More than three quarters of all clinical trial subjects were enrolled overseas, and yet the FDA inspected just 45 foreign investigative sites in 2008. That’s just 0.7% of all overseas sites that enrolled a trial subject.
This is according to a new report from the U.S. Department of Health and Human Services’ Office of Inspector General (OIG). The report, “Challenges to FDA’s Ability to Monitor and Inspect Foreign Clinical Trials,” looked at the 129 marketing applications for drugs and biologics approved by the U.S. Food and Drug Administration (FDA) in fiscal 2008. It revealed that sites were inspected in only 20 of the 72 countries identified in the OIG review of marketing applications, and that some of the countries not inspected enrolled significant numbers of subjects (for example: Peru, with 13,628; Columbia, with 5,480; and Chile with 4,949). Almost 78% of the 299,701 subjects recruited for clinical trials in 2008 were enrolled at sites outside the U.S.
But the problem is not just overseas: the FDA inspected just 102 U.S. sites in 2008, which constituted 1.9% of the U.S. total. So, though inspection of overseas sites is low, inspection of U.S. sites is low, too.
The reason is lack of resources, said Christine Pierre, president of 16-year-old site network RxTrials.
“This is a critical branch of government that is responsible for overseeing clinical research and they want to be accountable, but they can only do so much with the limited resources they have,” Pierre said. “Now that it has been established that we’re truly going to be a global industry, we must empower the agency with not only the proper relationships in these countries but also the resources to execute inspections appropriately.”
Pierre added that she hopes the report will serve to engender public support for more FDA funding so it can increase oversight of investigative sites both here and abroad.
In the report, the OIG suggested that the FDA require sponsors to submit clinical trial data in a standardized electronic format so that FDA reviewers can better analyze it. From there, the FDA could create an internal database for culling trial data and thus could better choose sites for inspection. In addition, the OIG suggested stepping up inspection of sites in countries where adoption of Good Clinical Practice standards is new.
Watching the industry scramble to go overseas has Tracy Blumenfeld, CEO of RapidTrials, shaking her head. Rapid-Trials helps U.S. investigative sites improve their operations.
“If all the money, time and effort that’s been invested in figuring out how to run global clinical research had been invested in sites in the U.S., we would have achieved significant improvements in the model here, and sponsors would have gotten the same impact economically,” Blumenfeld said.