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Activity Number:
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547
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Type:
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Topic Contributed
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Date/Time:
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Thursday, August 6, 2009 : 8:30 AM to 10:20 AM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #305151 |
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Title:
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Issues in Evaluating Multiregional Clinical Trials
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Author(s):
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Yuki Ando*+
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Companies:
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Pharmaceuticals and Medical Devices Agency
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Address:
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3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo, 100-0013, Japan
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Keywords:
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multi-regional clinical trial ; new drug application ; ethnic factor
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Abstract:
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Since many Japanese pharmaceutical companies plan to use data from multi-regional clinical trials including Japanese patients for their new drug application (NDA) recently, the number of NDA with multi-regional clinical trials will rapidly increase in the near future. Based on PMDA's review experiences, it is sometimes difficult to conclude that a recommended dose in other region is also a recommended dose for Japanese, and confirmatory studies may have different results between regions even if they are according to almost the same protocol. Therefore it is necessary to evaluate effects of ethnic factors on efficacy and safety of investigational drugs when reviewing NDA with multi-regional clinical trials. In this presentation, recent issues in evaluating multi-regional clinical trials raised in Japan will be reviewed.
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