Drug Evaluation Committee Drug Evaluation in the Future - What is the Significance of Japanese Data in International Joint Development? -ICH E17 "What is the Significance of Japanese Data in International Clinical Trials?

Data Science Subcommittee

July 2022

ICH E17 "Guidelines on General Principles for the Planning and Design of Global Clinical Trials" was issued as a notification (Step 5) in Japan in 2018 following the ICH Step 4 agreement in 2017, but its application does not seem to be widespread. In this report, we attempted to carefully explain the "scientific concept" underlying the ICH E17 Guideline in order to move forward into the future in light of the current situation where international co-development has become the mainstream development strategy, and furthermore, we discussed the ideal form of drug evaluation without being restricted by ICH E17.

We considered "drug evaluation" as a learning process to understand the efficacy and safety of a drug, and discussed what kind of thinking should be applied to drug evaluation from the development to the post-marketing stage, and how we can deepen our understanding of "factors influencing therapeutic efficacy" (←effect modifiers). We have come to the conclusion that a new axis of thinking is to deepen our understanding of "factors that influence therapeutic effect" (←effect modifiers and this report organizes them as such). We believe that thinking based on effect modifiers can be applied not only to international co-development, but also to drug development under various circumstances, such as drug development for rare diseases and special patient populations.

We hope that this report will be of help to all those involved in drug development, and that it will also serve as a foundation for the thinking of the next generation of drug developers.

Japan Pharmaceutical Manufacturers Association, Committee on Drug Evaluation
DS Subcommittee FY2020 TASF Force 5

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