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

verfasst von

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.

Organisationseinheit(en)

Abteilung Biostatistik

Externe Organisation(en)

Meisei University

Typ

Artikel

Journal

Therapeutic Innovation & Regulatory Science

Band

37

Seiten

381-395

Anzahl der Seiten

15

ISSN

2168-4790

Publikationsdatum

01.10.2003

Publikationsstatus

Veröffentlicht

Peer-reviewed

Ja

ASJC Scopus Sachgebiete

Pharmakologie, Toxikologie und Pharmazie (sonstige), Öffentliche Gesundheit, Umwelt- und Arbeitsmedizin, Pharmakologie (medizinische)

Ziele für nachhaltige Entwicklung

SDG 3 – Gute Gesundheit und Wohlergehen

Elektronische Version(en)

https://doi.org/10.1177/009286150303700405 (Zugang: Geschlossen)
https://doi.org/10.15488/3012 (Zugang: Offen)