FDA attempting to simplify process for medical device makers to use foreign clinical trial data

Many medical device clinical trials occur at sites outside of the U.S., but it can be challenging to apply that data stateside thanks to regulatory inconsistencies with the FDA. The new document outlines the standards the FDA expects from clinical studies conducted outside the U.S. – so as to promote consistency in trial design while protecting trial subjects, RAPS […]

By Meghana Keshavan on April 21, 2015 7:32 pm

Many medical device clinical trials occur at sites outside of the U.S., but it can be challenging to apply that data stateside thanks to regulatory inconsistencies with the FDA.

The new document outlines the standards the FDA expects from clinical studies conducted outside the U.S. – so as to promote consistency in trial design while protecting trial subjects, RAPS points out. It’s not a policy change, mind you – just an indicator of what the FDA expects.

The FDA document concedes that the number of U.S. IDE applications for marketing authorization has grown, and will likely continue to increase in the future.

“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.”

RAPS outlines FDA’s changed view on regulating foreign medical device clinical trials:

Either a company’s clinical trials conducted outside the US exactly meet federal human subject protection requirements, or they meet local standards, which a company must show are either equal to or greater than US requirements for human protection under the 1983 version of the Declaration of Helsinki.

In addition, FDA’s guidance addressed what it calls “valid scientific evidence”—evidence from what FDA defines 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.”

The FDA wants sponsors to note whether clinical conditions impacting a patient’s health differ from the U.S.; whether the populations are too different to compare to U.S. patients, and whether a country’s regulatory environment may differ enough from the U.S. to not stand up to FDA standards, RAPS says.