The majority of clinical trials used to support drug approvals in America are being conducted outside of the US, where inspection is rare and standards may be lax.

A new report from the Department of Health and Human Services Office of Inspector General reveals that, for drugs approved in 2008, 80% of applications for approval contained data from foreign clinical trials and over half of the subjects in trials were located outside the US, most in Western Europe (report, pdf).

The report is heightening concerns about the ever increasing move of trials into countries where costs are lower and regulation is seen as lighter. Central and South America, Eastern Europe and Asia also account for a significant number of clinical trials identified in the report.

“As sponsors increase the number of foreign clinical trials in support of FDA marketing applications, the agency’s current method of using inspections to ensure human subject protections and data validity is becoming increasingly strained,” warns the report.

While the Food and Drug Administration, which approves medicines in the US, inspected 1.9% of domestic clinical trials, it checked up on only 0.7% of foreign trials (see table). The FDA conducted no inspections at all in 10 countries that between them accounted for nearly 50,000 clinical trial patients.

Democratic Rep Rosa DeLauro told the New York Times that the report, “highlights a very frightening and appalling situation”.

She added, “By pursuing clinical trials in foreign countries with lower standards and where FDA lacks oversight, the industry is seeking the path of least resistance toward lower costs and higher profits to the detriment of public health.”

Ken Johnson, senior vice president of the Pharmaceutical Research and Manufacturers of America, denied that there was anything untoward in the use of foreign clinical trials. “The same strict regulatory standards apply to foreign trials as trials conducted domestically,” he said in a statement.

The report makes a number of recommendations for increased oversight – including that the FDA inspect more foreign trials and develop “inspectional agreements” foreign regulators. The Agency says it agrees with the recommendations and either already has efforts in place to address them or is developing such procedures.