The Department of Health and Human Services Office of Inspector General (OIG) said the FDA needs to “improve its system for overseeing foreign clinical trials” in a report released June 22.
The FDA agreed with the OIG’s three recommendations to:
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require standardized electronic clinical trial data and create an internal database;
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monitor trends in foreign clinical trials not conducted under investigational new drug (IND) applications and if necessary take steps to encourage sponsors to file INDs; and
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explore ways to expand its oversight of foreign clinical trials by continuing to develop inspectional agreements with foreign regulatory bodies, inspecting trials in more countries, and exploring new models of oversight.
In a response to the report, Joshua Sharfstein, FDA’s principal deputy commissioner, said “the agency either has ongoing efforts that will address the recommendations or has initiated development of new procedures that will incorporate the recommendations.” However, he noted that “under FDA’s existing statutory authority, the agency cannot require sponsors to file an IND for studies conducted outside the United States. In its oversight activities of clinical trials, the agency must also be respectful of the sovereignty of individual countries and consider the role of national regulatory authorities.”
More on the OIG report and FDA response will be in the August issue of the Guide to Good Clinical Practice.
