Impact of the ICH E9 Guideline Statistical Principles for Clinical Trials on the Conduct of Clinical Trials in Japan

authored by

Chihiro Hirotsu, Ludwig A. Hothorn

Abstract

This article evaluates the impact of the ICH E9 guideline Statistical Principles for Clinical Trials on the conduct of clinical trials in Japan. In particular, the following Japanese practices in the conduct of clinical trials are discussed in detail from the ethical, statistical, and logical viewpoints: 1. Conducting only one phase 3 multicenter trial with many centers and few subjects per center; 2. Seeking to show noninferiority to an active control rather than superiority to placebo; and 3. Choosing a global assessment variable with a subjective component as the primary endpoint. The influence of public health insurance and the potential number of patients in Japan on various aspects of a trial are discussed. Problems requiring further research are mentioned and points requiring clarification are highlighted.

Organisation(s)

Department of Biostatistics

External Organisation(s)

Meisei University

Type

Article

Journal

Therapeutic Innovation & Regulatory Science

Volume

37

Pages

381-395

No. of pages

15

ISSN

2168-4790

Publication date

01.10.2003

Publication status

Published

Peer reviewed

Yes

ASJC Scopus subject areas

Pharmacology, Toxicology and Pharmaceutics (miscellaneous), Public Health, Environmental and Occupational Health, Pharmacology (medical)

Sustainable Development Goals

SDG 3 - Good Health and Well-being

Electronic version(s)

https://doi.org/10.1177/009286150303700405 (Access: Closed)
https://doi.org/10.15488/3012 (Access: Open)