Advertisement

Springer Nature is making SARS-CoV-2 and COVID-19 research free. View research | View latest news | Sign up for updates

Clinical Trials in Japan After Implementation of the International Conference on Harmonization — Good Clinical Practice (ICH-GCP) Guidelines

Increasing Westernization?

  • 5 Accesses

Abstract

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.

This is a preview of subscription content, log in to check access.

Fig. 1
Table I
Fig. 2
Table II

References

  1. 1.

    Ono S, Kodama Y. Clinical trials and the new good clinical practice guideline in Japan. Pharmacoeconomics 2000; 18(2): 125–41

  2. 2.

    Ninomiya K. SMOs in the US: working group for developing a standard guidance for SMOs. Tokyo: Ministry of Health, Labor and Welfare, 2002 May 22

  3. 3.

    Hirohara M, Uezuka Y, Katsuura K. Analysis of the balance between costs and revenues of trial management activities [in Japanese]. Jpn J Clin Pharmacol Ther 2002; 33(2): 445–6S

  4. 4.

    National Institute of Health Sciences. Trends in investigational new drug applications (2002) [in Japanese]. Available from URL: http://www.nihs.go.jp [Accessed 2003 Apr 3]

  5. 5.

    Ninomiya K. SMOs in the US. Working group for developing a standard guidance for SMOs. Tokyo: Ministry of Health, Labor and Welfare. 2002 May 22

  6. 6.

    Report on clinical trials in South Africa [in Japanese]. Nikkan Yakugyo 2002 Apr 30; 7

  7. 7.

    Pharmaceutical Research and Manufacturers of America (PhRMA). Domestic R&D by function. Pharmaceutical Industry Profile 2002. Available from URL: http://www.phrma.org [Assessed 2002 Dec 2]

  8. 8.

    Fukahara S, Tababe N, Sato K, et al. Good clinical practice in Japan before and after ICH. Int J Pharm Med 1997; 11: 147–53

  9. 9.

    International Conference on Harmonization. Ethnic factors in the acceptability of foreign clinical data (E5). Available from URL: http://www.ich.org [Accessed 2003 Apr 3]

  10. 10.

    Abe S. Clinical trial in Japan — from the inspector’s aspect [in Japanese]. In: Nakano S, editor. Points of clinical pharmacology. Tokyo: Life Science Publishing, 1998: 83–94

  11. 11.

    Recent trends in clinical trials in Japan [in Japanese]. Monthly Mix 1997 Jul, 44–66

  12. 12.

    Recent trends in clinical trials in Japan (part 3) [in Japanese]. Monthly MIX 1998 Sep, 44–65

  13. 13.

    Ferris M, Uden S, Iwasaaki M, et al. Drug development in Asia. Proceedings of the 2nd Asia-Pacific Economic Cooperation workshop on bridging study; 2002 Sep 18; Tokyo, 38–42

  14. 14.

    Takahashi Y. Prospect of clinical trials from SMO’s perspective [in Japanese]. Jpn J Clin Pharmacol Ther 2001; 32(3): 521–S

  15. 15.

    Ono S, Kodama Y, Nagao T. Infrastructure of pharmaceutical research and development in Japan. Ann Pharmacother 2001; 35: 1122–9

  16. 16.

    Ministry of Health, Labor and Welfare. Materials for Working Group for developing a large trial network (June 2002). Available from URL: http://mhlw.go.jp [Assessed 2002 Jul 11]

  17. 17.

    Ministry of Health, Labor and Welfare. Outline of regulations on investigator-initiated trials [in Japanese]. Available from URL: http://www.mhlw.go.jp [Accessed 2003 Apr 3]

  18. 18.

    Ministry of Health, Labor and Welfare. Regarding the amendments of the Medical Law (Notification No. 125, 2001 Feb 22) [in Japanese]. Available from URL: http://wwwhoueri.mhlw.go.jp [Accessed 2002 Apr 3]

  19. 19.

    Hirai A, Ito Y, Ito K, et al. A digital network for clinical trials involving multiple private clinics in Japan. Drug Inf J 2001; 35: 497–500

  20. 20.

    Ono S, Kodama Y, Nagao T, et al. The quality of conduct in Japanese clinical trials: deficiencies found in GCP inspections. Control Clin Trials 2002; 23: 29–41

  21. 21.

    Ichikawa S, Tamaki M. Critical changes in clinical trials in Japan. Drug Inf J 2001; 35: 493–5

  22. 22.

    Kamiya A, Furukawa H, Hasegawa M, et al. Surveillance on the background of Japanese clinical trials. [in Japanese]. Jpn J Clin Pharmacol Ther 2001; 32(2): 355–6S

  23. 23.

    Giulio PD, Arrigo C, Gall H, et al. Expanding the role of the nurse in clinical trials: the nursing summaries. Cancer Nurs 1996; 19(5): 343–7

  24. 24.

    The role of independent institutional review boards (IRBs) in multi-center trials in the United States [in Japanese]. Yakuji Nippo 2001 Dec 7; 16

  25. 25.

    Saito H. Responses to questionnaires on subject recruitment. Monthly MIX 2001 Feb, 53–8

  26. 26.

    Kjaergard LL, Villumsen J, Gluud C. Reported methodologic quality and discrepancies between large and small randomized trials in meta-analyses. Ann Intern Med 2001; 135: 982–9

  27. 27.

    Funds from drug firms handled as tax-exempt [in Japanese]. Yomiuri Shimbun 2001 Dec 10, 19

Download references

Acknowledgements

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.

Author information

Correspondence to Dr Shunsuke Ono.

Rights and permissions

Reprints and Permissions

About this article

Cite this article

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

Download citation

Keywords

  • European Union
  • Good Clinical Practice Guideline
  • Pharmaceutical Firm
  • Japanese Trial
  • Commercial Trial