Expectations for an International Harmonized Guideline
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Drug Information J o u m l , Vol. 32, pp. 135-139, 1998 Printed in the USA. All rights reserved.
EXPECTATIONS FOR AN INTERNATIONAL HARMONIZED GUIDELINE TOSIYASATO,PHD Institute of Statistical Mathematics, Tokyo, Japan
ISAO YOSHIMURA,PHD Faculty of Engineering, Science University of Tokyo, Tokyo, Japan
The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use eflcacy 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
INTRODUCTION
analysis but in all stages of clinical trials, from design to reporting. Table 1 shows the THE JAPANESE STATISTICAL guideline, literal translation of the Japanese guideline’s which is the Koseisho (the Japanese Ministry contents while Table 2 shows what each of Health and Welfare) document “Guideline chapter actually contains. for the Statistical Analysis in Clinical Trials” Chapter 2 of the Japanese statistical guide(1), went into effect in March 1992.Although line primarily covers nonstatistical issues, it covers more than statistical analysis, the and the majority of the guideline covers writtitle reflects the long-standing misundering the protocol and the summary report standing of the role of biostatistics in clinical rather than biostatistical considerations in trials in Japan. When Japanese people talk clinical trials. The notes section is very statisabout biostatistics, they mean only data analtical and technical, however, probably beysis. The authors believe that biostatisticians cause many “biostatisticians” working at should be included not only in the statistical pharmaceutical companies in Japan have neither the training nor the experience to do substantial statistical work without such dePresented at the DIA 3rd Annual BiostatisticalMeeting, tailed notes. August 27, 1996, in Tokyo, Japan. The scope of the Japanese statistical Reprint address: Tosiya Sato, Institute of Statistical guideline is described in the introduction (1): Mathematics, Minami-Azabu 4-6-7, Minato, Tokyo ‘This guideline points out mis-uses of statis106, Japan. 135
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Tosiya Sat0 and lsao Yoshimura
TABLE 1 Table of Co
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