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Expectations for an International Harmonized Guideline

  • Tosiya Sato
  • Isao Yoshimura
Article

Abstract

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.

Key Words

Harmonization ICH Professional ethics Statistical guideline 

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References

  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.CrossRefGoogle 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

Copyright information

© Drug Information Association, Inc 1998

Authors and Affiliations

  • Tosiya Sato
    • 1
  • Isao Yoshimura
    • 2
  1. 1.Institute of Statistical MathematicsTokyoJapan
  2. 2.Faculty of EngineeringScience University of TokyoTokyoJapan

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