FDA has set out its current thinking about data from clinical studies conducted outside the United States (OUS) in a draft guidance published this week. Though the agency has accepted OUS data to support approvals for years, this guidance provides more detail about factors sponsors should consider and several examples for context.
According to FDA regulation, the agency accepts OUS data from a study with U.S. sites that is carried out under an investigation device exemption (IDE) to support a premarket approval (PMA). FDA also accepts OUS studies for a PMA if the trials were conducted in accordance with the Declaration of Helsinki or the country's laws, if the country's regulations provide for stronger protection of human subjects. The Declaration of Helsinki is a set of ethical principles crafted by the World Medical Association for human medical research. If a sponsor is planning to use exclusively OUS data to try to win PMA approval for a device, they are encouraged to meet with FDA officials before making that PMA submission.
Agency rules only address OUS studies for PMA applications at this time, though there is a proposed rule from February 2013 that, if finalized, would require OUS studies in support of PMAs and other types of applications (IDEs, humanitarian device exemptions, and 510(k)s) be carried out according to good clinical practice (GCP).
Of course, the OUS data must also provide what FDA calls "valid scientific evidence" in order to support approval. The agency encourages companies to meet with agency officials as early as possible if they are planning to use OUS data for an approval application, because FDA may be able to provide feedback on trial designs and cut down on the need for additional studies.
FDA's draft guidance goes on to detail other considerations sponsors should take into account—differences in clinical conditions, study populations, and regulatory requirements. Finally, the draft guidance reviews seven different situations where OUS data was used to support FDA approval submissions. The examples portray the range of factors the agency considers and offer sponsors better insight into how FDA may view their own situation.
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