Advertisement

Expectations for an International Harmonized Guideline

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.

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

Access options

Buy single article

Instant unlimited access to the full article PDF.

US$ 39.95

Price includes VAT for USA

Subscribe to journal

Immediate online access to all issues from 2019. Subscription will auto renew annually.

US$ 189

This is the net price. Taxes to be calculated in checkout.

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).

  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.

  3. 3.

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

  4. 4.

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

Download references

Author information

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) doi:10.1177/009286159803200118

Download citation

Key Words

  • Harmonization
  • ICH
  • Professional ethics
  • Statistical guideline