OIG Report: FDA needs to improve clinical trial methods

Weaknesses in the FDA’s information systems and management processes are hindering the agency’s ability to oversee clinical trial inspections were the findings of a recent report by the Office of the Inspector General (OIG) of the Department of Health and Human Services.

Federal law requires that new drugs and medical devices undergo clinical trials to demonstrate their safety and efficacy prior to receiving FDA approval. The agency inspects clinical trials to determine whether sponsors, clinical investigators and institutional review boards of the trials are complying with regulations.

The 41-page report, “FDA’s Oversight of Clinical Trials,” said the FDA only has 200 specially-trained inspectors to audit an estimated 350,000 investigative sites. The report also found that federal health officials did not know how many clinical trials were being conducted in the United States.

In the report, the OIG said that “We recognize the important role that FDA’s protocol review plays in protecting human subjects and made several changes to our report to reflect this point. We do note, however, that this report addresses another important part of the system for protecting human subjects: oversight of the trials once they are actually underway.”

For instance, the report stated that when overburdened inspectors found serious problems in clinical trials, their superiors in Washington downgraded their findings 68 percent of the time.

The OIG identified five steps that could be taken to improve its system of oversight:

• Develop a comprehensive internal database of all clinical trials;
• Create a registry of Institutional Review Boards (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; and
• Establish a forum to provide feedback to FDA staff on their reports and findings.