Abstract:

The conduction of clinical trials initiates in 1750's whereas the original concept is derived from the contents of the Hebrew Bible. In 1964, Declaration of Helsinki was formed to provide ethical rules for conducting human experimentation, which is considered as cornerstone principles for clinical trial conduction nowadays. To meet the global need for international human health care, such as the challenge brought by widespread infectious disease, multinational clinical trial rather than local clinical studies are performed among national/university medical centers.

The paper would start with the historical incentives of performing multinational clinical studies. Compared to local clinical studies, different aspects of moral and ethical concerns for conducting multinational clinical trials would be analyzed. Several collaboration schemes among University medical centers in Asia, Europe and America are demonstrated and corresponding educational frameworks are compared. In conclusion, racial and cultural factors may result in deviating variables in multinational clinical trial. Furthermore, a well-sounded University medical center educational scheme with transparent information exchange and proof-of-concept adoption between Institution Review Board and University Medical Center would not only benefit the international perspective of clinical design but also conform with the Declaration of Helsinki and ICH guideline to achieve robust medical data and Good Clinical Practice.

Keywords:

Clinical Studies, Good Clinical Practice, Declaration of Helsinki, Institution Review Board.