Details
| Original language | English |
|---|---|
| Pages (from-to) | 381-395 |
| Number of pages | 15 |
| Journal | Therapeutic Innovation & Regulatory Science |
| Volume | 37 |
| Issue number | 4 |
| Publication status | Published - 1 Oct 2003 |
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.
Keywords
- Noninferiority trial, Random and fixed effects models for centers, Subjective and objective measures
ASJC Scopus subject areas
- Pharmacology, Toxicology and Pharmaceutics(all)
- Pharmacology, Toxicology and Pharmaceutics (miscellaneous)
- Medicine(all)
- Public Health, Environmental and Occupational Health
- Medicine(all)
- Pharmacology (medical)
Sustainable Development Goals
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In: Therapeutic Innovation & Regulatory Science, Vol. 37, No. 4, 01.10.2003, p. 381-395.
Research output: Contribution to journal › Article › Research › peer review
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TY - JOUR
T1 - Impact of the ICH E9 Guideline Statistical Principles for Clinical Trials on the Conduct of Clinical Trials in Japan
AU - Hirotsu, Chihiro
AU - Hothorn, Ludwig A.
PY - 2003/10/1
Y1 - 2003/10/1
N2 - 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.
AB - 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.
KW - Noninferiority trial
KW - Random and fixed effects models for centers
KW - Subjective and objective measures
UR - http://www.scopus.com/inward/record.url?scp=84993708191&partnerID=8YFLogxK
U2 - 10.1177/009286150303700405
DO - 10.1177/009286150303700405
M3 - Article
AN - SCOPUS:84993708191
VL - 37
SP - 381
EP - 395
JO - Therapeutic Innovation & Regulatory Science
JF - Therapeutic Innovation & Regulatory Science
SN - 2168-4790
IS - 4
ER -