Module 5 Presentations

18/07/2024

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 to confirm the risks in Japanese are equivalent to non-Japanese.

It is recommended to include Japanese into a dose-finding study to identify inter-ethnic difference in dose-response relationship

This requirement has been waived from Dec 2023 especially for companies developing orphan drugs and paediatric indications prior participation in global clinical trials.

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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