Expectations for an International Harmonized Guideline


The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use efficacy topic no. 9 Expert Working Group is developing a harmonized guideline for statistical considerations in clinical trials. The European Union, the United States, and Japan have their own separate guidelines for biostatistical issues. This paper briefly introduces the current Japanese statistical guideline, and identifies its problems: 1. Global evaluations as the primary endpoints, 2. Active control equivalence trials, and 3. Highly technical notes. Also provided are comments on multicenter trials and safety evaluations covered in the most recent guideline developed by the European Union. It is hoped that the harmonized guideline under development will foster faster clinical development of new drugs and the recognition of the necessary role of the biostatistician as a key member of a clinical research team.

This is a preview of subscription content, access via your institution.


  1. 1.

    The Japanese Ministry of Health and Welfare. Guideline for the statistical analysis in clinical trials. Tokyo, Japan: The Ministry of Health and Welfare Pharmaceutical Affairs Bureau; 1992 (in Japanese).

    Google Scholar 

  2. 2.

    CPMP Working Party on Efficacy of Medicinal Products. Biostatistical methodology in clinical trials in application for marketing authorizations for medicinal products. Stat Med. 1995;14:1659–1682.

    Article  Google Scholar 

  3. 3.

    International Statistical Institute. Declaration on professional ethics. Int Stat Rev. 1986;54:227–242.

    Google Scholar 

  4. 4.

    World Medical Association. Declaration of Helsinki. 1964, Revised 1989 in Hong Kong.

    Google Scholar 

Download references

Author information



Corresponding author

Correspondence to Tosiya Sato PhD.

Rights and permissions

Reprints and Permissions

About this article

Cite this article

Sato, T., Yoshimura, I. Expectations for an International Harmonized Guideline. Ther Innov Regul Sci 32, 135–139 (1998). https://doi.org/10.1177/009286159803200118

Download citation

Key Words

  • Harmonization
  • ICH
  • Professional ethics
  • Statistical guideline