Based on the announcement about Accepting the Medical Device Oversea Clinical Trial Data Technical Guideline issued by China Food and Drug Administration (CFDA) on January 11th 2018, subjects difference is one the considerations for the CFDA oversea clinical trial data acceptance.
How will the subjects difference affect the clinical trial data?
It will be different for the mechanism, human body contacting method and time and anticipated clinical effects when medical devices working on the human body. As a result, safety impact and intervention will be different for some medical devices working on different crowds. The applicants should verify the studied population data can be extrapolated to Chinese population:
The possible influence from the subject differences:
1. Intrinsic factors: it is the influencing factors based on human genetic characteristics or demographic characteristics, including race, age, gender and etc.
2. External factors: it is the influencing factors based on social environment, natural environment and culture. It includes eating habits, religion, exposed environment, smoke, drink, disease incident, rare or endemic, obesity, treatment concept, socioeconomic status, educational status, medical compliance and etc. Also some factors listed above will be produced by both the intrinsic factors and external factors.
- Accept the Medical Device Oversea Clinical Trial Data Technical Guideline
- The Oversea Clinical Trial Data Submission Condition and Acceptance Requirements
- Technical Review Differences for The Oversea Clinical Trial Data Acceptance