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Clinical Trials and the New Good Clinical Practice Guideline in Japan

An Economic Perspective

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Abstract

Japanese clinical trials have been drastically changing in response to the implementation of the International Conference on Harmonisation — Good Clinical Practice (ICH-GCP) guideline in 1997. The most important aim of the new guideline is to standardise the quality of clinical trials in the US, European Union and Japan, but it inevitably imposes substantial costs on investigators, sponsors and even patients in Japan.

The study environment in Japan differs from that in the US in several ways: (i) historical lack of a formal requirement for informed consent; (ii) patients’ attitudes to clinical trials in terms of expectation of positive outcomes; (iii) the implications of universal health insurance for trial participation; (iv) the historical absence of on-site monitoring by the sponsor, with the attendant effects on study quality; and (v) the lack of adequate financial and personnel support for the conduct of trials. Implementation of the new GCP guideline will improve the ethical and scientific quality of trials conducted in Japan. It may also lead to an improved relationship between medical professionals and patients if the requirement for explicit informed consent in clinical trials leads to the provision of a similar level of patient information in routine care and changes the traditional paternalistic attitude of physicians to patients.

The initial response of the Japanese ‘market’ for clinical trials to the implementation of the ICH-GCP guideline has been clinical trial price increases and a decrease in the number of study contracts. These changes can be explained by applying a simple demand-supply scheme. Whether clinical trials undertaken in Japan become more or less attractive to the industry in the long term will depend on other factors such as international regulations on the acceptability of foreign clinical trials and the reform of domestic healthcare policies.

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Acknowledgements

The opinions and views expressed in this article are of those of the authors and not of the Ministry of Health and Welfare in Japan. We are grateful to Mr Thomas Long for his assistance.

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Authors and Affiliations

  1. Pharmaceuticals and Medical Devices Evaluation Center, National Institute of Health Sciences, Ministry of Health and Welfare, 3-8-21 Toranomon, Minato-ku, Tokyo, 100-8409, Japan

    Shunsuke Ono

  2. Review and Audit Division, Clinical Trial Guidance Department, The Organisation for Pharmaceutical Safety and Research, Tokyo, Japan

    Yasuo Kodama

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  1. Shunsuke Ono
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  2. Yasuo Kodama
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Correspondence to Shunsuke Ono.

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Ono, S., Kodama, Y. Clinical Trials and the New Good Clinical Practice Guideline in Japan. Pharmacoeconomics 18, 125–141 (2000). https://doi.org/10.2165/00019053-200018020-00003

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