Statistical Approaches to Accepting Foreign Clinical Data
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Drug Information Journal, Vol. 34, pp. 1265-1272, 2000 Printed in the USA. All rights reserved.
STATISTICAL APPROACHES TO ACCEPTING FOREIGN CLINICAL DATA NORISUKEKAWAI Biostatistics & Data Management Group, Clinical Development Coordination Department, Yamanouchi Pharmaceutical Co., Ltd., Tokyo, Japan
MASAKAZUANDOH Biostatistics & Data Management Group, Clinical Development Coordmation Department, Yamanouchi Pharmaceutical Co., Ltd., Tokyo, Japan
TOHRUUWOI Strategic Marketing Research Department, Sales & Marketing Division, Yamanouchi Pharmaceutical Co., Ltd., Tokyo, Japan
MASASHIGOTO,PHD Division of Statistical Science, Graduate School of Engineering Sciences, Osaka University, Osaka, Japan
In this paper; we discuss two issues about bridging studies described in the Interrlational Conference on Harmonization (ICH)E5 guideline. One of the issues is the basic concept of accepting foreign clinical data by performing bridging studies. The guideline does not mention why foreign data can be extrapolated to a new region through bridging studies. We introduce an “analogy” to clarify this. Another issue is the statistical approaches used to show the similarity between foreign data and the new region’s data in a bridging study. We consider two cases: foreign a’ata to show similarity that consist of one study or many studies. Key Words: Bridging study; Analogy; Similarity
INTRODUCTION THE ICH-E5 GUIDELINE “Ethnic Factors in the Acceptability of Foreign Clinical Data” reached Step 4 on February 5, 1998 (1). The intention of the guideline is to facilitate the registration of medicines among ICH regions (United States, European Union, and Japan)
Presented at the DIA 35th Annual Meeting, June 27July I , 1999, Baltimore, Maryland. Reprint address: Norisuke Kawai, Biostatistics & Data Management Group, Clinical Development Coordination Dept., Yamanouchi Pharmaceutical Co., Lid., 17-1, Hasune 3-chome Itabashi-ku, Tokyo 174-8612 Japan. E-mail: [email protected].
by recommending a framework for evaluating the impact of ethnic factors upon medicines’ effects while minimizing duplication of clinical studies and supplying medicines expeditiously to patients for their benefit. One of the main topics described in the guideline is the bridging study. A bridging study is defined as a supplemental study performed in the new region to provide pharmacokinetic/pharmacodynamic or clinical data on efficacy, safety, dosage, and dose regimen in the new region. Such a study will allow Of the foreign data to the new region. The guideline further mentions that: “If the bridging study shows that dose-response, safety, and efficacy in the new
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Norisuke Kawai, Masakazu Andoh, Tohru Uwoi, and Masashi Goto
region are similar, then the study is readily to show the similarity consist of one study interpreted as capable of bridging the foreign or many studies. data.” The guideline impacted drug development CONCEPT OF THE BRIDGING strategies in the
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