Challenges to FDA’s Ability To Monitor and Inspect Foreign Clinical Trials

In fiscal year 2008,  80 percent of approved marketing applications for drugs and biologics contained data from foreign clinical trials. Over half of clinical trial subjects and sites were located outside the United States. 

This poses major challenges to the US Food and Drug Administration (FDA) in monitoring and inspecting clinical trials worldwide.
Report’s findings include the following:

•  FDA should require standardized electronic clinical trial data and create an internal database
• FDA should monitor trends in foreign clinical trials not conducted under INDs.
• FDA should continue to explore ways to expand its oversight of clinical foreign trials.

A related news item may be found here. 

The complete report may be found here.