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OIG releases report on FDA's oversight of clinical trials

Pharma Compliance Alert, October 3, 2007

The FDA's ability to oversee clinical trial inspections is hindered by weakness in its information systems and management processes, according to a report by the Office of Inspector General (OIG).

The OIG report focused on the FDA's Bioresearch Monitoring Program, which is designed to protect human subjects once a clinical trial begins.

According to the OIG, the FDA "does not have a mechanism to identify all clinical trials and institutional review boards (IRBs), which approve, monitor, and review research involving human subjects." The report also cites the lack of a comprehensive database to track inspections of clinical trials.

The OIG identified the following steps the FDA could take to improve its system for overseeing clinical trials:

• Develop a comprehensive internal database of all clinical trials
• Create a registry of IRBs
• Create a cross-center database that allows complete tracking of FDA inspections
• Seek legal authority to provide oversight that reflects current clinical trial practices
• Establish a mechanism to provide feedback to FDA district office staff on their inspection reports and findings.

Click here to read the press release. To read the full report, click here.

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