The conduct of clinical trials in Japan has changed with the implementation of the International Conference on Harmonization and Good Clinical Practice (GCP) guidelines in 1997. Even though the primary objective of the guidelines is to maintain the quality of trials at an internationally acceptable level, the implementation of the guidelines has had another critical impact on Japanese clinical trials.
These guidelines have introduced ‘market’ components that could ignite competition among research institutions and investigators for the first time in Japan. It is anticipated that increasing competition might lead to improved efficiency in terms of creation of clinical evidence in society. However, there are a couple of local features of the Japanese trial market that make such competition fairly unlikely. These features include price controls for trial contracts and other bureaucracy in the public sectors. The Ministry of Health, Labor and Welfare in Japan established national clinical trial networks in 2003, to boost domestic research activities. Irrespective of the intention of the government, it is possible that these new gigantic players could harm the burgeoning trend of competition in Japan.
The implementation of internationally harmonized GCP guidelines and its consequences, including the recent emergence of important Western components of clinical trials such as clinical research coordinators and independent institutional review boards, indicate that Japanese trials are becoming closer, at least on the surface, to those in the US or European Union. However it is important to notice at the same time that the mechanism and components of competition (e.g. price as a signal of willingness to pay), on which Western research activities are more or less based, have been cautiously repudiated in Japan. International harmonization in clinical development activities should be promoted further in consideration of this critical difference in the environment.
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The views and opinions expressed in this article are not those of the Ministry of Health, Labor and Welfare, nor those of any specific organization. No sources of funding were used to assist in the preparation of this manuscript. The authors have no conflicts of interest that are directly relevant to the content of this manuscript.
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Ono, S., Tsutani, K., Shibata, T. et al. Clinical Trials in Japan After Implementation of the International Conference on Harmonization — Good Clinical Practice (ICH-GCP) Guidelines. Pharm Dev Regul 1, 81–89 (2003). https://doi.org/10.1007/BF03257368
- European Union
- Good Clinical Practice Guideline
- Pharmaceutical Firm
- Japanese Trial
- Commercial Trial