FDA is looking to make it easier for device makers to use foreign clinical trial data. The agency has issued a new document (PDF link) outlining the standards it expects from clinical studies conducted outside the U.S. It’s not a policy change, but an indicator of what the FDA expects.

“This increasing globalization of clinical trials presents challenges to both US and foreign regulators,” the FDA guidance document says. “Among the challenges are resource constraints that impact the number of foreign clinical site inspections and unnecessary duplication of clinical studies and administrative burdens.”

The FDA wants that medical device clinical trials conducted outside of the US are either equal to or greater than US requirements for human protection under the 1983 version of the Declaration of Helsinki.

Additionally, the new guidance addresses the so called “valid scientific evidence” which is defined as “well-controlled investigations, partially controlled studies, studies and objective trials without matched controls, well-documents case histories conducted by qualified experts and reports of significant human experience with a marketed device.”

Finally, FDA wants sponsors to note whether clinical conditions impacting a patient’s health differ from the US, whether the populations are too different to compare to US patients, and whether a country’s regulatory environment doesn’t meet FDA standards.

[Via: MedCityNews, RAPS]