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OIG addresses FDA oversight of clinical trials

Device Regulation Alert: Safety, Compliance and Reimbursement News, October 22, 2007

An OIG report concludes the FDA needs to improve how it identifies clinical trials and institutional review boards (IRBs) and how it tracks FDA inspection of clinical trials.

The report noted the FDA doesn't have registries listing all clinical trials and IRBs. Therefore it can't identify all trials, trial sites, and IRBs. The OIG also criticized the FDA's tracking of trials, noting the lack of a uniform method to track inspection information.

The 2007 report recommends the FDA improve oversight of clinical trials by:

• creating an FDA database of all clinical trials
• establishing a registry for IRBs
• developing a database to track FDA inspections
• expanding FDA authority so oversight of clinical trials reflects how the trials are truly run-for example, seeking to include review of colleagues of the clinical investigator when they participate in a trial
• improving communication and feedback on inspection reports and findings

Click here to view the inspection report.

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