Whether Overseas Clinical Trial Data Only Can Be Accepted When Chinese Subjects Were Enrolled?

Data from Chinese subjects is not compulsory when considering if the overseas clinical trial data of a medical device is acceptable. But the administrative counterpart should confirm that the population data studied can be extrapolated to the Chinese population. According to the “Guidelines for the Acceptance of Data from Overseas Clinical Trials of Medical Devices”, the factors that may affect the results of clinical trials are not limited to ethnic differences. The factors of differences in the population and the conditions of clinical trials need to be comprehensively considered based on product characteristics. Although it is already known that such factors exist objectively and may have some influence on the clinical trial, the influence degree of such factors shall be judged in combination with the characteristics of the medical device under application and the purpose of the clinical trial. When it is determined that such factors have no actual clinically significant influence on the clinical trial data of most medical devices according to the development status, the experience in clinical application as well as the cognition of related diseases and diagnosis and treatment methods, it is not required to prove them one by one. When it is determined that or it is hard to determine whether some factors have clinically significant influence on the clinical trial data, the applicant shall explain the methods taken to reduce or eliminate the influence of each difference. For example, administrative counterpart may consider to conduct subgroup design for the subjects or conduct subgroup analysis for the existing clinical trial data as needed.