDA Bioresearch Monitoring Program inspection involving two clinical trial protocols at the University of Texas Health Science Center at San Antonio, with Dr. Ralph DeFronzo as clinical investigator, found “objectionable conditions” and a failure to follow the law and regulations governing the conduct of clinical investigations and the protection of human subjects. A 9/17 Warning Letter says the specific violations were:

• failure to ensure that the investigation was conducted according to the investigational plan; and
• failure to promptly report all changes in research activity to the institutional review board.

For each item, FDA acknowledges the corrective actions DeFronzo has taken, but says his responses were inadequate.

DeFronzo was told to respond with a list of specific actions he has taken to prevent similar violations in the future.