The US Food and Drug Administration (FDA) issued a draft guidance for industry this month entitled ‘Acceptance of Medical Device Clinical Data from Studies Conducted Outside the United States’. The draft guidance expresses the FDA’s policy of accepting scientifically valid clinical data from foreign clinical studies in support of premarket submissions for devices. The guidance describes special considerations that apply when relying on clinical data from foreign studies. These include:
- Differences in clinical conditions – countries outside of the US may have different standards of care which may affect the analysis of the benefits and risks of the studied device relative to standard practice. Differences in clinical facilities and levels of clinical skill can also affect study data from outside the US to the extent that such data may not be generalised to US clinical practice and the differences could impact the data’s usefulness in supporting the safety and/or effectiveness of the device.
- Differences in study populations – differences in the race, ethnicity, age and gender of a foreign population can affect the applicability of the study to the intended US population. The foreign studied population and the intended US patient populations may also differ in the prevalence of confounding clinical factors that can affect risks of an intervention as well as clinical response. For example, populations vary widely in the prevalence of smoking, diabetes and obesity, and rare or regionalised co-morbidities occur in certain populations that can confound study results.
- Differences in regulatory requirements – when studies conducted outside the US are initiated to satisfy the requirements of foreign countries, rather than, or in addition to FDA the studies may not be designed to address the questions necessary to satisfy FDA requirements.
Valid scientific evidence is only one factor in determining whether FDA can use the data to support a decision on premarket submission but does not generally address ethical considerations. In 2013, FDA proposed a rule – ‘Human Subject Protection: Acceptance of Data from Clinical Studies for Medical Devices’ – which requires that clinical studies conducted outside the US in support for premarket submissions be conducted in accordance with good clinical practice. The proposed rule, when finalised, is intended to help ensure the protection of human subjects and the quality and integrity of the data obtained from these studies.