Clinical Trials Outside the United States

FDA draft guidance released

There are many reasons why a sponsor may want to conduct a clinical trial Outside of the United States (OUS). Question is, will FDA accept this data to support marketing the device in the U.S.? Short answer, yes – provided certain conditions are met.

For a PMA, under 21 CFR 814.15(b), FDA will accept OUS clinical studies if the applicant demonstrates that the data are valid and if the clinical investigator conducted the OUS study in conformance with the 1983 Declaration of Helsinki (Declaration) or the laws and regulations of the county in which the research was conducted, whichever accords greater protection to the human subjects. If the standards of the country are used, the applicant is required to detail any differences between those standards and the Declaration and explain why they offer greater protection to the human subjects. The criteria for FDA acceptance based solely on foreign clinical data, found at 21 CFR 814.15(d), and 814.15(e), encourages sponsors to meet with FDA officials prior to submission of a PMA application.

No final rule addresses OUS data for a 510(k), HDE, or an IDE. FDA has issued a proposed rule which, when finalized, would require that foreign clinical studies in support of PMAs, IDEs, HDEs and 510(k)s be conducted in accordance with good clinical practice (GCP).

When designing an OUS clinical trial, the following should be taken into consideration.

• Differences in clinical conditions: OUS countries may have different standards of care which can affect the analysis of the benefits and risks for the studied device relative to standard practice.
• Differences in Study Populations: differences in the race, ethnicity, age, gender and sex of a foreign population can affect the applicability of the study to the intended US population. Reporting of the representation of such groups in the device submission becomes particularly important to allow appropriate sub-group analyses.
• Differences in regulatory requirements: Studies designed to satisfy the requirements of foreign countries, rather than the FDA, may not address the questions necessary not satisfy FDA requirements.

I Examples and further details can be found in the Acceptance of Medical Device Clinical Data from Studies Conducted Outside the United States.

? Email us at [email protected] if you have further questions. Ref: OUS Clinical Data