Using Foreign Clinical Data
FDA's general policy
FDA may accept clinical data generated outside the USA to support premarket submissions. Acceptance depends on:
- The quality and integrity of the data (GCP compliance)
- Whether the foreign data are applicable to the US population and US medical practice
- Whether the study design meets FDA's requirements
ICH E5 — Ethnic factors in acceptance of foreign data
FDA adopted ICH E5 (Ethnic Factors in the Acceptability of Foreign Clinical Data) which provides a framework for evaluating whether foreign clinical data can be extrapolated to the US population. Key considerations:
- Intrinsic ethnic factors — genetic polymorphisms, disease characteristics
- Extrinsic ethnic factors — medical practice, diet, environment, regulatory standards
For devices, the primary considerations are whether the disease presentation, clinical practice patterns, and patient population in the foreign study are sufficiently similar to the US context.
GCP compliance is required
Foreign clinical data must be collected under conditions consistent with GCP — FDA may inspect foreign clinical sites. Data from studies that did not follow GCP may be rejected.
Practical considerations
- Use foreign data in addition to US data where possible
- Provide a clear discussion of how the foreign population is representative of the US target population
- Identify any differences in standard of care or device use between the foreign country and the USA
- Ensure that study endpoints are consistent with US regulatory expectations