Module 1 2021
28/06/2021
Basic Principles of Global Clinical Trials in Japan
Clinical trial consultations should be done as early as possible.
Before the start of the clinical trial, it is required to examine single dose safety and PK in Japanese healthy patients to confirm the risks in Japanese are equivalent to non- Japanese.
It is recommended to include Japanese patients into a dose-finding study to identify inter-ethnic difference in dose- response relationship
Distribution to third parties is not allowed
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Basic Principles of Global Clinical Trials in Japan
Basic points to consider in designing a global clinical trial
It is necessary to evaluate effects of ethnic factors, efficacy and safety of investigational drugs in Japanese
Designs and analytical methods for the global clinical trial should be acceptable to Japan
The primary endpoints should be those acceptable to all individual regions.
To allow for appropriate safety evaluation, the collecting and assessing method of adverse event information should be standardized as much as possible across all regions
Distribution to third parties is not allowed
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